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.… Northwest Biotherapeutics: Comments on FDA Guidance for Use of Contemporaneous External Controls; Importance for DCVax-LThe FDA just issued new guidance on the use of contemporaneous external controls in clinical trials. Hedge funds who are… 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; JAMA Oncology A Publication Journal of the American Medical Association Publishes Peer Reviewed Article on DCVax-L (murcidencel).Overview This article puts into perspective the importance of a peer reviewed article on the Phase 3 Trial of murcidencel (better… 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… Cryoport: Strength in StockThe meaningful increase in today's price appears to be due to the reported approval of Gilead's CAR-T drug Yescarta in… Could There Have Been Hundreds of Millions or Even More Than a Billion Counterfeit Shares of Northwest Biotherapeutics Created Through Illegal Naked Shorting?I am often asked how I can hypothesize that there may be such an unbelievably large number of counterfeit shares… Encouraging Comments on DCVax-L from a Key Opinion LeaderIf you haven't already seen it, there is video posted on You Tube in which a key opinion leader (KOL)… 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… Are There Implications from the Frenzy over GameStop for Adam FeuersteinThe media focus on corrupt hedge fund short selling has not surprisingly turned to bloggers who are closely associated with… Wall Street is Poised for Disruption, Part 2, February 1, 2021The Current Media Narrative That Retail Investors Trading on Robinhood Were Primarily Responsible for the GameStop Short Squeeze Appears False.… Wall Street is Poised for Disruption, Part One January 30, 2021It is Time for Wall Street Wall Street Business Practices to Be Disrupted The frenzy of news flow around the short… Northwest Biotherapeutics and the Robinhood Trading Phenomenon (NWBO), Buy, $1.59)Stunning Stock Price Movements for GameStop and AMC Entertainment There has been a lot of news coverage this week about the… 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… Mesoblast, Athersys, Cryoport, ARDS and COVID-19.Today’s issue of the Wall Street Journal carries an opinion piece entitled “The Treatment That Could Crush Covid”. The article… 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… An Overview of Companies with a Major Presence in CAR-T ResearchInvestment Opportunity One of the areas that I want to focus my investment research on is CAR-T therapy. I believe… Looking at Market Capitalizations as an Investment Tool for Biopharma CompaniesPurpose of Report This report looks at the market capitalizations of 6 big pharma companies, 14 large biotechs, 24 mid-size commercial… A New Note on Cytokinetics with a Focus on OmecamtivCytokinetics and its partner Amgen have guided that topline data from the GALACTIC-HF phase 3 trial of omecamtiv in advanced… 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… Stem Cell Therapy Has Perhaps the Most Potential of All of the New Technologies in Development by BiopharmaSummary In previous articles, I have written about technologies that have been or promise to be paradigm shifts in drug… Gene Therapy Will Be A Major Driver of Biopharma Growth in Coming DecadesOverview This is the fourth in a series of articles intended to give a layman’s view of the technologies that are… RNA Interference is in its Infancy, But Promises to Generate Innumerable Blockbuster Drugs in Coming DecadesIntroduction This is the third of five reports that are intended to give a layman’s overview, first of two technologies that… Monoclonal Antibodies: The Driving Force Behind Today’s Biopharma IndustryIntroduction This is the second of five reports that are intended to give a layman’s overview, first of two technologies that… 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… Cryoport: (CYRX, $20.10, Buy) Announcement of Potential Convertible Offering Pressures the StockCryoport’s stock at the time of the writing of this note has traded down $5.19 or 20% following the announcement… 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… Recombinant DNA: The Foundation Upon which the Biotechnology industry was FoundedIntroduction As I previewed in Announcing A Strategic Change in Coverage Approach at SmithOnStocks , I am taking a new approach… 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… Announcing A Strategic Change in Coverage Approach at SmithOnStocksSmithOnStocks Research Approach is Changing I am altering the way I do research and then publish articles on SmithOnStocks. My prior… 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… 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: A More Thorough Discussion of the Potential Survival Tail of DCVax-L in Newly Diagnosed GBM than Originally Presented in My September 17, 2019 Report (NWBO, Buy, $0.25)Reason for This Further Discussion A number of subscribers have pointed out to me that my discussion of the survival tail… 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… Cryoport; Sales of CAR-T Products Yescarta and Kymriah are In-line with My Projections (CYRX, Buy, $20.67)Cryoport will report 2Q, 2019 results on August 8, 2019 at 5:00 PM EST. One area of keen interest for… Part 10 of Illegal Naked Shorting Series: Legal Shorting of Stocks is a Loser’s Game but Illegal Naked Shorting Transforms It into a Winner’s GameUpfront Caveat When I launched my research on stock