Northwest Biotherapeutics: CEO Linda Powers’ Brilliant Manufacturing Strategy Has Created Enormous Shareholder ValueAcronyms Used in This Report MHRA Medicines and Healthcare products Regulatory Agency is the United Kingdom regulatory counterpart to FDA.… Why I Believe Northwest Biotherapeutics Has Been and Continues to be the Subject of a Powerful Stock Manipulation SchemeDCVax-L Impressive Phase 3 Results Are Validated by Independent, Expert Scientists and Physicians; Supports Strong Upward Stock Move The final results… Explanation of How Adam Feuerstein Has Egregiously Misrepresented the Results of the Phase 3 Trial of DCVax-LExecutive Summary I have tried to make this report as short and readable as possible so that in many cases I… Northwest Biotherapeutics’ Day Has Come at LastI’m Back Earlier this year I decided to end subscriptions to SmithOnStocks.com. Researching and writing articles on biotechnology companies required a… Presentation of DCVax-L Results from ASCO by Dr. Keyoumers AshkanHere is the link to a video from ASCO in which Dr. Keyoumers Ashkan summarized the results of the phase… Northwest Biotherapeutics: Adam Feuerstein Investigates Adam Feuerstein’s Understanding of Dendritic Cell VaccinesIntroduction Let me ask you a question? If Adam Feuerstein is trying to convince you that DCVax-L has no chance of… Adam Feuerstein Is Facing a Firestorm of Criticism for His Misrepresentation of Results in the Phase 3 Study of DCVax-L in Glioblastoma Multiforme; A Practicing GBM Physician Chastises HimF-stein Challenges Members of the Oncology Community Who Treat Glioblastoma Multiforme Adam Feuerstein has thrown down the gauntlet in alleging that… Northwest Biotherapeutics: Debunking Silly, Fictitious Adam Feuerstein Article Falsely Claiming Phase 3 Trial of DCVax-L in Glioblastoma Multiforme Was a FailureIntroduction I am really outraged. The long awaited phase 3 results for DCVax-L in newly diagnosed and recurrent glioblastoma multiforme were… Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 4) If The Phase 3 Data Is So Good, Why Hasn't Northwest Issued A Press Release?I have been getting a lot of questions on why Northwest Biotherapeutics has not issued press releases based on the… Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 3) Analyzing Hedge Fund Stock Manipulation TechniquesIntroduction This note describes why I believe that the sharp downward price movement yesterday resulted from stock manipulation by a group… Presentation at the New York Academy of Sciences on Final Results of DCVax-L Phase 3 Trial Showing Impressive Efficacy (Part 2) Incredibly Low p-Values on Median Overall Survival EndpointsEarlier today, I put out the first of a series of reports that I plan to issue on this presentation.… Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 1) Debunking Hedge Fund MisinformationOverview The much anticipated presentation at the New York Academy of Sciences of final results of the phase 3 trial of… Northwest Biotherapeutics (NWBO, $0.86, Buy) Addressing Key Questions Relating to the Possible Approval and Commercialization of DCVax-L in Glioblastoma MultiformeIntroduction The catalyst for writing this update was the MHRA certification of Northwest Biotherapeutics’ Sawston, UK plant for GMP production… Northwest Biotherapeutics: FDA Statement Regarding Use of External Controls in Clinical Trials is a Huge PositiveI put out a blog last week alerting subscribers that I am writing an update on Northwest Biotherapeutics. I continue… Northwest Biotherapeutics Issues Encouraging Update on Manufacturing Capabilities (NWBO, $1.59, Buy)Introduction This report addresses three issues: The capability of the Sawston UK plant to manufacture Northwest Biotherapeutics’ dendritic cell vaccine in… Antares: The Future Looks Really, Really Bright (ATRS, Buy, $4.18)Investment Thinking The fourth quarter conference call was very encouraging to me. The investment thesis is coming together much better and… Cryoport: Update on My Investment Thinking (CYRX, Buy, $49.35)Investment Thinking I believe that the stock of Cryoport can deliver exceptional returns over the next five, ten or more years.… Repligen: Some Thoughts for 2021 (RGEN, $223.28)Investment Overview I first recommended Repligen in an initiation report published on December 4, 2012 at a price of $6.12. Now… Cytokinetics: Catalysts for 2021 (CYTK, $18.79)Introduction I have shut down the subscription service for SmithOnStocks and have refunded subscription fees for those subscribers who paid their… Cryoport (CYRX, Buy, $66.00) and bluebird bio: Investment Significance of bluebird’s Decision to Temporarily Suspend Sickle Cell Disease Trials of LentiGlobin and Marketing of Zynteglo in EuropeCancer Concerns About bluebird bio’s Gene Therapy Products bluebird bio announced a temporary suspension of two trials of its LentiGlobin… Cryoport (CYRX, Buy, $72.30) Kymriah Sales are Strong and Equity Offering Was Well ReceivedKymriah Sales Were Strong in 4Q, 2020 Novartis just reported 4Q, 2020 worldwide sales for Kymriah of $141 million. This was… Cryoport: Comments on Just Completed Equity Offering and Surprising 15% Surge in Stock Price (CYRX, Buy, $73.75)Overview I wanted to give subscribers a quick overview of the just completed equity offering and the surprising 15% surge in… Cytokinetics: Approval of Merck’s Heart Failure Drug Vericiguat Increases My Confidence for Approval of OmecamtivThe FDA approval of Merck’s new heart failure drug, vericiguat, has meaningful implications for whether it will approve omecamtiv. Vericiguat’s… Cytokinetics: A Deep Dive into the Potential for Omecamtiv (CYTK, Buy, $19.86)Investment Overview Cytokinetics has three highly valuable pipeline assets whose aggregate value in my view substantially exceeds its current market valuation… Antares: Encouraging Revenue Guidance (ATRS, Buy, $4.00)Key Point I think that the stock has the potential to double in 2021. New Revenue Guidance Antares has just issued guidance… Cryoport; How Airlines Might Need Cryoport Dewars for Shipping of COVID-19 Vaccines (CYRX, Buy, $46.43)Just after I published my first article today, I received a copy of this article. It suggests that Cryoport dewars… Cryoport: Potential Commercial Benefits from COVID-19 Vaccines (CYRX, Buy, $46.43)The market has been manic depressive on assessing the potential commercial benefit of COVID-19 vaccines to Cryoport. The stock ran… Cytokinetics: Is Omecamtiv Mecarbil Approvable? Yes! (CYTK, Buy, $15.59)Key Points of the GALACIC-HF Trial Cytokinetics declined sharply after it announced topline results in the huge 8,500 patient phase 3… Cryoport: Comments on the Sharp Recent Price Swings (CRYX, $51.86, Buy)Cryoport's stock has been on a roller coaster ride over the past ten days as shown in daily closing prices… Cryoport: We Are Just in the First Inning (CYRX, Buy, $50.27)Key Investment Points I continue to be very bullish on the long term outlook for Cryoport. Listed below are some of… Northwest Biotherapeutics: Waiting for Top Line Data on DCVax-L (NWBO, $1.25 Buy)There has been frenetic trading in Northwest Biotherapeutics stock as investors await the release of topline data from the DCVax-L… Cytokinetics: There Still May Be Hope for Omecamtiv Mecarbil (CYTK, Buy, $16.54)Investment Opinion Data presented at the upcoming American Heart Association meeting on the phase 3 GALACTIC-HG trial on omecamtiv mecarbil could… Northwest Biotherapeutics: Reason for Yesterday’s Stock Surge (NWBO, Buy, $1.12)Overview Northwest Biotherapeutics stock was on fire yesterday as the price increased 35% to $1.12. The strength appears to be… Cytokinetics: Top Line Results for Omecamtiv in GALACTIC-HF Trial Are Perplexing (CYTK, $15.46)Cytokinetics reported that the results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and… Cytokinetics: Proposed Acquisition Price for MyoKardia Suggests CYTK is Dramatically Undervalued (CYTK, Buy, $27.33)Bristol-Myers Squibb has announced that it will acquire MyoKardia for $13.1 billion in cash and this has important implications for… Cryoport Update (CYRX, $42.24, Buy)Purpose of Note This note comments on two news events for Cryoport. The Company reported that it has completed the acquisitions… Antares: Xyosted Sales Projections for 2020 Through 2023 (ATRS, Buy, $2.62)Sales Projections for Xyosted Xyosted just completed its sixth full quarter of sales since its launch in 4Q, 2018. Almost all… Northwest Biotherapeutics: Two Recent Press Releases Indicate that Manufacturing is on Track to Support Commercialization of DCVax-L (NWBO, Buy, $0.55)Clinical Data Offers Much Hope that Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme Will Be Successful Northwest continues… Cryoport: My Take on the Recent Acquisitions and Strong Move in the Stock (CYRX, Buy, $55.50)Perspective Cryoport in a period of five days announced two strategic acquisitions, first of CryoPDP and then MVE Biological Solutions, that… Cryoport: The Acquisition of CRYOPDP Looks to Be a Major Coup (CYRX, $36.51, Buy)Overview Cryoport announced the acquisition of the French company, CRYOPDP on Thursday, August 20, 2020. The stock market gave the acquisition… Cryoport Has Staggering Growth Potential but Is the Stock Overpriced (CYRX, $33.51, Buy)Investment Thesis Since the market low on March 23, Cryoport’s stock has increased from a low of $14.58 to a current… Why Bother with Antares? (ATRS, Buy, $2.86)Investment Perspective Periodically, I get a comment from one subscriber regarding Antares to the effect of why are you bothering… Northwest Biotherapeutics: (NWBO, Buy, $0.35) Management Issues Guidance That DCVax-L Phase 3 Trial Results Will Be Released Sometime After Labor DayInvestment Overview: Highly Asymmetric Outlook Northwest Biotherapeutics has guided that it will report results of the phase 3 trial of DCVax-L… Northwest Biotherapeutics: We Are Just Several Weeks from Release of Topline Data in Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme (NWBO, $0.36, Buy)Investment Overview In the 1Q, 2020; 10-Q regulatory release on June 24, there was a section that went into some detail… Cytokinetics (CYTK, Buy, $20.97) Omecamtiv Nears the Finish Line; Topline Data Expected in 4Q, 2020 with Launch Possible in 2021Overview Cytokinetics was founded 22 years ago and has not deviated from its initial business model that is based on… Northwest Biotherapeutics (NWBO, Buy, $0.26) Detailed Results for the Phase 3, DCVax-L Trial in ndGBM Are ImminentIntroduction Results for the phase 3 trial of DCVax-L in the treatment of newly diagnosed glioblastoma multiforme (ndGBM) should be released… Antares (ATRS, Buy, $2.72) Effect of Covid-19 Appears Modest So Far On Company and Xyosted in ParticularInvestment Overview Antares stock has been more impacted by the market sell off than many other biotechnology stocks which have rebounded… Cryoport (CYRX, $23.71, Buy) : Great Potential for Substantial increases in Commercial Sales in the 2020 to 2024 TimeframeRecent Price Strength and Investment View The long term fundamentals of Cryoport are so strong that I anticipate I will be… Northwest Biotherapeutics: Why I Believe there is a High Probability for Approval of DCVax-L (NWBO, Buy, $0.21)Investment Overview There are Good Reasons to Believe that Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme Will Be… Cryoport: Pre-Announcement of 4Q Sales Negatively Impacted Stock; I Remain Bullish on the Stock (CYRX, Buy, $18.07)Fourth Quarter Biopharma Results Come Up Short Cryoport pre-announced 4Q, 2019 results on Friday January 10, 2020; audited full year results… Portola: My Investment Thinking After the Sharp Price Drop (PTLA, Buy, $14.85)Full Year Sales of Andexxa were Impressive but there was a Troubling Drop in Sequential Sales in US in 4Q,… Novocure: First Report on this Dynamic Growth Stock with Important Similarities to Northwest Biotherapeutics (NVCR, $78.77)Investment Overview My reason for first looking at Novocure in depth was that it provided important comparative information versus Northwest Biotherapeutics’… Cryoport: Exciting Clinical Data on CAR-T Drugs Points to Dramatic Growth (CYRX, Buy, $14.59)Investment Overview ASH is a Key Annual Event The annual meeting of the American Society of Hematology (ASH) is a closely watched… Antares: Detailed Sales and Earnings Projections for 2020, 2021 and 2022 (ATRS, Buy, $4.86)Objective of This Report Antares is an extremely difficult company to model on a sales and earnings basis. Its core technology… Cryoport: A Model Projecting How Commercially Approved Products Supported by Cryoport Will Drive Growth Through 2024 (CYRX, Buy, $15.12)Investment Perspective The main revenue driver for Cryoport from 2015 to 2019 came from providing cryogenic shipping services to companies conducting… Antares Pharma: Highlights from Presentation at Jefferies Healthcare Conference: (ATRS, Buy, $4.79)Purpose of Report I just listened to the presentation by Antares at the Jefferies conference in London on Wednesday, November 20… Northwest Biotherapeutics: Company is Closing in on Unblinding of the Phase 3 Trial of DCVax-L in GBM That Could Lead to a Cascade of Important Follow-On Events (NWBO, Buy, $0.22)Key Points In the third quarter 10-Q regulatory filing, it was disclosed that the draft form of the trial’s Statistical… Antares Pharmaceuticals: Projecting Very Strong Growth in Xyosted Sales for 2020, 2021 and 2022 (ATRS, Buy, $3.89)Key Points In my sales and earnings model for 2020, I will be using a working estimate of $53.6 million… Portola: Detailed Spreadsheet Projecting Sales and Earnings Through 4Q, 2021 (PTLA, Buy, $28.00)Key Points: The sales model presented in this report projects sales for Portola of $119, $264 and $402 million for… Antares Pharma: Quick Take on Implication of 3Q Results for Future Growth (ATRS, Buy, $3.70)Key Points: Xyosted launch continues to impress. Projecting sales of $22 million in 2019 and over $50 million in 2019 AMAG Pharmaceuticals: AdCom Votes 9 to 7 to Remove Makena from the Market, but I Don’t Think It Will Happen: AMAG (AMAG, $9.80), Antares Pharma (ATRS, $3.40, Buy)The FDA AdCom meeting voted 9 to 7 to withdraw Makena from the market. However, 6 of 7 practicing OB/GYNs… AMAG Pharmaceuticals (AMAG, $12.20); Antares (ATRS, Buy, $3.59) What Will FDA AdCom Recommend on Makena in the Aftermath of Failed Prolong Trial?Key Conclusions I believe that there is a 95% probability that Makena will remain on the market and only a 5%… Cryoport: Stock Has Been Attacked by Short Sellers (CYRX, $14.57, Buy)Opinion on Stock The recent sharp price decline has not been attributable to any change in perceived or actual fundamentals of… Aimmune Therapeutics: (AIMT, $23.63) Palforzia for Peanut Allergy Desensitization Has the Potential to Be a BlockbusterIntroduction Aimmune is the first company for some time on which I have picked up coverage. My screening criteria is not… Antares: Impressive Xyosted Prescription Trends Continue (ATRS, Buy, $3.30)Key Points: Xyosted prescription trends remain impressive and based on audit data for the last 11 weeks, there has been… Northwest Biotherapeutics: Management’s Decision to Determine Survival Tail for DCVax-L in Phase 3 Trial in Newly Diagnosed Glioblastoma Was Absolutely the Right Move (NWBO, Buy, $0.25)Key Points: NWBO is approaching unblinding of the critical phase 3 trial of DCVax-L in newly diagnosed glioblastoma (GBM). Antares: Update on Sales Projections for Xyosted (ATRS, $3.30, Buy)Investment Thesis I have seen seven plus months of data on prescription trends for Xyosted as estimated by the prescription auditing… Cytokinetics: Current Investment Thesis Is All About Omecamtiv Mecarbil (CYTK. $13.26, Buy)Investment Thesis is Almost Exclusively Driven by Prospects for Omecamtiv Mecarbil Omecamtiv Mecarbil is a Potential Mega- Blockbuster Omecamtiv mecarbil is one… Cryoport: Quick Take on 2Q Results (CYRX, $20.18, Buy)Cryoport reported a very strong quarter as sales increased by 83%. The key biopharma segment increased sales by 81%. This… Portola: Andexxa Looks to be a Blockbuster (PTLA, $30.00, Buy)Overview The investment story for Portola is virtually 100% based on the sales ramp for Andexxa. Skepticism and/ or uncertainty have… Antares: Highlights from 2Q, 2019 Conference Call (ATRS, $3.29, Buy)Introduction I have heard encouraging comments on my recently announced approach of doing shorter, less pedantic reports on new companies. This… New Approach to SmithOnStocks Reports Starts with Aimmune Therapeutics (AIMT, $18.73)My coverage strategy has been to identify stocks that I believed to be buys and initiate coverage with an in-depth… Antares Pharma: The Xyosted Launch Continues to Look Good (ATRS, Buy, $3.37)Investment Thesis The cornerstone of my positive investment thesis for Antares is Xyosted, which was fully launched in January 2019. While… Cryoport: I View the Just Completed Equity Offering as a Major Positive (CYRX, Buy, $18.00)Overview of Equity Offering Cryoport quickly and very successfully executed an equity offering after the close on June 19, 2019. It… Antares Pharma: Detailed Sales and Earnings Model Through 2021 (ATRS, $2.85, Buy)Investment Thesis Recently, I have received a couple of sarcastic comments to the effect that this stock has gone nowhere for… Antares Pharma: The Xyosted Launch Looks Like it will Meet or Beat Wall Street Expectations for 2019 (ATRS, Buy, $2.90)Investment Thesis The cornerstone of my positive investment thesis for Antares is Xyosted, which was fully launched in January 2019. While… Northwest Biotherapeutics: Takeaways from Marnix Bosch’s Presentation at ASCO (NWBO, Buy, $0.27)Overview Marnix Bosch, Chief Technical Officer of Northwest Biotherapeutics, discussed three broad topics at ASCO on Sunday June 2, 2019. Factors… Cryoport: Details of My Model for Sales for 2018 to 2024 (CYRX, Buy, $16.88)Key Points: I am projecting that total sales will increase from $19.6 million in 2018 to $31.0 million in 2019… Antares: Tracking Report on Xyosted Prescriptions (ATRS, Buy, $2.88)Introduction and Overview I have obtained access to weekly prescription trends for Xyosted which I will publish periodically. Marketing began on… Portola: Andexxa Sales in 1Q, 2019 Were Encouraging and Yet the Stock HasTraded Down (PTLA, Buy, $30.16)Overview of 1Q, 2019 Results I was shocked to see Portola trading down about $5.00 in following the release of 1Q,… Cytokinetics: Based on Data from Fortitude ALS Trial, Cytokinetics and Astellas Indicate They Will Undertake Phase 3 Trial of Reldesemtiv in ALS (CYTK, Buy, $9.30)Key Points: Trial missed achieving statistical significance on primary endpoint of slow vital capacity Repligen Stock Price Surges on Announcement of Preliminary 1Q, 2010 Results and Acquisition of CT Technologies (RGEN, Buy, $68.61)Business Accelerated Dramatically in 1Q, 2019 Repligen’s stock exploded on Friday April 26, 2019 as it increased $11.65 (up 20%) to… Portola: Detailed Update on Exciting 2019 Outlook (PTLA, Buy, $33.35)
Key The outlook for Portola’s stock price in 2019 and 2020 Antares (ATRS, Buy, $3.51); AMAG Pharmaceuticals (AMAG, $11.73) First Thoughts about How the PROLONG Study Could Affect Makena UsageIntroduction On Friday, the PROLONG clinical study was released that showed no difference in outcomes between Makena and placebo. This was… Cryoport: Great Buying Opportunity (CYRX. Buy, $10.44)
Quick Comment on 4Q, 2018 Sales and Cryoport Cytokinetics: A Focus on 2019 Stock Price Catalysts (CYTK, Buy, $5.82)
Investment Omecamtiv The primary driver of the investment thesis on Antares: Sales Growth Guidance for 2019 is Extremely Bullish (ATRS, $3.60, Buy)
Antares just reported Portola: NEJM Report on Positive Results in ANNEXA-4 Study is a Significant Positive (PTLA, Buy, $28.89)Overview This report focuses narrowly on the New Agenus: New Blockchain Financing Instrument Could Cause a Paradigm Shift in Financing Small Biotechnology Firms (AGEN, Buy, $3.37)
Key Agenus is the first biotechnology company to Bristol-Myers Squibb: A Highly Innovative Company Priced Like a Value Stock (BMY, Buy, $48.99)
Investment Investors have turned a thumbs down on the proposed Portola: Tidbits from Presentation at JP Morgan Healthcare Conference (PTLA, Buy, $21.96)
Investment Thesis in Andexxa is the only approved product for treating severe bleeds (sometimes Cryoport: The Bristol-Myers Acquisition of Celgene is a Validation of my Investment Thesis for Cryoport (CYRX, Buy, $9.05)Investment Thesis The proposed acquisition of Bristol-Myers-Squibb: Negative Market Reaction to Celgene Acquisition is a Buying Opportunity (BMY, Buy, $45.17)Key Points Investors have turned a thumbs down on the proposed Portola: Approval of Gen 2 Manufacturing Process for AndexXa is a Significant Positive (PTLA, Buy, $18.75)
Portola received approval for the Prior Approval Supplement Portola Pharmaceuticals: 2019 Is All About the Sales Trajectory of AndexXa (PTLA, $15.46, Buy)
Investment With the disappointing launch of Bevyexxa, almost all of the market value of Portola is based on AndexXa which was… Northwest Biotherapeutics: Non-Dilutive Financing Provides Major Boost to Investment Outlook (NWBO, $0.25, Buy)
Key Monetization of a UK manufacturing facility has brought in roughly $46 million of non-dilutive cash.I estimate that payment of debt… Cryoport Raises a $25 Million Warchest for Acquisitions (CYRX, $9.45, Buy)
Cryoport announced that it has closed on an investment from the healthcare investing firm Petrichor for $25 million. Petrichor will… Northwest Biotherapeutics: Blinded Data from DCVax®-L Phase 3 Trial is Extremely Encouraging, But We Still Need to See Unblinded Data (NWBO, Buy, $0.29)Overview This report starts with a summary of the key aspects of my investment thinking on Northwest,updated for the just reported… Antares: Multiple New Product Launches Make for Extreme Complexity in Earnings Forecasts for 2019 to 2021 (ATRS, Buy, $3.59)Investment Thesis in Brief: In this report, I have put together an earnings forecast projecting EPS of (0.04) in 2019, $0.19… Cryoport: Detailed Update and Updated Projections Based on 3Q Results (CYRX, Buy, $10.35)Key Points Cryoport continued to show explosive growth in the third quarter as sales increased 76% to $5.3 million led… Antares: Xyosted is Approved; Let the Good Times Roll (ATRS, Buy, $3.77)Investment Thesis At Last, Three Major Product Approvals in 2018 It has been a torturous wait for Antares’ very promising pipeline to… Regenerative Medicine: Thoughts on How to Invest in This Dynamic New TechnologyKey Investment Points of this Report Regenerative medicines promises to be a (the) major technology driving the biopharma industry in… Portola: Reiteration of Buy Recommendation (PTLA, Buy, S27.46)Introduction This is the latest in a series of updates on Portola and is prompted by information presented in the second… Antares: Investment Story has Shifted from Pipeline Promise to Commercial Potential (ATRS, $3.74, Buy)Investment Summary At long last, the exciting new product potential of Antares is becoming a commercial reality. A very significant milestone… AMAG Pharmaceuticals: Trying to Project 2019 Sales for the Makena Franchise (AMAG, $24.45, Buy)Investment Thesis The investment outlook for AMAG in 2019 is primarily about Makena and this report focuses almost entirely on how… Cryoport: Reiterating My Buy Recommendation (CYRX, Buy, $14.20)Investment Perspective On May 16, 2018, I published a report entitled Updated Sales and Earnings Model. The purpose of that report… Cytokinetics: Update based on 2Q, 2018 Conference Call (CYTK, Buy, $6.85)Investment Thesis Omecamtiv is the Essence of the Investment Thesis I continue to believe that Cytokinetics is an attractive investment based… Portola: Update and Reiteration of Buy Recommendation (PTLA, Buy, $39.31)Investment Thesis in Brief This report is based on presentations by management at recent brokerage conferences. It is an update and… AMAG Pharmaceuticals: Strong Launch of Subcu Makena and Pending Sale of Cord Blood Registry is Encouraging (AMAG, $23.55, Buy)Investment Thesis My April 13, 2018 report AMAG: Upgrading to Buy Based on an In-Depth Analysis of the Outlook for Makena… Northwest Biotherapeutics: There could be Overwhelming Patient Demand for DCVax-L due to the Right to Try law (NWBO, $0.24, Buy)Investment Thesis in Brief I believe that it is now a matter of when rather than if DCVax-L is approved and… Northwest Biotherapeutics; Five Spectacular Patient Outcomes for Patients Treated with DCVax-L as Reported at ASCO (NWBO, $0.28, Buy)Purpose of Report: At ASCO, Northwest sponsored a meeting attended by investigators in the phase 3 trial and other oncologists not… Northwest Biotherapeutics: Right to Try Law Potentially Could Lead to Meaningful Revenues Prior to Formal Approval of DCVax-L (NWBO, Buy, $0.30)Investment Perspective Last week, a manuscript was published in a peer reviewed journal that dealt with blinded results of the phase… Northwest Biotherapeutics: Blinded Data from Phase 3 Trial Strongly Suggests that DCVax-L is a Major Advance in the Treatment of Newly Diagnosed Glioblastoma Multiforme; It Looks Like NWBO Has Hit a Therapeutic and Commercial Home Run (NWBO, Buy, $0.25)Investment Hypothesis on Dendritic Cell Cancer Vaccines I have no academic background in immunology so that you should take that into… Cytokinetics: Update on Extensive Clinical Trials Being Conducted (CYTK, Buy, $9.45)Investment Overview and Thesis Cytokinetics has an extremely valuable asset in omecamtiv mecarbil, which it is developing in collaboration with Amgen;… Cryoport: Updated Sales and Earnings Model (CYRX, Buy, $9.69)Purpose of this Report With the commercial launches of the CAR-T products Kymriah and Yescarta, I am expecting a significant upward… Antares: Recent Launch of Makena Subcu Auto Injector and Probable Launches of Xyosted and AB Rated Generic to EpiPen Could Make for an Outstanding Price Performance in 2018 (ATRS, Buy, $2.36)Key Investment Issues In this report I focus on three very important product related issues that will likely drive the… AMAG: It Is Early Days, but the Launch of the Subcutaneous Dosage Form of Makena Seems to be Going Very Well (AMAG, Buy, $21.17)Investment Thesis The investment thesis for AMAG in 2018 and 2019is overwhelmingly dependent on how successful the Company will be in… Portola: Approval of AndexXa is a Major Positive (PTLA, Buy, $41.19)Investment Opinion Based on assumptions made in this report, I estimate that AndexXa could be valued by investors at $114 to… AMAG: Upgrading to Buy Based on an In-Depth Analysis of the Outlook for Makena Over the 2018 to 2020 Period (AMAG, Buy, $21.10))Investment Thesis in Brief I want to emphasize at the very outset of this report that the key takeaway is that… Antares Pharma: Approval of Xyosted on or before September 29, 2018 Is Highly Probable (ATRS, Buy, $2.12)Background on Xyosted NDA Resubmission Following Complete Response Letter The original PDUFA date for the Xyosted NDA was October 20, 2017,… Cryoport: Gilead Update on Yescarta Strongly Supports My View That Cryoport has Explosive Sales Growth; An Important Upward Inflection is Approaching (CYRX, $8.75, Buy)Investment Conclusions Along with most investors interested in Cryoport, I am expecting and awaiting a sharp upward inflection in sales as… Antares: FDA Comments from Type A Meeting Are a Best Case Outcome for Xyosted (ATRS, $2.13, Buy)Management Comments on Type A Meeting Antares released the following comment on March 27, 2018 