manipulation and the prominent role played by illegal naked shorting, I believed… Part 9 of Illegal Naked Shorting Series: The Risk/ Reward of Shorting Versus Buying Stocks is Extremely UnfavorableInvestment Overview Selling something you don’t own seems a pretty alien concept to me. I struggle to find any business models… 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… Part 8: Illegal Naked Shorting Series: Who or What is Cede and What Role Does Cede Play in the Trading of Stocks?You Really Don’t Own the Shares that Appear in Your Brokerage Account; They Belong to Cede Most investors when they buy… 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… Part 7: Illegal Naked Shorting: DTCC Continuous Net Settlement and Stock Borrowing Programs Have Loopholes That Facilitate Illegal Naked ShortingAcronyms Used Frequently in This Report DTCC: The Depository Trust & Clearing Corporation (DTCC) provides clearing and settlement services to the… Part 6 Illegal Naked Shorting: The SEC’s Regulation SHO is Intended to Prevent Illegal Naked Shorting, But is IneffectiveOverview In previous blogs I traced the history of stock trading from the 1960s when stock certificates and cash were physically… 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 Ondexxya Receives Conditional EU Approval as Expected (PTLA, Buy, $36.44)Portola Pharmaceuticals announced last Friday that the European Commission granted conditional Marketing Authorization for Ondexxya (andexanet alfa). In the US,… 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… Part 4 in Series on Illegal Naked Shorting’s Role in Stock Manipulation: Who are the Key Players?Introduction I worked on Wall Street as an analyst for nearly 40 years and was involved in the stock market on… Part 3 in Series on Illegal Naked Shorting’s Role in Stock Manipulation – Prime Brokers and the DTCC Have a Troubling Monopoly on Clearing and Settling Stock TradesClearing and Settling of Stock Trades Most of us when we enter a buy or sell order for a stock give… 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… Comment on the Sharp Correction in Small Biopharma Stocks
Let me say a word about the stock market and the small biopharma 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… Brief Updates on Key Buy RecommendationsFor personal reasons, I am going to be unavailable until October 29. During this interval of silence, there may be… 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: Critical Upcoming Catalysts Have the Potential to Cause a Sharp Upward Move in the Stock (PTLA, Buy, $29.19)Investor focus is totally on Andexxa at this point in time as the disappointing 2Q, 2018 sales results for Bevyxxa… 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… Update on Currently Recommended Stocks of SmithOnStocks.comReport Overview I periodically update my recommendations and that is the objective of this report. I also spend some time on… 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.… Novartis Releases Three Month Interim Data for JULIET Trial of CTL-019 in r/r DLBCLKey Points: Comparison of three month data for CTL-019 in the JULIET trial with Axi-Cel in ZUMA-1 indicates that safety… FDA Announces July 12 AdCom Meeting for CTL-019: Thoughts on How This Might Affect Investor Perceptions of Kite (KITE, Neutral, $80.25) and Cryoport (CYRX, Buy, $3.89)The FDA has announced that there will be an AdCom meeting for Novartis’ CTL-019 for the treatment of pediatric r/r… Northwest Biotheraputics to Make Presentation at ASCO Today Monday June 5, 2017Northwest issued a press release announcing a presentation at ASCO today by the Company’s Chief Technical Officer, Dr. Marnix Bosch.… Key Investment Considerations Relating to Much Anticipated CAR-T Product Launches By Kite and Novartis Later This YearInvestment Conclusions: Cryoport: My recommended best way to invest in CAR-T launches (CYRX, Buy, $3.60) 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… Cytokinetics: Comments on the Upside Move Today (CYTK, Buy, $12.90)Cytokinetics is up $1.15 or 10% to $12.90 in a poor market environment. The only news is that the Company… 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… 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… SmithOnStocks Investment Recommendations Summarized; September 12, 2016PURPOSE OF REPORT Biotechnology investing is characterized by long periods of steady, sometimes frightening declines followed by periods of euphoria. We… 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… Bristol-Myers Squibb: Checkmate-026 Trial Fails to Reach Primary Endpoint (BMY, $62.85); A Buying OpportunityPerspective Bristol-Myers Squibb Company announced today that Opdivo had failed to reach its primary endpoint of progression free survival in the… 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,… Updates on My Investment Opinion for 15 Stocks I Follow CloselyReport Overview This blog gives a quick update on my thinking on the 15 stocks which I cover. In most cases,… 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… Northwest Biotherapeutics (NWBO): Some Thoughts about the Appointment of Two New Board MembersPurpose of the Report Northwest Biotherapeutics announced on January 25 that it is adding two new members to its current… My Current Thoughts on 13 Stocks I Cover and the Investment Outlook for the MarketPurpose of This Report 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… 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… |