that deals with the Complete Response… Portola: Why I Think that AndexXa is Likely to be Approved (PTLA, Buy, $36.44)Key Observations and Conclusions I believe there is a very strong possibility that AndexXa will be approved on its PDUFA… Cryoport: Continuing to Pound the Table on this Unique Growth Story (CYRX, Buy $9.17)Cryoport reported 4Q results pretty much in line with my expectations. In my last report on November 6, 2017, I… Antares: Things Are Looking Up (ATRS, Buy, $2.22)Overview of Report I listened to the presentation by CEO Bob Apple at the Raymond James conference on March 5th and… Portola: Uncertainty on AndexXa Approval Leads to 30% Decline in Stock Price (PTLA, Buy, $31.16)Major New Uncertainty for AndexXa The fourth quarter conference call produced alarming information about the FDA review of AndexXa. This drug… Antares Pharma: Makena SC Approval is a Big Positve; There are more Approvals to Come (ATRS, Buy, $2.35)Investment Thesis Finally, the FDA comes through with the approval for Makena SC. My Buy recommendation on Antares is based on… Northwest Biotherapeutics: How the Right to Try Remarks in President Trump State of the Union Could Favorably Affect Regulatory Action on DCVax-L and DCVax Direct (NWBO, Buy, $0.33)Introduction This report deals with comments made by President Trump in the State of the Union address in which he indicated… Bristol-Myers Squibb: Why I Believe Its Dominance in Cancer Immunotherapy Promises to Make BMY a Great Long-Term Investment (BMY, $62.70, Buy)Investment Opinion Conceptual Reason for Recommendation My recommendation of Bristol-Myers Squibb is in contrast to the small, not well-researched biotechnology companies on… Antares Pharma: Update on Xyosted (ATRS, Buy, $2.34)Regulatory Update Antares announced that it has scheduled a Type A meeting with FDA for Xyosted which is intended to resolve… Northwest Biotherapeutics: Two Lead Investigators on DCVax-L Phase 3 Trial Believe That It Could be a Major Therapeutic Advance in Treating Glioblastoma Multiforme (NWBO, Buy, $0.29)Reason for this Note I was prompted to write this note after listening to a July 2017, You Tube segment in… Northwest Biotherapeutics: Issues to Focus on in Pending Manuscript Dealing with Blinded Data from Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma (NWBO, Buy, $0.23)Purpose and Summary of This Report My key takeaway points are summarized at the end of this report. I urge you… Portola Announces a Delay in PDUFA Date for AndexXa (PTLA, Buy, $54.86)Portola announced after the close on December 22, 2017 that the FDA will extend its review of AndexXa (andexanet alfa)… Antares' Response to Complete Response Letter on Xyosted is in Line with My Expectations (ATRS, Buy, $2.05)Antares Pharma announced on December 21st that it had submitted a request to the FDA for a type A meeting… Portola: US Launch of Bevyexxa Is Scheduled for Early January 2018 (PTLA, Buy, $50.03)Portola Pharmaceuticals announced today that the FDA has given the go-ahead for the commercial launch of Bevyxxa (betrixaban). This drug… Cytokinetics: VITALITY-ALS Trial Fails (CYTK, Buy, $8.00)CYTK announced today that the VITALITY-ALS trial in ALS failed which is obviously a significant disappointment. The stock is trading… Alimera : Changing from A Buy to Hold (ALIM, $1.20, Hold)After four years of following Alimera and never having a Buy on the Company, I upgraded to a Buy in… Antares Pharma: My Hypothesis on Issues that Resulted in the CRL for Xyosted and Potential Timing of Approval (ATRS. Buy, $1.63)Investment Thesis Xyosted is viewed by investors as the most important product in Antares” broad pipeline. In anticipation of approval… Portola: Management Guides to a Highly Probable US Launch of Bevyexxa in the December to February Timeframe (PTLA, Buy, $50.52)Perspective on Stock Price Behavior I began coverage of Portola with a Buy in a May 4, 2017 report at… Cryoport: This Unique Company is Poised for Explosive Sales Growth; Price Weakness is a Buying Opportunity (CYRX, Buy, $6.68)Investment Thesis By my analysis, Cryoport and its stock are coiled like a spring for future strong performance. My model is… Cytokinetics: Even if Tirasemtiv Were to Fail in Vitality-ALS. There is Great Long term Stock Potential (CYTK, $14.25, Buy)Critical VITALITY-ALS Data Is Imminent During the 3Q conference call, Cytokinetics said that the still unknown results of the VITALITY-ALS trial of… Antares: Approval of Xyosted is a Matter of When, Not If (ATRS, $2.12, Buy)The Issue Antares received a complete response letter for Xyosted that did not cite any questions relating to efficacy, manufacturing, quality… Antares Pharma: FDA Action to not Approve Xyosted on its October 20, 2017 PDUFA Date is Perplexing (ATRS, Buy, $2.23)Overview Investors have had high confidence that Xyosted would be approved by the FDA on its October 20, 2017 PDUFA date.… Repligen: More Detailed Analysis on GE Decision to Manufacture Protein AOverview GE Healthcare, announced plans to launch a new chromatography resin in the first half of 2018 which will not use… Portola: Reiterating Buy and Refuting Recent Negative Blog by Adam F-stein (PTLA, Buy, $54.12)Introduction Adam F-stein wrote an article on Portola on September 19, 2017 with the headline “Commercial launch of Portola’s new blood… Northwest Biotherapeutics: Thoughts on Why the Phase 3 Trial of DCVax-L is Ongoing (NWBO, BUY, $0.17)Overview The phase 3 trial of DCVax-L in newly diagnosed glioblastoma is continuing even though it has passed the 248 PFS… Northwest Biotherapeutics, Bristol-Myers Squibb: Success for the Yervoy-Opdivo Combination in CHECKMATE-214 Trial Obviously is a Major Positive for BMY, but also has Important Implications for NWBO (NWBO, Buy, $0.19) (BMY, $60.80, Buy)The stoppage at an interim analysis of Bristol-Myers Squibb’s’ CHECKMATE-214 trial provides meaningful information into assessing the potential fro success… Portola: September 4 Conference Call Provides Update on Potential Launch Date for Bevyxxa and Announces Price (PTLA, Buy, $57.29)Investment Overview Following approval of Bevyxxa, Portola stated that it expected to launch in the US in the September to November… Northwest Biotehrpeutics: How Does DCVax-L Clinical Data Compare to the CAR-T Therapy Axi-Cel? (NWBO, $0.18, Buy)New Seeking Alpha Article on Seeking Alpha An article on Seeking Alpha called Northwest Biotherapeutics: Statistically Satisfying was just published by… Antares Pharma: This Small, Emerging Biotechnology Company Is Poised for Explosive Growth Based on Five Major New Product Introductions by 2020 (ATRS, Buy, $3.02Investment Thesis Antares is one of my top recommendations based on its extremely impressive pipeline prospects. In a March 23, 2017… Alimera Sciences: Company Achieves Breakeven Pretax Cash Flow in 2Q, 2017 Despite Slow Unit Demand for Iluvien (ALIM, Buy, $1.50)Investment Perspective Alimera’s second quarter results threw investors (and me) a sweeping curve ball. I initiated coverage on May 31, 2013… Cryoport: As Its Clients Transition from Clinical Development to Commercial, Growth Could Be Explosive (CYRX, $6.89, Buy)Investment Perspective Cryoport is in the very early stages of corporate development and has only minimal sales ($9.8 million on a… Portola Pharmaceuticals: AndexXa BLA Resubmitted; Reiterating Buy (PTLA, $61.41, Buy)Investment Thesis Portola issued a press release on August 3, 2017 that reported it had just resubmitted the BLA for AndexXa,… Cytokinetics: Reiteration of My Long Standing Buy Recommendation Based on an Extraordinary Pipeline (CYTK, $12.90, Buy)Investment Overview and Thesis Investment Overview Cytokinetics reported 2Q, 2017 sales and earnings results on Wednesday, August 2 but this was relatively… Cryoport: Upping 2020 Price Target from $14.50 to $20.00 (CYRX, Buy, $6.89)Overview Before reading this report, I would suggest reviewing my initriation report on Cryoport of April 12, 2017 and my update… My Approach to Investing in CAR-T Drug Development: Cryoport (CYRX, Buy, $5.67)); Kite (KITE, Neutral, $104.34); Juno (JUNO, Neutral, $27.87), Novartis, (NVS, No opinion, $84.85)Report Highlights The pending approval of Novartis’ Car-T drug tisagenlecleucel is the beginning of a new era of drugs based… Cryoport: Thoughts About FDA AdCom Meeting on Novartis’s CAR-T Drug Tisagenlecleucel (CYRX, Buy, $4.86)An FDA advisory committee will consider the BLA for Novartis’s CAR-T product tisagenlecleucel tomorrow, July 12th for the treatment of… Northwest Biotherapeutics: Why I Believe That the Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Patients Has a Very Good Chance for Success (NWBO, Buy, $0.17)Overview This report is an extensive update on almost everything I know about the DCVax-L phase 3 trial and is over… Windtree Therapeutics: Phase 2b Trial Fails Although There Was An Encouraging Signal of Activity (WINT, Take tax loss, $0.34)Key Points: The phase 2b trial failed, but there was an encouraging signal of activity. Portola Pharmaceuticals: Betrixaban Approval Triggers Big Stock Move-Now What Do We Do? (PTLA, Buy, $55.42)Investment Thesis There was considerable uncertainty as to whether the FDA would approve betrixaban so that the approval caused a sharp… Repligen: Market Likes Spectrum Acquisition and So Do I (RGEN, Buy, $43.20)Investment Thesis I view the acquisition of Spectrum, Inc. as a significant positive for Repligen as I will discuss shortly. I… Portola: Reiterating Buy Prior to June 24th PDUFA Date for Betrixaban (PTLA, Buy, $39.35)Portola has two drugs in late stage development that I believe are likely to be approved in 2017 or early… Alimera Sciences: Iluvien Sales Seem to Have Caught Traction; It Is Time to Buy! (ALIM, Buy, $1.35)Key Points In 1Q, 2017 unit sales of Iluvien increased 34% in the US and foreign unit sales increased 32%.Management… Windtree Therapeutics: Discussion of Licensing Deal with Lee’s Pharmaceutical and Two Imminent Key Clinical Events (WINT, Buy, $0.90)Introduction This report discusses a new licensing deal with Lee’s Pharmaceutical and alerts investors to two upcoming catalysts for the stock.… Windtree Therapeutics: Thinking About the Stock Price After Phase 2b Results for Aerosurf in RDS Are Released In July (WINT, $0.92)Investment Thesis Windtree is facing the ultimate of binary events when it releases topline results in July for its critical phase… Cryoport: Observations on 1Q, 2017 Results (CYRX, Buy, $3.05)Investment Section This report is a follow-up to my April 12, 2017 report “Cryoport: Initiating Coverage of this Highly Unique Health… Cytokinetics: What Are the Implications for Tirasemtiv Following the Approval of Radicava (Edaravone) for ALS? (CYTK, Buy, $15.40)Key Points: The surprising and unconventional approval of Radicava (edaravone) shows how desperate the FDA is to expedite the approval… Portola Pharmaceuticals: Initiating Coverage with a Buy (PTLA, $40.05) Overview of Report Thoughts on the Probable Launches of the First CAR-T Drugs; Cryoport is a Novel Way to Invest In This: Cryoport (CYRX, Buy, $2.36) and Kite (KITE, Neutral, $83.37)Key Points: I continue to think that first ever CAR-T drug approval will be for Novartis’ CTL-019 in r/r pediatric… Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with… Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)Introduction I am recommending purchase of Cryoport, which has developed a first mover, business model for providing cold chain logistics for… Repligen: A Business Update and Reiteration of Buy (RGEN, Buy, $34.11)Investment Overview and Thesis A Long Buy Recommendation of Mine I first recommended Repligen in an initiation report in December 2012. At… Cytokinetics: Insights into Corporate Collaborations, Tirasemtiv, CK-107 and Hospitalization Caused by Heart Failure (CYTK, Buy, $11.25)Introduction I was just going though the most recently published slide deck of Cytokinetics and found some slides that I thought… Kite Pharma: Novartis and Kite File for Regulatory Approval of Their CAR-T Products; I Do Not Believe That KITE Has a Meaningful First Mover Advantage (KITE, Neutral, $82.19)Key Points: Novartis will almost certainly gain approval for CTL-019 in r/r pediatric ALL early in 4Q, 2017. This would… Northwest Biotherapeutics: Is There Any Chance for DCVax-L to be Successful in the Phase 3 Trial? (NWBO, Buy, $0.24)Acronyms Used in this Report SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by… Antares: Pipeline is Bursting with Late Stage Products (ATRS, $2.77, Buy)Key Points: Antares has an impressive portfolio of seven new products that could lead to explosive growth over the next… Cytokinetics: A Look at the Clinical Trial Programs Underway (CYTK, Buy, $13.00)The Investment Thesis Is Based on Three Drugs in Late Stage Development In partnership with Amgen, Cytokinetics has advanced omecamtiv mecarbil… Cytokinetics: Estimating a Potential 2025 Price Target of $220 Based Only on the Potential for Tirasemtiv (CYTK, Buy, $13.00) and Ignoring Omecamtiv Mecarbil and CK-107Key Points: Cytokinetics is likely to report results from the phase 3 VITALITY-ALS trial in early December 2017. I believe… Cytokinetics: Estimating a Potential 2025 Price Target of $172 Based Only on the Potential for Omecamtiv Mecarbil and Ignoring Tirasemtiv and CK-107 (CYTK, Buy, $13.00)Key Points: Amgen and Cytokinetics have begun enrolling the phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure… Kite Pharma: Analysis of Six Month Data from ZUMA-1 That Led to 40% Price Increase (KITE, Neutral, $72.53)Report Preface In the event that you are unfamiliar with acronyms used widely in this report such as CAR-T, DLBCL, TFL,… Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)Two Recent Cancer Vaccine Trial Failures Spurred this Report On February 22, 2017, Argos reported that the Data Monitoring Committee for… Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been… Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)Key Points: Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18… AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring… Cytokinetics: Discussion of Financing Deal with Royalty Partners (CYTK, Buy, $11)Terms and Implications of This Deal Cytokinetics announced that it had concluded a deal to sell a portion of the future… AMAG and Antares: Update on the Development of Makena SC (AMAG, Neutral, $24.40) (ATRS, Buy, $2.04)Key Points: Recent announcement that AMAG will not pursue Orphan Drug Exclusivity for Makena SC has hammered the stock of… Bristol-Myers Squibb: Disappointing Recent Press Release Causes Sharp Drop in Stock Price; I Remain at Buy (BMY, Buy, $49)The New Press Release Bristol-Myers Squibb’s stock declined from $55.49 at the close on Thursday January 19 to $49.23 at the… Bristol-Myers Squibb: Implications of Potentially Earlier than Expected Introduction of Keytruda Combined with Chemotherapy in the First Line Lung Cancer Setting (BMY, Buy, $56.31)Investment overview Yesterday, BMY traded down sharply due to President-elect Trump’s statements on drug pricing and Merck’s announcement that the FDA… SmithOnStocks Top Stock Picks for 2017, January 3, 2017Purpose of this Report I last summarized my stock recommendations in a September 12, 2016 report. There has been little change… Northwest Biotherapeutics: DCVax-L Viewed Through the Eyes of Dr. Linda Liau, Lead Investigator on the Phase 3 Trial of DCVax-L (NWBO, $0.35, Buy)Principal Takeaway Messages from This Report Dr. Linda Liau believes that use of DCVax-L can result in 25% of glioblastoma patients… Updating My Investment Thinking on Kite (KITE, Neutral, $47.63) and Juno (JUNO, Neutrl, 17.86) in the Aftermath of the ASH MeetingIntroduction to Report I was closely watching the Amercian Society of Hematology (ASH) meeting held during December 3 to 6 for… Immuno-Oncology is Probably The Most Explosive Commercial Opportunity in All of BioPharma; My Investment Picks are Bristol-Myers Squibb (BMY, Buy, $57.14) and Agenus (AGEN, Buy, $4.28))Background Information on Checkpoint Modulation Let me provide background information that shapes my views on immuno-oncology before I get into my… My Current Investment Thinking on Kite (KITE, Neutral, $50.02) and Juno (JUNO, Neutral, $20.14) and the CAR-T Space as a WholeKey Investment Conclusions I believe that Juno will cease development of JCAR-015 and turn to JCAR-017 as its lead CAR-T… Cytokinetics: Results of COSMIC HF Published in The Lancet; Phase 3 GALACTIC HF Trial Has Started (CYTK, Buy, $12.00)Key Points Results from the COSMIC HF phase 2 trial of omecamtiv mecarbil support the hypothesis that it improves heart… Northwest Biotherapeutics: Phase 2 Trial in Colorectal Cancer with Liver Metastases Announced (NWBO, Buy, $0.55)NWBO is preparing for the start of a phase 2 trial combining DCVax-L with Merck’s Keytruda in late stage colorectal cancer with… Antares: Teva Projects Launch of AB Rated Generic to EpiPen in Early 2018 (ATRS, Buy, $1.87)Eyal Desheh is the Chief Financial Officer of Teva. During the recent third quarter conference call, he answered a question… Antares: Some Key Points from 3Q, 2016 Conference Call (ATRS, Buy, $1.84)Investment Opinion In my opinion, Antares is substantially undervalued. My price target is $6 60 in 2018. The thinking behind this… Cytokinetics: My Relative Market Value Analysis Suggests that the Stock Should be Selling at More Than $20 (CYTK, Buy, $8.95)Investment Thesis Cytokinetics looks to me to be seriously undervalued when I contrast its market value (stock price multiplied by shares… Windtree Therapeutics (WINT, Take Tax Loss, $2.50): Critical Aerosurf Phase 2b Trial Completion is Delayed; Can the Company Raise the Capital Needed to Complete the TrialOverview Windtree held a conference call on October 25 to update investors on the status of the phase 2a trial of… Kite Pharma: Highlights of October 18, 2016 Analysts' Day- I Remain More Cautious on the Stock than Mainstream Wall Street Analysts (KITE, Neutral, $46.45)Key Points; The most important data point between now and yearend 2016 is release of data from ZUMA-1 that shows… Northwest Biotherapeutics: Recent Data Update on Phase 1/2 Trial of DCVax Direct is Encouraging (NWBO, Speculative Buy, $0.43)Key Points: Data for DCVax Direct recently was updated for its phase 1/2 trial in 40 patients having 13 different… Kite Pharma: Interpretation of Results from the Interim Look at ZUMA-1 (KITE, Neutral, $60.25)Overview Kite released a press release with topline data on the interim look at the ZUMA-1 trial. This note interprets information… Kite Pharma Part 5: Detailed Research That I Have Done In Coming to My Opinion on Kite (KITE, Neutral, $$54.06)Investment Opinion Kite will be reporting interim results of the phase 2, ZUMA-1 trial of its lead product KTE-C19 by the… Antares: Updates on QST and AB Generic to EpiPen; Reiteration of Buy Recommendation (ATRS, Buy, $1.65)Overview and Investment Opinion In my opinion, Antares is substantially undervalued. My price target is $6 60 $8 in 2018 and… Kite Pharma Part 4: A Preview of Highly Anticipated Results from Interim Look at ZUMA-1 (KITE, Neutral, $54.95)Key Points: I think that an imminent press release dealing with topline results from an interim look at the ZUMA-1… Kite Pharma Part 3: A Detailed Analysis of the Design of the All-Important ZUMA-1 TrialReport Overview This is the third part of the series of reports that I have written on Kite Pharmaceuticals. I… Kite Pharma Part 2: An Overview of CAR-T Cell Drug Development EffortsOverview This section tries to give a brief, layman’s overview on the potential role of CAR-T cells in treating certain hematological… Kite Pharma: Part 1- Glossary of Terms and AcronymsIntroduction I have been working on a report on Kite for over three months and have in front of me a… Northwest Biotherapeutics: My Hypothesis as to Why the Company Has Been Silent on Its Clinical Trial Programs and Why DCVax-L Might Succeed in its Phase 3 Trial (NWBO, Speculative Buy, $0.34)Investment Thesis I have been pretty much silent on Northwest Biotherapeutics for some time. The reason is that as an analyst… Cytokinetics; Amgen and Servier Announce Decision to Move Omecamtiv Mecarbil into Phase 3 (CYTK, Buy, $12.07)Amgen issued a press release today in which it announced that Servier had decided to exercise its option to commercialize omecamtiv… Antares; Are Mylan's Woes A Potential Positive for AB Rated Generic to EpiPen (ATRS, $1.37, Buy)You cannot turn on the business news channels without hearing extensive comments and condemnation by pundits and politicians about Mylan's aggressive… Antares: Comment on Strength in the Stock Price (ATRS, $1.29, Buy)A number of people have asked me if I know of any specific reason for the strength in Antares's stock… Cytokinetics: Tirasemtiv Completes Phase 3 Enrollment (CYTK, Buy, $11.89)Cytokinetics has announced that the VITALITY-ALS trial of tirasemtiv has completed enrollment. The study includes three phases. The first is… Celldex: Update Based on 2Q, 2016 Conference Call (CLDX, Neutral, $4.45)Investment View Celldex has a broad array of clinical trials underway or in planning that involve five drugs. However, most of… Repligen: Very Strong Growth in Sales and Earnings Continues (RGEN, 29.37, Buy)Investment Thesis Repligen’s operating business results continue to be very strong as second quarter bioprocessing sales increased 36%. For perspective, full… Alimera: Iluvien Sales are Encouraging but the Company is Financially Stressed (ALIM, $1.79, Neutral)Investment Perspective I first started writing reports on Alimera in May of 2013, but have never recommended the stock. I thought… Agenus: Update on Drug Development Programs (AGEN; Buy, $5.65)Investment Thesis This report focuses on product development efforts discussed in Agenus’ 2Q, 2016 conference call. My most likely investment scenario… Cytokinetics: Collaboration with Astellas is Expanded and Will Bring in $65 Million of Cash (CYTK, $10.45, Buy)Overview of Expanded Collaboration Cytokinetics and Astellas announced on July 27th that they had expanded their collaboration for the development of… Galenica to Acquire Relypsa for $32 per Share (RLYP)Galenica has announced a tender offer to acquire all shares of Relypsa for $32 per share which on a fully… A Non-Consensus, More Balanced Look at the CAR-T Development Efforts of Kite and Juno (Kite, $48.53: Juno, $30.42)Definition of Key Terms Used in This Report Engineered Autologous T-cells (eACTS): These are T-cells that are removed from a patient… Juno Therapeutics: FDA Quickly Lifts Its Clinical Hold on ROCKETThe FDA has decided to lift the clinical hold on the ROCKET trial. Lifting the hold is not a great… Juno Therapeutics: Comments on Deaths in the ROCKET CAR-T Clinical Trial of JCAR-015(JUNO, $27.87)Investment Perspective I have been watching Kite and Juno for nearly two years and have occasionally written on the companies. I… Cytokinetics: Phase 2 Trial of CK-2127107 in COPD Begins (CYTK, $9.37, Buy)Overview of COPD Cytokinetics announced today that it is beginning a phase 2 trial of CK-2127107 in chronic obstructive pulmonary disease… Antares Pharmaceuticals: Teva Launches AB Generic to Imitrex (ATRS, Buy, $1.06)Teva announced today the launch of its AB rated generic to Imitex (sumatriptan). Remember that Antares books revenues from Teva… AMAG Pharmaceuticals: Initiation of Research on a Complex but Potentially Very Interesting Investment Situation (AMAG, Neutral, $24)Organization of Report The first five pages of this report (section 1) provide a quick summary of my view of AMAG’s… Northwest Biotherapeutics: Going Over My Thoughts (NWBO, $0.62)Overview The naming of five distinguished scientists with extensive knowledge and expertise in immune-oncology to Northwest’s scientific advisory board is the… Relypsa: Company Releases Veltassa Launch Metrics for May (RLYP, $18.14, Buy)Investment Thesis Veltassa continues its slow but steady launch. The May results were in line with my projections and I… Antares Pharmaceuticals: Highlights on Makena from AMAG Pharmaceuticals Analyst Day (ATRS, $1.14, Buy)Report Overview Antares and AMAG Pharmaceuticals are jointly developing a new subcutaneous formulation of AMAG’s key drug Makena which is currently… Relypsa: FDA Issuance of a CRL for ZS-9 is a Significant Positive (RLYP, Buy, $18.50)Investment Thesis The receipt of a CRL for ZS-9 delays its possible approval by perhaps one year or more which substantially… Relypsa: Comments on Possible Outcomes of ZS-9 PDUFA DateI have previously written that the Veltassa launch sales figures are not likely to excite investors for some time. However,… Caladrius Biosciences: The Business Model is Intriguing, But the Cash Position Is Weak (CLBS, $0.57, No Opinion at this time)Investment Overview I am interested in Caladrius Biosciences primarily because of the potential for its PCT cell therapy manufacturing business. PCT has… Relypsa: Analyzing April Results of the Veltassa Launch (RLYP, Buy, $14.00)Investment Overview Investors are closely watching the launch progress of Veltassa following its December 2015 introduction. Medicare and managed care have set… Relypsa: Update Following 1Q, 2016 Conference Call (RLYP, Buy, $14.15)Investment Thesis for Relypsa The investment issues for Relypsa are complex. Its key drug Veltassa was launched in December of 2015… Windtree Therapeutics: Key Points from Conference Call on 1Q, 2016 Results (WINT, $2.04)Investment Thesis The current market valuation of Windtree is only $16 million. This seems extremely low for a Company that… Chimerix: Thinking on the Stock in the Aftermath of Results from the AdVise Trial (CMRX, $4.95)Overview In a report published on April 14th I recommended purchasing Chimerix at a price of $5.67. The catalyst for my recommendation… Northwest Biotherapeutics: The Company Provides an Operations Update (NWBO, $1.23)Report Overview I usually start my reports with a summary and investment thesis. However, in this report I am putting this… Antares: Presentation Highlights from Deutsche Bank Conference (ATRS, Buy, $0.97)Overview I listened to CEO Bob Apple speak at the Deutsche Bank conference and wanted to pass along a few pieces… Antares: AMAG Issues Guidance on Timing of Subcutaneous Makena (ATRS, Buy, $1/05)I recently wrote a report on Antares entitled Makena has the Potential to Make a Very Significant Contribution to EPS that… Agenus: Its Market Leading Position in Immuno-Oncology Makes it A Compelling Investment Story (AGEN, Buy, $3.69)Investment Thesis in Brief I continue to recommend Agenus for its impressive technology platforms in immuno-oncology. It is difficult to assign… Antares: An Outstanding Product Pipeline Promises Dramatic Growth Through 2022 (ATRS, Buy, $0.92)Investment Thesis in Brief If you like numbers, you will like this report. It is a very detailed analysis of the… Relypsa: Analyzing March Results of the Veltassa Launch (RLYP, Buy, $17.60)Investment Perspective Investors are closely watching the launch progress of Veltassa following its December 2015 introduction. Medicare and managed care have… Chimerix: An Intriguing Near Term and Long Term Outlook for the Stock (CMRX, Buy, $5.67)Investment Thesis in Brief Antares: Makena Has the Potential to Make a Very Significant Contribution to EPS (ATRS, $0.85. Buy)Investment Thesis The launch of Otrexup has been extremely disappointing in contrast to my high expectations. Medac launched a competitive… Relypsa: Comments on Takeover RumorsReason for Report Relypsa shares surged from about $15.00 at 1 PM on Thursday April 7 to close at $24.34. This… Discovery Laboratories: Clinical Trial Data over Next Year Could Validate the Promise of Aerosurf (DSCO, Buy, $1.60)Investment Overview The Stock Market Has Written off Aerosurf The current stock market valuation for Discovery Laboratories of $13 million (8 million… Cytokinetics: Amgen’s R&D Chief Expresses Great Optimism About Omecamtiv Mecarbil for Treating Congestive Heart Failure (CYTK, Buy, $6.53)Purpose of This Report I have written frequently about omecamtiv mecarbil, Cytokinetics’ extremely promising new drug for congestive heart failure… Northwest Biotherapeutics: A Comprehensive Evaluation of Its Lead Product DCVax-L (NWBO, $1.50)Perspective and Overview on this Report The still unexplained and unresolved halt in screening for the phase 3 trial of DCVax-L… Relypsa: It Is Early Days in the Launch of Veltassa but the Momentum Seems Quite Strong (RLYP, Buy, $13.46)Investment Perspective Investors are closely watching the launch progress of Veltassa follwoing its December 2015 introduction. Medicare and managed care have… Northwest Biotherapeutics: Why the Failure of Celldex’s Rintega in Newly Diagnosed Glioblastoma Probably Has No Implications for the DCVax-L TrialInvestment Thesis Some subscribers have asked me if the failure of Rintega in the phase 3 ACT-IV trial in newly diagnosed… Cytokinetics: Comments on the Patent Situation of Omecamtiv Mecarbil (CYTK, Buy, $6.40)Introduction If you read my note of yesterday, there can be no question that Amgen views omecamtiv mecarbil as a major… Cytokinetics: Extremely Encouraging News from Amgen on Omecamtiv (CYTK, Buy, $6.54)Introduction The Cowen conference in Boston is going on this week. I consider Cowen to have the best and broadest coverage… Celldex: ACT IV Trial of Rintega in Newly Diagnosed Glioblastoma has Been Terminated (CLDX, Hold, $4.01)ACT-IV Trial is Halted The independent Data Safety and Monitoring Board (DSMB) just completed its second interim review of the phase… Antares: Disappointing News on AB Rated Version of EpiPen (ATRS, $0.95)Investment Perspective Teva filed a 6-K regulatory document last night that stated: “Teva received a complete response letter on February 23, 2016 relating… Relypsa: An In-depth Analysis of Early Results of the Veltassa Launch (RLYP, Buy, $13.26)Investment Perspective Relypsa is about two months into the launch of Veltassa, its first product. There was a time (several years… Relypsa: New Buy Recommendation on Relypsa (RLYP, Buy, $14.98)Investment Thinking in Brief pSivida: One Step Away from Upgrading the Stock (PSDV, Hold, $2.80))Investment Overview pSivida holds a unique, leading position in developing inserts that provide long acting delivery of drugs to the retina… Cytokinetics: An Update Based on CEO Robert Blum’s Comments at BIO CEO Conference on February 8, 2016 (CYTK, Buy, $6.57)Summary I attended the BIO CEO conference in New York City on February 8 and 9. I am writing a series… Discovery Laboratories: New CEO and Update on Aerosurf (DSCO, $2.26)Upcoming Key Events There are two very important events in the next year. The first is reporting of results in a… Neuralstem: An Update on Its Pipeline and Supporting Clinical Trials (CUR, Neutral, $1.00)Purpose of this Report Chimerix: Upgrading the Stock to a Buy (CMRX. Buy, $6.10)Definitions of Key Words This section defines a number of words, phrases and acronyms that I have used in this report… Antares: Undeterred by the Poor Stock Performance I Continue to Pound the Table (ATRS. Buy, $1.30)Upcoming Catalysts This is a detailed note updating my thinking on Antares and discussing how I come up with my 2017… Derma Sciences: Close to Upgrading (DSCI, $4.54)Investment Perspective With the failure of its biotechnology drug candidate aclerastide, Derma Sciences is abandoning drug development efforts. The Company… Cytokinetics: An Update on Potential (Highly Probable) Phase 3 Trial of Omecamtiv Mecarbil in Heart Failure (CYTK, Buy, $11.29)Purpose of this Report I listened carefully to CEO Robert Blum speaking at the Piper Jaffrey conference on December 1. This… Repligen: A Detailed Update; Recent Price Drop Makes Me More Positive (RGEN, Buy, $28.50Repligen’s Outstanding Business Model Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment… Discovery Laboratories: Results for Aerosurf in Phase 2a Trial are Encouraging; Why Then Did the Stock Crash? (DSCO, Buy, $0.30)Introduction This report discusses the results of Discovery Laboratory’s first in human, phase 2a trial of Aerosurf. In writing this report,… Cytokinetics: I Predict Amgen Will Proceed to Phase 3 Trials with Omecamtiv Mecarbil (CYTK, Buy, $10.82)Investment Thesis I continue with my long standing buy recommendation on the stock. I think a Buy at this level is… ZS Pharma: Astra Zeneca to Acquire ZS Pharma at $90 per Share-DARN (ZSPH, $90)On Friday, November 9, 2015 Astra Zeneca entered into a definitive agreement to buy ZS Pharma in an all-cash tender… Antares: An Update on My Investment Thinking (ATRS, Buy, $1.33)Investment Thesis This has been a very disappointing year for Antares investors; the stock closed at $2.57 on December 31, 2014… Northwest Biotherapeutics: Seeking Alpha Publishes Latest in a String of Attack Articles Authored by Short Sellers (NWBO, $4.92)Seeking Alpha has published an extremely negative article by anonymous short sellers that alleges criminal misconduct on the part of management… Cytokinetics: Positive Topline Results of Omecamtiv in COSMIC-HF Trial Are a Major Positive (CYTK, Buy, $7.04)
There is a very high probability that omecamtiv will now be taken into phase 3 development. I await Amgen’s decision… Northwest Biotherapeutics: New Financing from Woodford was Much Needed (NWBO, $5.44)Curses, Foiled Again; The Hedge Fund’s Lament The clear intent of the recent short attack on Northwest was at a minimum… Northwest: Analysis of a Coordinated Short Selling Attack Against the Stock (NWBO, $4.69)A Suspect Plunge in Price On Friday October 16, 2015 a day in which the Dow Jones and S&P averages increased… Neuralstem: My Analysis of Phase 1 and Phase 2 Results for NSI-566 Neural Stem Cells in ALS Indicates Encouraging Signals of Efficacy (CUR, Buy, $1.25)Putting This Report in Perspective This is an extensive report that goes over the aggregate results of the phase 1 and… Antares: The Stock Price Does Not Reflect the Fundamentals (ATRS, $1.60, Buy)Introduction Antares recently updated its corporate presentation on their website. .There were several slides in the presentation that reinforce my confidence… Neuralstem: Initial Thoughts on Just Released Encouraging Phase 2 Data on the Use of NSI-566 Stem Cells to Treat ALS. Neuralstem Will Proceed to a Potentially Registrational Trial in 2016 (CUR, Buy, $1.50)Introduction Neuralstem released this morning (September 29) new information from principal investigator Eva Feldman on phase 2 data from the use… Northwest Biotherapeutics: My Thoughts on the New Data from the Phase 1/2 Trial of DCVax Direct (NWBO, Buy, $6.91)Critical Issue in Interpreting the Data Agenus (AGEN: Buy, $6.61) Royalty Deal for QS-21 Adjuvant Use in Two Glaxo VaccinesTerms of the Royalty Deal Agenus announced on September 9th that it had signed a royalty transaction with Oberlan Capital from… Northwest Biotherapeutics: Thoughts on Suspension of Screening of New Patients in the Phase 3 DCVax-L TrialReason for Report On August 21, Northwest put out a press release that said that screening of new patients has been… Neuralstem: The 2015 Decline in the Stock is in Contrast to Encouraging ALS Data and an Impressive Pipeline (CUR, Buy, $1.38)Investment Background Neuralstem has been absolutely pummeled this year as the price has declined from a closing of $2.72 on December… Celldex: Meaningful Data on Two Lead Products, Rintega and glembatumumab, is not Likely Before 2017 (CLDX, Hold, $16.99)Key Points; The big news of the 2Q, 2015 conference call was that the FDA has discouraged Celldex from filing an… Discovery Laboratories: Update from the 2Q, 2015 Conference Call Provides Timelines for Important Aerosurf Phase 2 Trials (DSCO, Buy, $0.47)Key Points Phase 2 trials are enrolling rapidly. Quick Take on Antares Following 2Q, 2015 Conference Call (ATRS, Buy, $2.10)Investment Opinion Antares stock has been pummeled by the “so far” disappointing launch of Otrexup and uncertainty as to when or… Chimerix: An Update (CMRX, $52.83, Neutral)Company Description Chimerix is focused on the development and commercialization of antiviral drugs. Its lead product brincidofovir is a phospholipid derivative… Cytokinetics: Comments on Sharp Price Decline After 2Q, 2015 Conference Call (CYTK, Buy, $6.28)Key Points The reasons for my buy recommendation on CYTK as detailed in previous reports remain the same. There was nothing… Cytokinetics: Phase 3 Trial of Tirasemtiv Has Begun (CYTK, Buy, $7.17)Cytokinetics announced on July 14, 2015 the start of the phase 3 trial of tirasemtiv in ALS-VITALITY-ALS (Ventilatory Investigation of… Discovery Laboratories: What I Intend to Do in the Aftermath of a Disastrous Stock Offering (DSCO, Buy, $0.54)Quick Summary Repligen: Fundamentals Are Exceptional But The Stock Carries A Premium Valuation (RGEN, $39.97, For Paid Subscribers)Investment Thesis When I wrote my first report on Repligen on December 4, 2012, I concluded that Repligen had one of the… Cytokinetics: Phase 3 Trial for Tirasemtiv About to Begin with Topline Results Possible in 2H, 2016; Successful Outcome Could Make the Stock a Homerun (CYTK, $6.35, Buy, For Paid Subscribers)Introduction Management has recently provided details of the upcoming phase 3 trial of tirasemtiv in the treatment of ALS; this trial… Discovery Laboratories: An Analysis of Phase 2a Results for Aerosurf and What to do with the Stock (DSCO, $0.81, for paid subscribers)Glossary of Important Definitions For those of you who are not familiar with terms used in neonatology, I am starting this… Antares: One of My Top Stock Picks for 2015 and 2016 (ATRS, Buy, $2.40, For Paid Subscribers)Introduction to Report One of my assets is also one of my biggest drawbacks. When I am writing on a Company… Observations from ASCO on Immuno-oncology with a Focus on Northwest Biotherapeutics’ (NWBO, Buy, $9.43) DC-Vax-Direct© and the Checkpoint Inhibitors of Bristol-Myers Squibb and MerckKey Investment Points Stemming from ASCO I have been going over data presented at ASCO on immune-oncology products and have been… Comments on Alimera (ALIM, $4.46, Neutral) and pSivida (PSDV, $3.97, Neutral)SmithOnStocks Mailbox My mailbox comments are brief articles on stocks in which I am involved. These can come from… Cytokinetics: Takeaways from Recent R&D Day and Reiteration of Buy (CYTK, $6.14, Buy)Investment Overview I find the recent stock weakness in Cytokinetics perplexing. The Company has a market value of about $300 million… Agenus: Its R&D Day Presentation Puts a Focus on the Great Promise of Cancer Vaccines and Checkpoint Modulators (AGEN, Buy, $6.73)Overview of Report I found the Agenus R&D day to be extremely interesting as it showcased the impressive immunotherapy technology base… Cytokinetics: Update and Reiteration of My Buy Recommendation (CYTK, $5.54, Buy)Investment Thesis in Brief Northwest Biotherapeutics: FDA Panel Recommendation to Approve Amgen’s Cancer Vaccine is Hugely Significant In Regard to Possible Approval of DCVax-L and DCVax Direct. (NWBO, $7.86, Buy)Overview An FDA advisory panel on April 30 recommended by a vote of 22 to 1 that Amgen’s cancer vaccine talimogene… CAR-T Companies-Kite (KITE, $55.09) and Juno (JUNO, $47.30): Is The Bloom Coming Off The Rose? Are Investor Expectations Unrealistic?Introduction to This Thought Piece Emerging biotechnology stocks obviously are very hard to value on an absolute basis because they usually… Initiation Report on ZS Pharma (ZSPH, Buy, $40.97, Subscribers only)ZS Pharma Investment Thesis The most important piece of the… Antares: Teva Offer to Buy Mylan Should Have No Effect on Launch of AB Rated Generic to EpiPen (ATRS, $2.76, Buy)Overview Subsequent to my posting of my recent update on Antares, I have seen that Teva has made an offer to… Antares: Detailed Sales and Earnings Projections for 2015 and 2016 (ATRS, Buy, $2.77, subscription required)Investment Thesis Discovery Laboratories: Focus is Totally on Aerosurf Development (DSCO, $1.43, Hold)Investment Thesis During the conference call on March 16, 2015 discussing 4Q, 2014 results, management announced that it had decided to… Northwest Biotherapeutics: Comments on Two AACR Posters (NWBO, $8.62, Buy)Introduction I have included an abstract on DCVax Direct and another on DCVax-L that will be presented in poster presentations at… Celldex Pipeline Update and Investment Thesis (CLDX, Moving from Buy to Hold, $28.56)Overview Northwest Biotherapeutics: The $40 Million Woodford Financing is A Major Positive (NWBO, Buy, $7.76)
The $40 million will fund the Company through the end of 2015. Northwest Biotherapeutics: Still Another Rebuttal to a Feuerstein Attack Is Called ForIntroduction Adam Feuerstein just published a blog that attacks the results and conclusions drawn from the paper summarizing results from the… Northwest Biotherapeutics: Promising New Data Was Just Presented on DCVax-L in Recurrent Glioblastoma Multiforme (NWBO, Buy)Executive Summary Neuralstem: A Closer Look at Encouraging Phase 2 Results for NSI-566 Neural Stem Cells in Treating ALS (CUR, Buy, $2.36)Observations about the Phase 2 Trial Results I spent the weekend thinking about the data released in the phase 2 trial… Neuralstem: Initial Take on Top Line Results of Phase 2 ALS Trial of NSI-566 Neural Stem Cells (CUR, Buy, $3.08)The topline data for the phase 2 trial of NSI-566 stem cells were released today. The initial stock reaction indicates… Cytokinetics: Updates on Tirasemtiv and Omecamtiv (CYTK, Buy, $7.77)Investment Overview Neuralstem: When Will We See the Phase 2 Data for NSI-566 in ALS? (CUR, Buy, $3.75)Management has guided that the phase 2 data on 15 patients treated in the phase 2 trial of NSI-566 neural… Northwest Biotherapeutics: How Much Will It Cost to Manufacture DCVax-L (NWBO, Buy, $7.26)There has been a lot of speculation about how much it costs to manufacture one course of individualized therapy of… ImmunoCellular Therapeutics: Is There an Investment Case to be Made? (IMUC, $0.57)Investment Background The purpose of this report is to get investors re-engaged with ImmunoCellular Therapeutics (IMUC). On December 11, 2013 the… Cytokinetics: Key Catalysts for 2015 Strongly Support My Buy Recommendation (CYTK, $7.85)Catalysts for 2015 Alimera Sciences: Some Thoughts on the Upcoming US Launch of Iluvien (ALIM, Neutral, $5.29)Investment Thesis I have been speaking with ophthalmologists, investors and Alimera (ALIM) management about the upcoming Iluvien launch. As I… The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology Landscape (NWBO, Buy, $6.19)Investment Overview Linda Powers was invited to the 7th Annual Phacilitate Immunotherapy Forum in Washington D.C. to speak on the potential… Alimera Sciences: Will The Launch of Iluvien Be Disappointing to Investors? (ALIM, Neutral, $5.53)Investment Issues Notes from Linda Powers Presentation in San Francisco, January 12, 2015 (NWBO, Buy, $6.00)Overview Linda Powers spoke at the Biotech Showcase Conference in San Francisco on January 12, 2015. My Buy recommendation on Northwest Biotherapeutics… Agenus: The Collaboration with Incyte is Transformative and Creates Great Shareholder Value (AGEN, Buy, $4.99)
Incyte’s expertise in clinical development and commercialization of cancer drugs is a perfect complement to Agenus’ product development capabilities for… Derma Sciences: Sales Guidance for 2014 is Lowered Again; 2015 Sales Guidance is Given for the First Time (DSCI, Hold, $9.40)Derma Sciences announced preliminary sales results for 2014 of $83.7 million which represents a 5% increase over 2013. This was… Cytokinetics (CYTK, Buy $5.52) New Collaboration with Astellas on CK-2127107 Greatly Improves Investment Outlook
This deal adds a third leg to the development pipeline at Cytokinetics along with omecamtiv for congestive heart failure and… Possible Impact of Merck Acqusition of Cubist on the Trius CVRI was just asked about the potential impact on the value of the Trius CVR of the Merck acquisition of… Discovery Laboratories: Delay in Completion of Aerosurf Phase 2a Trial and Continued Disappointing Sales of Surfaxin Weigh on the Stock (DSCO, $1.53, Hold)
Phase 2a Aerosurf trial completion has been pushed back to 1Q, 2015 from 4Q, 2014. Northwest Biotherapeutics: Putting Recent Clinical Data on DCVax Direct in Perspective (NWBO, Buy, $5.37)
Immuno-oncology is one of the most exciting areas for cancer research and cancer vaccines should be considered as a promising… Antares: 2015 Could Be the Breakout Year for the Stock (ATRS, $2.24, Buy)
I project 2015 sales of Otrexup at $22 million; if so, it would be generating profit in the latter half… Northwest Biotherapeutics: Capital Raise of $35 Million could be a Positive Catalyst for the Stock (Buy, $5.14)
Neil Woodford, a highly respected UK portfolio manager has just invested $25 million on very favorable terms and the Company… Celldex, Moving to A Buy (CLDX, $14.16)Investment Thesis Celldex held a conference call after the close on Friday, November 14, 2014 to discuss the interim results of… Cytokinetics: An Update on Tirasemtiv and Omecamtiv Mecarbil (CYTK, Buy, $3.67)Investment Thinking Cytokinetics could announce the decision on whether it will advance tirasemtiv into a pivotal phase 3 trial by the… Chimerix: A Review of Recent Analyst Day Presentations with a Focus on Adenovirus and Ebola (CMRX, $31.31, Neutral)
The fundamental outlook for Chimerix is very attractive in my opinion. My model suggests that sales of its lead drug… Northwest Biotherapeutics: Exciting News on Potential for Early Patient Access for DCVax-L in the UK
UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program. Northwest Biotherapeutics: National Geographic Special Features DCVax Direct Treatment of Stage 4 Pancreatic Cancer Patient (NWBO, Buy, $5.90)
DCVax Direct was used in a patient with stage 4 pancreatic cancer whose chemotherapy was stopped. Antares: Thoughts on FDA Briefing Documents for September 17th Advisory Committee Meeting on Testosterone Replacement Products (ATRS, $2.14, Buy)
The FDA does not appear to be concerned about cardiovascular risk with testosterone replacement products so this is a major… ImmunoCellular Therapeutics LTD: Thoughts on Management’s Plan to Move ICT-107 into Phase 3 (IMUC, Neutral, $1.02)Investment Overview ImmunoCellular and its dendritic cell cancer vaccine ICT-107 were written off as failures in December of 2013 after it… Neuralstem: Previewing Upcoming Important Events and Some Thoughts on the StemCell Patent Infringement Lawsuit (CUR, $3.62 Buy, August 26, 2014)Key Points The phase 2 trial of NSI-566 in 15 ALS patients has completed enrollment (surgeries) and final topline data could… Antares Pharmaceuticals: An Update on Key Issues (ATRS, Buy, $2.14)Investment Thesis Antares (ATRS) common has been hit with a storm of concerns that has caused the stock to decline from… Discovery Laboratories: My Current Thinking on the Surfaxin Launch and Aerosurf Phase 2 Trials (DSCO, Buy/Hold, $1.62)Investment Thesis At the time of launch of Surfaxin on November 8, 2013 Discovery Laboratory’s (DSCO) stock was selling at $2.00.… Northwest Biotherapeutics: Independent Chairman of the DMC Committee for DCVax-L Phase 3 Trial Chastises Adam Feuerstein for Inaccurate Articles (NWBO, Buy, $6.43)
The Data Monitoring Committee (DMC) is charged with monitoring the safety and efficacy results of clinical trial. The committee and… Cytokinetics: More Thoughts on the Potential for a Phase 3 Trial of Tirasemtiv in ALS (CYTK, Buy, $4.20)Investment Thesis In listening carefully to Cytokinetics’ (CYTK) comments over the last three months, I am convinced that the Company will… CREW Alleges That Adam Feuerstein is Involved in Stock Manipulation Scheme in Regard to Northwest BiotherapeuticsCitizens for Responsibility and Ethics in Washington (CREW) have gone after Adam Feuerstein of The Street.com. They have accused him… Inovio: Successful Phase 2 Trial in Cervical Dysplasia Provides Proof of Concept for the Technology Base (INO, $12.98, Neutral, Subscribers Only)Inovio’s Immunotherapy Technology Base Over two decades ago, the creation of naked DNA vaccines gave the promise of a significant advance… Northwest Biotherapeutics: Market Research Firm Evaluate Pharma Projects 2020 Worldwide Sales of $2.0 billion for DCVax-L (NWBO, Buy, $5.92)One of the basic charges made against me by Richard Pearson and other short sellers is that they maintain that… Agenus: Encouraging Data on Prophage, But What is the Path Forward (AGEN, Buy, $3.28)Introduction On July 1, Agenus announced results from a non-randomized, phase 2 study of its therapeutic cancer vaccine Prophage in newly… Antares; My View of How Otrexup and Medac’s New Product Rasuvo May Compete (ATRS, Buy, $2.54)Investors Are Concerned About Rasuvo’s Impact on Otrexup Investors have been concerned about the potential effect on Otrexup if the private… Cubist Pharmaceuticals: An Overview Based on a Recent Company Presentation (CBST, No Opinion)Introduction I recently was invited to attend a broker sponsored conference for biotechnology companies. Altogether, there were 116 companies presenting at… Neuralstem: Phase 1b Results for NSI-189 are Very Encouraging but It Is Early Days (CUR, Buy, $4.38, For paid subscribers)Investment Thesis on Neuralstem I continue with my long standing buy on Neuralstem that is almost entirely based on the potential… Derma Sciences: Highlights of the June 17th Analysts’ Meeting (DSCI, Buy, $11.07, Free content)Price Target Thinking In my initiation report of January 31, 2014, I argued for a 2018 price target of $20 to… Cytokinetics: I Think That the Company May Decide to Do A Phase 3 Trial with Tirasemtiv (CYTK, $4.70, Buy, For Subscribers Only)Overview on Clinical Status of Tirasemtiv I believe that Cytokinetics (CYTK) will decide to move tirasemtiv into phase 3 registration trials… Northwest Biotherapeutics: The Investment Tide May be Turning Positive (NWBO, Buy, $6.41, free content)Purpose of Report This report goes over recent news on the company in regard to DCVax Direct and DCVax-L and then… Repligen Makes An Excellent Acquisition (RGEN, Hold/ Buy, $19.04, free content)The Bioprocessing Business of Refine Technology Repligen (RGEN) has just announced the acquisition of Refine Technology. The primary reason for the… ImmunoCellular; Thoughts on Its Plan to Move ICT-107 Forward into Phase 3 Trials Based on Data Presented at ASCO (IMUC, $1.34, Neutral, Free Content)Investment Overview ImmunoCellular (IMUC) presented an update on the phase 2 results of ICT-107in glioblastoma multiforme or GBM at ASCO in… Discovery Laboratories: An Update on the Surfaxin Launch and the Phase 2 Clinical Trial Program for Aerosurf (DSCO, Buy, $1.72)Introduction and Overview This note updates recent progress of the company along with my detailed investment outlook which I break into… Northwest Biotherapeutics: Management Discusses Interim Data on Phase 1/2 Trial of DCVax-Direct (NWBO, Buy, $6.00, free content)Introduction Northwest Biotherapeutics held a conference call on May 27th to discuss interim results of its phase 1/2, first in human,… Antares: Although it is Still Early, I Think That Otrexup Launch is Going Very Well (ATRS, Buy, $2.93, Paid subscribers)Investment Thesis The broad based business model of Antares results in its receiving revenues from numerous products that are marketed by… Chimerix: Moving to a Buy (CMRX, $14.22, Paid subscribers)Investment Thesis I wrote a major report on Chimerix on March 13, 2014. I had been working on the report for… ImmunoCellular Has Plans to Move ICT-107 Forward into Phase 3 Trials; Should It? (IMUC, $1.19 Trading Buy, For Paid Subscribers)Investment Overview ImmunoCellular (IMUC) and its dendritic cell cancer vaccine ICT-107 were written off as failures late last year after the… Derma Sciences: An Update and Re-iteration of Buy Recommendation (DSCI, Buy $9.50, For Paid Subscribers)Investment Perspective in Brief I am re-iterating my Buy recommendation on Derma Sciences (DSCI) as I believe that it presents an… Neuralstem: An In-Depth Look at NSI-189, A Novel Small Molecule Drug Being Studied in Major Depressive Disorder (CUR, Buy, $3.60, For Paid Subscribers)Investment Thesis My recommendation of Neuralstem (CUR) has been based primarily on the potential for its neural stem cells NSI-566 in… Neuralstem: Dr. Eva Feldman’s Latest Presentation on The Use of CUR’s Stem Cells in ALS (CUR, Buy, $4.04)Overview Repligen Has an Outstanding, Stable Business and Excellent Long Term Growth Potential (RGEN, Hold/ Buy, $14.07, Paid Subscribers Only)Investment Background and Company Overview Ed Quilty, CEO of Derma Sciences, Outlines His Strategy to Build the Premier Wound Healing Company (DSCI, $12.00)Investment Thesis I published an extensive report on Derma Sciences (DSCI) on January 31, 2014 in which I recommended purchase. I… Linda Powers, CEO of Northwest Biotherapeutics, Attacks and Debunks the Weak Bear Case in a Presentation on March 27Overview Northwest Biotherapeutics CEO Linda Powers made a presentation yesterday in which she addressed the bear case that has resulted in… Antares (ATRS, Buy, $4.00) Why I Think That the Otrexup Launch Will Be A Success (Paid Subscribers Only)Recent Price Behavior Antares’ (ATRS) price has drifted down since the approval of Otrexup for the treatment of rheumatoid arthritis and… Agenus (AGEN, Buy, $3.73) Thoughts on the Stock and Company in the Aftermath of Trial Failure of MAGE-A3 Cancer VaccineAgenus (AGEN) and GlaxoSmithKline (GSK) announced that the MAGRIT phase 3 study of GSK’s MAGE-A3 cancer vaccine in non-small cell… Neuralstem (CUR, Buy, $4.48) Publishing of Phase 1 Results in Annals of Neurology Causes Price Surge (Paid Subscribers Only)Introduction The final results of the phase 1 trial of Neuralstem’s (CUR) NSI-566 spinal cord stem cells in the treatment of… Chimerix is A Company Focused on Infectious Viral Diseases that Has Investment Characteristics Similar to Trius (CMRX, Neutral, $25.48) (Subscribers Only)Report In Brief Agenus: There Has Been a Positive,Transformational Change in the Investment Thesis (AGEN, $3.67)This note is based on a presentation that was made by Bob Stein at the BIOCEO conference: he is the… Cytokinetics: An In-Depth Look at the Potential for Success of Tirasemtiv in the BENEFIT-ALS Trial in ALS Patients (CYTK, $9.50) (Subscribers Only)Purpose of This Report The biggest clinical trial event in all of biotechnology for 2014 could be the reporting of phase… The BIO CEO Conference: Highlights from the Meeting and New Investment Perspectives (Subscribers Only)Back From BIO CEO Conference I have returned from spending two days at the BIO CEO conference at the Waldorf Astoria… Derma Sciences: An In-Depth Look at An Emerging Growth Stock (DSCI, $12.77) (Subscribers Only)Investment Perspective in Brief Derma Sciences presents an unusual and attractive biotechnology investment situation. We are all aware of the binary… San Francisco Trip Is the Basis for a Preview of 2014 (Subscribers Only)What SmithOnStocks Is All About pSivida: Why I Think the Stock Could Do Very Well in 2014 (PSDV, $4.12) (Subscribers Only)Highlights of Dinner Neuralstem: Sizing Up Potential Key Events of 2014 (CUR, $3.42)Investment Thesis and Overview Senesco Offers a New Approach to Cancer Treatment and Dr. Phillip Frost Is Now With the Company (SNTI, $5.31) (Subscribers Only)Investment Overview Progress in the treatments of most cancers is a gradual and incremental process in which very few therapies can… pSivida: Game On for Iluvien (PSDV, $4.29)Alimera (ALIM) and pSivida (PSDV) released some extremely encouraging news on Iluvien. They said that Alimera had entered into labeling… Agenus: Encouraging Phase II Results for Prophage in Recurrent Glioblastoma (AGEN, $3.00)Purpose of This Report Agenus issued a press release on December 16, 2013 in regard to the final results of a… ImmunoCellular: Post Hoc Analysis of Disappointing Phase II Trial of ICT-107 (IMUC, $1.02)Investment Conclusion on ImmunoCellular The results of the phase II trial of ImmunoCellular's (IMUC) ICT-107 were disappointing as they did not… Celldex: I View the Recent Data on Rindopepimut as Encouraging (CLDX, Hold, $22.52) (Subscribers Only)Report Overview Northwest Biotherapeutics: An Analysis of Its Transforming Balance Sheet Restructuring (NWBO, $4.14)Key Takeaway Points of this Report Celldex: Equity Offering is a Positive for the Stock (CLDX, Hold, $25.88)Celldex (CLDX) has just announced a financing in which the Company has issued 7.0 million shares and will receive net… Celldex Stay Tuned for Monday’s Conference Call on Rindopepimut (CLDX, Hold, $28.31)Investment Significance of Upcoming Conference Call Repligen: Looking At 2014 and Beyond- Potential for EPS Growth (RGEN, $12.78) (Subscribers Only)Investment Thesis I think that Repligen's (RGEN) bioprocessing businesses is one of the best business models that I have seen in… Discovery Laboratories (DSCO, $2.07): An Asymmetric Opportunity ImmunoCellular Thoughts on Potential Outcomes for the Phase II Trial of ICT-107 in Newly Diagnosed Glioblastoma (IMUC, $2.31) (Subscribers Only)Investment Viewpoint Celldex (CLDX, $23.06): Previewing the Imminent Data Release on RindopepimutInvestment Background and Thesis Celldex Initiation Report: Pipeline Promise Has Been Embraced by Wall Street (CLDX, Hold, $22.79)Review of Amazing and Volatile Stock Price Performance Agenus and Glaxo: Sizing Up the Potential for the RTS,S Malaria Vaccine (AGEN, $2.94)Putting Malaria Vaccine Results in Perspective for Agenus pSivida: Previewing the October 17th PDUFA Date for Iluvien (PSDV, $5.07)Investment Scenarios: The Positive and Negative Case Discovery Laboratories: What the Marketing Approval of Surfaxin Could Mean to the Stock (DSCO, $2.72)Surfaxin is Finally Cleared for Commercialization in the US Cytokinetics: Presentation at Heart Failure Society Suggests Myocardial Infarctions Are Not Likely Associated with Omecamtiv Mecarbil (CYTK, $7.61)Investment Background Agenus: Rebuttal To Attack By Adam Feuerstein on the Company (AGEN, Buy, $2.85)Report Overview Neuralstem: Evidence Increasingly Suggests its Neural Stem Cells are Effective in ALS (CUR, $2.57)Thoughts on the Stock Price Agenus: Thoughts on Phase II Results for Prophage in Glioblastoma (AGEN, $2.91)Reason for This Report NovaBay: Phase II Topline Results for Auriclosene in UCBE are Very Encouraging (NBY, $1.52)Investment Overview NovaBay: Data from Phase II Trial of Auriclosene in Urinary Catheter Blockage and Encrustation is Imminent (NBY, $1.40)Company Overview and Purpose of the Report Agenus: Assessing Stock Prospects in the Aftermath of MAGE A-3 Cancer Vaccine Missing Primary Endpoint in Melanoma (AGEN, $2.81)Investment Thesis Cytokinetics: Clinical Investigators’ Take on ATOMIC-AHF Trial Results (CYTK, $8.01)Introduction Agenus: Upcoming Clinical Trial Results for the MAGE A-3 Cancer Vaccine Will Have a Major Impact on the Stock (AGEN, $3.42)Investment Overview Antares: An In-Depth Look at Otrexup and Re-iteration of My Buy Recommendation (ATRS: $4.45) (Paid Subscribers Only)Investment Overview and Thesis Repligen: A Buy and Hold Stock: OPUS Promises to be a Dynamic New Product (RGEN; $9.87)Report Summary Cytokinetics: A Preview of Key Upcoming Clinical Trial Results (CYTK, $10.17)Introduction Trius Therapeutics to be Acquired by Cubist (TSRX: $13.66)Implications for Trius Shareholders Agenus: Key Clinical Events are Imminent (AGEN, $3.91)Key Value Drivers for Agenus Through 2015 How Iluvien May Benefit Alimera and pSivida (PSDV, $3.25)Investment Perspective on Iluvien The investment outlooks for pSivida (PSDV) and Alimera (ALIM) in 2013 will be driven by issues related… Transcept: Throwing in the Towel on Intermezzo (TSPT, $3.56)Intermezzo was launched by Transcept’s marketing partner Purdue in April 2012. I believed then and now that it is a… Northwest Biotherapeutics: Moving DC Vax-L Rapidly Forward and Starting DC Vax Direct Trials (NWBO, $3.63)Investment Thesis Neuralstem: Anticipating More Efficacy Data from ALS Trial (CUR, $1.18)Investment Opinion and Thesis Repligen Promises To Be a Cash Flow Machine (RGEN, $6.88)Investment Overview ImmunoCellular Therapeutics: A Close Look at Key Issues for the Ongoing Phase II Trial of ICT-107 (IMUC, $2.69)Investment Thesis Cytokinetics: Critical Phase IIB Data is Upcoming in 2013 for Omecamtiv Mecarbil and Tirasemtiv (CYTK, Buy. $6.30)Key Investment Considerations Cytokinetics Has Two Key Drugs in Phase IIb Development Cytokinetics (CYTK) has been the pioneer in developing new drugs… Discovery Laboratories: The Surfaxin Launch and Beyond (DSCO, $2.38)Investment Thesis InSite Vision: Positive Phase III Trial Results for BromSite Reduces Much of Downside Risk in the Stock (INSV.OB, $0.30)BromSite Results are Strikingly Positive in First Phase III Trial NovaBay: Topline Data from Two Phase IIb Trials Presents an Asymmetric Investment Opportunity in 2013 (NBY, $1.24)Introduction Trius: Topline Data of Second Phase III Trial of Tedizolid is Eminent (TSRX, $6.76)Investment Summary and Conclusion I began recommending Trius (TSRX) with an initiation of coverage report that was published in May of… Cadence: Potential Near Term Catalyst for the Stock (CADX, $5.34)Investment Thesis I continue with my buy recommendation on Cadence Pharmaceuticals (CADX). I believe that there is a high probability for… Northwest Biotherapeutics: My Rationale for Having a Buy Recommendation (NWBO; $3.29)Crossing Swords Northwest Biotherapeutics: A Critique of Adam Feuerstein of TheStreet's Recent Analysis (NWBO, $3.50)Purpose of this Report Transcept: The Prescription Trend Watch for Intermezzo is On (TSPT, $6.63)Introduction Discovery Laboratories: Innovative Financing is a Catalyst to Buy the Stock (DSCO, $2.16)Investment Perspective Athersys: The Coming Year Will Define Its Adult Stem Cell Product MultiStem (ATHX, $1.63)Investment Perspective Sangamo: Paradigm Shifting Approach to Gene Altering Leads to Unique Product Opportunities (SGMO, $9.56)I have followed the progress of Sangamo for over seven years. I listened to a presentation by Edward Lanphier, CEO… A.P. Pharma: PDUFA Date on APF530 Looms and I Am a Buyer (APPA.OB, $0.70)Investment Opinion and Background MELA Sciences: In This Put Up or Shut Up Year, I Think the Company Will Succeed with its Launch of MelaFind (MELA, $1.70)MelaFind Trius: Why Last Friday’s Equity Offering is good for the Stock (TSRX, $4.90)Investment Opinion Trius (TSRX) completed an equity offering on Friday January 19 in which it sold 6.3 million shares at $4.465.… Transcept: Purdue Fires Big Marketing Guns and FDA Issues Insomnia Drug Guidelines That Help Intermezzo (TSPT, $5.72)Investment Opinion This Could Be the Coming Out Year for Inovio (INO, $0.72)I had the opportunity to meet with some of Inovio's (INO) management team- Joseph Kim (Chief Executive Officer), Peter Kies… Northwest Biotherapeutics: Transformed from an Ugly Duckling Bulletin Board Company to a Promising NASDAQ Company (NWBO, $3.20)Investment Update Trius Therapeutics: In an About Face, Congress is Helping Biotech Companies That Are Developing Antibiotics (TSRX, $5.54)Investment Opinion Cadence Pharmaceuticals: Sentiment is Shifting from Bearish to Bullish (CADX, $4.90)Investment Perspective and Opinion InSite Vision: Upcoming Topline Results from Clinical Trials Presents a Buying Opportunity (INSV.OB, $0.34)Investment Overview and Opinion Discovery Laboratories: Disappointment with the Delay in the Surfaxin Launch Has Created a Buying Opportunity (DSCO, $2.24)Introduction OncoSec Medical Initiation of CoverageIntroduction Repligen: Initiating Coverage with a Buy (RGEN, Buy, $6.13)Investment Opinion Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment outlook. For years,… NovaBay Swings for the Fences with NVC-422 Trial In Viral ConjunctivitisInvestment Thesis Initiating Coverage of Neuralstem with a Buy (CUR, $0.92)Product Development Overview Focusing on the Impetigo Indication for NVC-422 (NBY, $1.29)Investment Thesis NovaBay's Robust Clinical Pipeline Approaches Critical Clinical Trial Results in 2013Investment Thesis Settlement Between Pfizer and Teva on Generic Zyvox is a Significant Positive for Trius TherapeuticsThe Issue Northwest Biotherapeutics and ImmunoCellular Therapeutics Can Both Be Winners with their Cancer Vaccines (NWBOD, $5.50)Investment Perspective Recently Added Board Member Brings Great Expertise to the Potential Launch of APF530 (APPA, $0.64)Investment Thesis and Price Target Confidence for Success of Ofirmev Launch is Bolstered by Very Strong August Results; Buy is Reiterated (CADX; $4.07)Ofirmev Sales Are on a Strong Growth Track Hitting Major Milestones is Driving InSite's Price (INSV.OB, $0.40)Investment Summary Antares' Pipeline is Bursting with New Products; Vibex MTX is the Star (ATRS)Investment Opinion Cadence Strengthens on Positive News FlowRecent Positive News An Update on Trius Therapeutics’ Tedizolid; a Potential Blockbuster for Treating MRSA Infections (TSRX, $5.41)Investment Recommendation Johnson & Johnson: A Buy and Core Holding for the Long Haul (JNJ, $68.35)Investment Overview Cadence Pharmaceuticals: Ofirmev Launch Has Gained Traction; Reiterate BuyInvestment Overview and Opinion Bristol-Myers Squibb: Side Effect Issue with Hepatitis C Drug Creates a Buying Opportunity (BMY, $32.55)Side Effect Issue Leads to Sharp Price Drop Bristol-Myers Squibb: Best Positioned for Growth of the Four Big US Pharma CompaniesBristol-Myers (BMY), Eli Lilly (LLY), Merck (MRK) and Pfizer (PFE) were out of favor for many years based on concerns… Northwest Biotherapeutics’ DCVax Cancer Vaccines May Be a Game Changer In Cancer Therapy (NWBO, $0.22)Northwest Biotherapeutics' DC Vax Cancer Vaccine May Be a Game Changer Report Outline Spectrum Pharmaceuticals: The Bull and the Bear Case (SPPI, $15.72)Reason for Report Bristol-Myers Squibb: Acquisition of Amylin is a Mild Posiitve (BMY, $35.89)Investment Opinion A.P. Pharma: Ondansetron’s Link to QT Interval Prolongation is a Huge Positive for APF530 (APPA, $0.68)Investment Thesis Cadence Pharmaceuticals: Ofirmev Sales are Likely to Surprise on the Upside in the Second Quarter and Fears of Generic Competition are Overblown (CADX; $2.91)Investment Summary and Thesis InSite Vision: Initiation of Coverage on Promising Late Stage Ophthalmology Company (INSV, $0.30)Report Overview Discovery Laboratories: Surfaxin Is Superior to Animal Surfactants (DSCO, $2.74)
Purpose of Report Cadence Pharmaceuticals: The Ofirmev Launch Has Gained Traction (CADX, $2.72)Cadence Pharmaceuticals: The Ofirmev Launch is Gaining Traction (CADX, $xx) Trius Therapeutics' Tedizolid has Blockbuster Potential for MRSA Infections (TSRX, $5.05)Introduction Trius Therapeutics is in late stage clinical development of its new antibiotic, tedizolid, for treatment of MRSA infections that… Antares: Settlement of Litigation on EpiPen is a Positive (AIS, $3.08)Conclusion The Rationale Behind Dendritic Cell-Based Cancer Vaccines and How They are Manufactured (NWBO.OB, $0.22)Dendritic Cell-Based Cancer Vaccines Could Be a Major Advance Savient: Recommending A Switch Into Discovery Laboraratories (SVNT, $2.31)I have decided to go the sidelines on Savient (current price of $2.31) and I am recommending a switch into… A.P. Pharma: Initiating Coverage with a Buy (APPA.OB, $0.42)Key Investment Conclusions The Launch of Transcept's Intermezzo by Purdue Has Begun (TSPT, $10.92)Investment Opinion and Overview Levadex Receives Complete Response Letter, What Does This Mean for the Stock? (MAPP, $16.44)Summary Levadex Has a Good Chance for Approval on its March 26th PDUFA Date (MAPP, $17.09)Investment Opinion, In Brief There are Good Reasons to Remain Positive on Dendreon (DNDN, $11.14)When I was in high school I played the trombone in the marching band. I could never stay in step,… Generic Challenge to Pfizer's EpiPen by Teva and Antares (AIS, $2.70)EpiPen is a self-administered injection of epinephrine used to avert anaphylactic shock following a severe allergic reaction, as with a… Equity Offering Provides Discovery Laboratories Much Needed Financial Strength (DSCO, $2.81)Report Summary Surfaxin Should Be Approved on its March 6th PDUFA Date (DSCO, $2.82)Investment Thesis and Valuation Cadence: Product Recall Doesn't Alter Sales Projections (CADX, $4.19)I was somewhat alarmed to see a press release entitled “Cadence Pharmaceuticals Announces Voluntary Recall of One Lot of OFIRMEV®… Vibex MTX is the Most Exciting Component of the Antares Investment Outlook (AIS, $2.74)Investment Thesis John Johnson Resigns as CEO, After Thinking It Over, I Continue with My Buy Recommendation (SVNT, $2.27)The decision of John Johnson to go to Dendreon as CEO and Chairman after only one year at the helm… Dendreon Turns Reins Over to New CEO (DNDN, $14.18)Key Points Quarterly Sales Show That Both Provenge and Zytiga Are Doing Very Well (DNDN, $13.58)Investment Conclusion The Promise of the Antares Pipeline is the Basis of my Buy Recommendation (AIS, $2.40)Investment Opinion Expanding on Clinical Trials of CPP-109 in Cocaine Addiction and Pre-Clinical Studies of CPP-115 (CPRX, $1.14)Purpose of Report Many Investors Rate Ofirmev Launch a Failure-Not So Fast (CADX, $4.06)Investment Opinion Now That Pharmasset and Achillion Have Received Takeover Bids; Is Achillion Next? (ACHN, $9.72)Following the announcement that Gilead was proposing to acquire Pharmasset (VRUS), I postulated in a note written on November 11,… Investors' Concern About Launch of Intermezzo Weighs on the Stock and Creates a Buying Opportunity (TSPT, $8.21)Investment View Initiating Coverage Based on Interest in CPP-109 for Treating Cocaine Addiction (CPRX,$1.18)Company Overview Antares Is Initated As A Buy Based On Broad, Promising Pipeline (AIS, $2.59)Investment Opinion Initiating Coverage of MAP Pharmaceuticals with A Buy Based On Potential for Levadex (MAPP, $13.35)Investment Opinion Libi-Gel Phase III Trial Results Should Be Released Shortly (AIS, $2.73)Investment Overview Collaboration with Teva on Self-Injected Drugs Is the Major Driver of the Investment Thesis (AIS, $2.68)Investment Thesis Approval of Anturol Is Significant Positive (AIS, $2.68)Anturol Approval is A Major Positive Recently, I wrote a note about Anturol discussing its therapeutic profile and the commercialization agreement… Anturol's December 8th PDUFA Date Is Looming (AIS, $2.77)Introduction How Big is the Chronic Refractory Gout Market Addressed by Krysrexxa? (SVNT, $2.28)Introduction Initiating Coverage of Savient Pharmaceuticals with a Buy: Initial Launch of Krystexxa Has Been Disappointing but I Believe That This is a Breakrhrough Drug with Great Potential (SVNT, $2.35)Investment Opinion Are Investors So Pessimistic On Provenge That They Are Ignoring Some Positive Trends (DNDN, $8.78)Key Investment Issues Achillion Could Be On Big Pharma's Acquisition List (ACHN, $6.00)Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11… Will Inhibitex Be The Next Big Acquisition in the HCV Space ? (INHX, $10.69)Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11… Gilead Makes Bid for Pharmasset: Could Achillion Be Next in Big Pharma's Acquisition Gun Sights (ACHN, $6.00)Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11… Gilead's Acquisiton of Pharmasset Is Expensive But Great Strategic Move (GILD, $35.57)Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11… Physician Survey on Provenge is Encouraging, Upgrading Dendreon to Buy (DNDN, $6.55))Introduction Cubist Makes Attractive Takeover Bid for Adolor (ADLR, $1.91)Investment View of the Proposed Acquisition Santarus Jumps Last Hurdle for Submitting NDA on Key Blockbuster Drug Budesonide MMX (SNTS, $2.79)Investment Opinion and Overview Management Guidance On Issues Key to Provenge's Outlook (DNDN, $9.00)Investment Opinion An In-Depth Look at Santarus as it Develops a Promising Pipeline to Offset Patent Challenges to Existing Products (SNTS, $3.14)Investment Overview Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review (TSPT, $6.63)Resubmission of Intermezzo NDA Check with Adolor Management on Entereg Marketing Transition and Progress of Partnering Discussions on ADL 5945 (ADLR, $2.05)Investment Thesis Budesonide MMX's Potential in Ulcerative Colitis (SNTS, $3.18)Investment Thesis FDA Advisory Committee Recommendation for Approval of Xarelto Bodes Well for Approval of Eliquis (apixaban)The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in… FDA Advisory Committee Goes Against FDA and Recommends Approval of XareltoThe FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in… Rhucin in the Hereditary Angioedema Market Can Be A Meaningful New Product for Santarus (SNTS, $3.14)Investment Thesis Kalbitor Prospects Are Not Good in Hereditary Angioedma (DYAX, $1.61)Investment Thesis Firazyr Has Excellent Potential in the Hereditary Angioedema Market (SHPGY, $96.48)Investment Thesis ViroPharma's Cinryze is Well Positioned for Growth in the Hereditary Angioedema Market (VPHM, $18.99)Investment Thesis Xarelto's Problems are Eliquis' Opportunities (BMY. $29.90)Investment Opinion How Effective is Provenge (DNDN, $12.15)A criticism that is heard over and over from lay people is that Provenge provides only marginal benefit with an… Initiation of Coverage of ImmunoCellular Therapeutics (IMUC.OB)Investment Overview An Introduction to Sangamo's Gene Altering Technology (SGMO, $4.50)Sangamo: An Introduction to Its Gene Altering Technology Orexigen Revisited: Chances for Contrave Approval Seem Slim (OREX, $1.37)Orexigen reported second quarter results on August 8, 2011 in a press release, but did not hold a conference call.… Phase II Data for ADL 5945 in Opiod Induced Constipation is Excellent (ADLR, $2.23)On a first quick review of the data from the phase II trial of ADL 5945 in chronic non-cancer pain… Prospects for Entereg May Justify $4.50 Price Target for 2013 (ADLR, $2.20)Overview Previewing Dendreon's 2Q Results to be Reported on August 3: It's All About Provenge (DNDN, $36.13)Dendreon is scheduled to report second quarter results on August 3 and will hold a conference call at 4:30 to… New Product Potential is Outstanding But Patent Cliff is Looming (BMY, $29.28)Investment Position Eliquis Could Be A Blockbuster (BMY, $29.46)Introduction and Purpose of this Report Xarelto Could Be Another Blockbuster (JNJ, $66.64)Introduction and Purpose of this Report Second Quarter Report Was Modestly Disappointing But New Pharmaceutical Products are the Key to the Investment Outlook (JNJ, $66.26)Investment Thesis Five Questions Posed by the FDA to Its Advisory Committee on Dapagliflozin (BMY, $28.96)Overview of Five Briefing Questions Posed by FDA on Dapagliflozin Dapagliflozin's Date with the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (BMY, $29.17)Overview and Investment Thesis Intermezzo is Likely to be Approved on its July 14, 2011 PDUFA Date; Then What (TSPT, $7.98)Investment Thesis ANDA Filing Aganist Ofirmev Is Not Unduly Concerning (CADX, $9.25)Investment Opinion Provenge Receives Final CMS Reimbursement Approval (DNDN, $41.40)CMS Approval Removes Investor Concern Yervoy Was A Star at American Society of Oncology: Commercial Potential Is Enormous (BMY, $29.15)Investment Overview The Bull and Bear Case for Anadys (ANDS, $1.00)The investment thesis for Anadys is almost totally based on the prospects for its lead drug, ANA 598, which is… Upgrading to Buy Based On Regaining Glaxo's Rights in Entereg (ADLR, $1.65)Investment Thesis Implications Stemming From FDA Requirement for Extremely Large Cardiovascular Outcomes Study for Orexigen's Contrave (VVUS, $8.00)Stock Opinion Implications for Lorquess From FDA Request for Extremely Large Cardiovascular Outcomes Study for Orexigen's Contrave (ARNA, $1.31)Stock Opinion Orexigen Receives Crushing News That FDA Will Require Extremely Large Cardiovascular Outcomes Study In Order for Contrave To Gain Approval (OREX, $1.83)Stock Opinion Thoughts on Recent Poor Stock Performance (ANDS, $1.09)Meeting With CEO Steve Worland Anadys' CEO Steve Worland was in town for the Piper Jaffrey conference along with Investor Relations… Investment Negatives and Positives (ANDS, $2.06)I had a telephone conversation with CEO Steve Worland to discuss the negatives and positives for Anadys over the next… Initial Meeting with Anadys' CEO Steve Worland (ANDS, $2.33)I met with CEO Steve Worland and IR contact Amy Conrad at their offices in San Diego. This was my… Update on Anadys' Lead Drug, ANA-598 for Hepatitis C (ANDS, $2.06)I had a phone conversation with CEO Steve Worland in which he gave me an update on the company’s lead… Transcept Releases Results of Highway Driving Study for Intermezzo and Plans to Re-Submit NDA in the First Quarter of 2011 (TSPT, $6.61)Transcept believes that the results of the highway driving study of Intermezzo reasonably answer the concerns of the FDA that… Company Reports Success in Four Phase III Trials (OREX, $4.23)Orexigen has just reported success in four phase III trials for Contrave in obesity. Contrave Overview Going Over the Outlook with the New CEO, Mike Narachi (OREX, $5.32)I have met numerous times with CFO, Graham Cooper. This was an opportunity to meet with the new CEO, Michael… Thoughts on Upcoming Advisory Meeting on Contrave (OREX, $5.40)On December 3, 2010, an FDA advisory panel will review the NDA submitted by Orexigen Therapeutics for its new anti-obesity… FDA Advisory Committee Vote on Lorcaserin is Negative (ARNA, $3.74)Yesterday, the FDA advisory committee voted 9 to 5 against approval of Lorcaserin. I listened to the day long proceedings… Trying to Define Path Forward for Lorcaserin with FDA (ARNA,$1.49)Arena held a conference call on March 11, 2011 to update investors on the possible regulatory path forward for lorcaserin.… Initial Buy Recommendation (JNJ, $62.69)I believe that Johnson & Johnson will experience an acceleration in earnings based on an outstanding pipeline of new drugs.… Preview of 1Q, 2011 (DNDN, $41.78)Dendreon will be hosting its first quarter conference call on May 2, 2011 at 4:30 EST. I anticipate that Provenge… CMS May Issue Provenge Reimbursement Decision on March 31 (DNDN, $32.92)CMS may issue on March 31, its draft guidance for the national coverage analysis of Provenge for use in asymptomatic… Building a New Company on Zegerid's Ashes (SNTS, $2.24)Investors are evaluating the impact on the earnings of Santarus following the recent launch of a generic to its key… Zegerid's Patents Are Ruled Invalid (SNTS, $5.36)On April 14th, Santarus announced that a Court has ruled that five patents covering Santarus’ ZEGERID® (omeprazole/sodium bicarbonate) prescription products… Par Launches Generic Zegerid At Risk (SNTS, $4.55)Par Pharmaceutical’s launched at risk a its generic version of Zegerid capsules, Santarus responded by launching its own authorized generic,… Details on Par's Challenge to Zegerid Parents (SNTS, $3.30)Santarus has just anounced that Par has filed a paragraph IV challenge to Zegerid's patents. Depending on the outcome there… Update on Santarus (SNTS, $1.78)Overview Initiation Report (MDVN, $17.09)I am initiating coverage of Medivation based on my interest in their new drug for prostate cancer MDV 3100, which… Highlights of 1Q, 2011 (DNDN, $42.81)Summary and Stock Opinion Manufacturing and Logistics Issues (DNDN, $32.57)Dendreon intends to increase manufactruing capacity in 2011 to ten times the level of December 31, 2010. This should be… Initiating Coverage With A Buy (DNDN, $34.98)I am recommending puchase of Dendreon. The investment thesis is almost entirely dependent on the success of Provenge. Provenge's European Opportunity (DNDN, $33.59)The European Union represents a large pool of hormone resistant prostate cancer patients and could be a commercial opportunity for… Interview with Two Key Opinion Leaders In Prostate Cancer About Provenge (DNDN, $35.89)I spoke with two key opinion prostate cancer opinion leaders about their views on the potential for Dendreon's Provenge. 2011 Is The Crucial Year for Provenge and Dendreon (DNDN, $34.59)Summary and Overview Telaprevir Has Significant Therapeutic and Blockbuster Sales Potential for Hepatitis C (JNJ, $64.95)The landscape for treating hepatitis C virus is on the verge of dramatic change due to the development of new… Abiraterone is Significant Advance in Prostate Cancer Treatment (JNJ, $64.11)I recently recommended purchase of Johnson & Johnson (JNJ) in a report on April 24, 2010 called Johnson & Johnson… An Analysis of 4Q, 2010 and A Look Forward (BDSI, $3.41)BioDelivery Sciences is making steady progress in advancing its pipeline and also has set the stage for a pickup in… Initial Report (BDSI, $3.50)I have just recently begun to follow BioDelivery Sciences International (BDSI) and I am encouraged by the research that I… Initial Report (CRIS, $1.92)Summary and Overview 1Q, 2011 Overview: Ofirmev is Experiencing Exceptionally Good Formulary Acceptance (CADX, $7.72)I continue to recommend purchase of Cadence based on trends seen in the 1Q, 2011 period. The details of my… Initial Report: Ofirmev Potential is the Basis for a Buy Recommendation (CADX, $7.10)I am recommending purchase of Cadence Pharmaceuticals based on the promise of its recently launched intravenous analgesic, Ofirmev. Ipilimumab's March 26 PDUFA Date Is Looming (BMY, $26.00)The PDUFA date for ipilimumab is coming up on March 26th. This is an important component of BMY's outstanding pipeline.… Ipilimumab's Approved Indications Exceed Expectations (BMY, $26.93)I was expecting approval of ipilimumab for patients who had failed prior therapy. I was surprised that the FDA also… Initiating With Buy: Weighing an Excellent New Product Outlook Against the Pending Patent Cliff (BMY, $25I think that Bristol-Myers Squibb has one of the most attractive drug pipelines of the big pharma companies. Although it… Initiation Report on a Cheap Lumbering Stock (PFE, $20.78)Pfizer is entering a patent cliff period in which sales will decline over the next two years. The drug pipleline… Onsite Meeting with Anadys' CEO Steve Worland (ANDS, $1.77)I met with Anadys’ CEO Steve Worland and IR contact Amy Conrad at their offices in San Diego for an… Analysis of Adolor's 1Q, 2011 and A Look Forward (ADLR, $1.39)Entereg Results in the Quarter Were Excellent Initial Report on Adolor (ADLR, $1.38)Adolor as a Stock While I am currently neutral on Adolor, it is a stock that I am watching closely. To… Hopes for Rivaroxaban Are Dashed (JNJ, $65.00)Investment Opinion For Yearly-Access Subscribers OnlyRestricted Report Content… For Monthly-Access Subscribers OnlyRestricted Report Content… |
