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… 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… Antares Pharma: Acquisition by HalozymeI am a little sad to see Antares sell out to Halozyme. I thought that the rubber was just starting… Northwest BiotherapeuticsI am in the late stages of completing an update on NWBO. It should be out soon.… 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)… What Will Happen to SmithOnStocksI want to thank people who expressed their appreciation for my research over the years upon learning that I was… Closing Subscriptions to SmithOnStocks and Issuing RefundsI have decided to close the subscription service to SmithOnStocks and will refund subscriptions paid over the past year per… 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… 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… 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… 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… 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… 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… 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… Regeneron’s Kevzara May be Able to Reduce Deaths from COVID-19 Infections Now!!Why Kevzara Might Reduce Deaths from COVID-19 Kevzara (sarilumab) was developed by Regeneron and Sanofi as a human monoclonal antibody against… 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… 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… 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… 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… 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… Part 5 in Series on Illegal Naked Shorting’s Role in Stock Manipulation: Traditional Shorting Compared to Naked Shorting (Both Legal and Illegal)Introduction This is the fifth blog in the series that I am writing to describe how illegal naked shorting is used… 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,… 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… Part 2 in Series on Illegal Naked Shorting’s Role in Stock Manipulation- Conventional Wisdom on How Short Sales are ExecutedIntroduction The current conventional wisdom on how a short sale is transacted is that a short seller borrows stock from a… Part 1 in a Series of Reports on Blatant, Widespread Stock Manipulation that is Enabled by Illegal, Naked ShortingIs There a Way for Companies to Fight Back? Yes!!!!!! I am convinced that price manipulation by Wall Street bad actors… Today's Price Action in Cytokinetics (CYTK) and Cryoport (CYRX)
There has been strong price action today in both Cryoport Comment on the Sharp Correction in Small Biopharma Stocks
Let me say a word about the stock market and the small biopharma 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… 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… 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… 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) 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… 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… 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… 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… 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… 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… 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,… 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 Martin Shkreli Arrested; This Could Be A Major Catalyst for Small Biotechnology StocksBloomberg reported that Martin Shkreli was arrested at his home this morning (December 17) on charges of securities fraud; his lawyer… Why Biotechnology Investing is So Difficult: Cytokinetics is a Case Study (free article)Overview I just finished publishing a detailed article for subscribers to my website detailing my view that Cytokinetics offers asymmetric upside potential.… KaloBios: The Fascinating Story of the Takeover of the Company by Martin Shkreli and His Hedge Fund Buddies (KBIO, $18.25, I would not touch this stock)Investment Thesis and Overview KaloBios (KBIO) announced on November 13 that it was ceasing operations and had engaged a restructuring firm… Valeant Pharmaceuticals: What A Sordid Story (VRX, $93.77)My View on Valeant I have been asked about my feelings on Valeant. I would start out by saying that I… Review of SmithOnStocks Recommendations; August 17, 2015Purpose of Report I am leaving on vacation and will be back on August 27, 2015; you won’t hear from me… Comments on Agenus, ImmunoCellular, Discovery Laboratories, Neuralstem, Kite and JunoSmithOnStocks Mailbox My mailbox comments are brief notes on stocks… Implication of the Juno Celgene Deal for Emerging Immuno-Oncology Biotechnology Stocks in General and Northwest Biotherapeutics in ParticularThe Terms of the Juno Celgene Deal Celgene and Juno announced a ten year collaboration for drug development using CAR-T therapy… Illegal Naked Short Selling Appears to Lie at the Heart of an Extensive Stock Manipulation SchemeInvestment Consequences of Naked Shorting Only a motivated enforcement agency with subpoena power and an accompanying powerful enforcement infrastructure can prove… Comments on Agenus and AntaresSmithOnStocks Mailbox My mailbox comments are brief articles on stocks in which I am involved. These can come from… Comments on Antares, Kite Pharma and Northwest BiotherapeuticsSmithOnStocks Mailbox My mailbox comments are brief articles on stocks in which I am involved. These can come from… Comments on Agenus, Neuralstem and CelldexSmithOnStocks Mailbox 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… Comments on Antares, Agenus, Cytokinetics, Discovery Laboratories and ZS PharmaSmithOnStocks Mailbox Effective Treatment of Hyperkalemia Promises to be a Multi-billion OpportunityKey Points There are no effective treatment options for long term treatment of hyperkalemia (high potassium levels). Some Observations on Northwest Biotherapeutics (NWBO), Neuralstem (CUR), Cytokinetics (CYTK) and Immuno-Cellular (IMUC) from Their Presentations at BIO CEO.The BIO CEO Conference is being held in New York at the Waldorf Astoria on February 9 and 10 with… SmithOnStocks Mailbox, January 31 Edition: My Take on News Events Relating to Companies I FollowIntroduction A number of subscribers have suggested that I write more on recent news events that relate to companies that I… Advaxis: A Look at the Dizzying Trading Activity over the Past Month (ADXS, No opinion, $9.70)Introduction My approach to my website in the two years I have been publishing is to in-depth research on a limited… Northwest Biotherapeutics: Some Thoughts about the Upcoming Presentation by CEO Linda Powers on Monday, January 26th. (NWBO, Buy, $6.28)
Ms. Powers will present at 10:30 AM. Immuno-Oncology Promises to be the Next “Big Thing” In BiotechnologyImmuno-Oncology Promises to be the Next “Big Thing” In Biotechnology Immuno-oncology has been the hottest area in biotechnology… Antares Pharmaceuticals: Highlights of Presentation at JP Morgan Conference (ATRS, $2.36. Buy)Investment Overview Antares has hit a somewhat dis-settling stretch as Otrexup prescriptions have recently flattened and the FDA recommended that additional… Notes from Neuralstem Presentation at Biotech Showcase Conference, January 13, 2015 (CUR, Buy, $3.09)Richard Gar, CEO of Neuralstem (CUR), made a presentation at Biotech Showcase Conference in San Francisco on January 13, 2015.… Delay in Quick Shot Testosterone Clinical Program is Not a Major Setback for the Stock (ATRS, Buy, $2.53)Antares sent out a press release today about a new development in the Quick Shot Testosterone phase 3 program. The Company… 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… Repligen: Revenues for 2014 are Above Expectations and Guidance for 2015 is for Strong Growth (RGEN, Hold/ Buy, $23.84)Repligen reported preliminary, unaudited revenue of $63-$63.5 million for 2014. Product revenues came in at $60 to $60.5 million which… Neuralstem: An Update on Potential Catalysts for 2015 (CUR, Buy, 3.38)Overview and Investment Thinking I wrote a report on Neuralstem on August 26, 2014 in which I projected the timing of important… Cytokinetics: Takeaways from January 5, 2014 Conference Call (CYTK, Buy, $7.82)Cytokinetics held a conference call on January 5th in which they added some detail on the collaboration with Astellas on… Cytokinetics: With the Stock Up 63% in the Last Seven Trading Days, What Do We Do Now? (CYTK, $8.01, Buy)
The strength followed the announcement of a new collaboration agreement with Astellas on CYTK’s unique skeletal muscle activators program Current Investment Recommendations for Stocks Covered by SmithOnStocks; A Yearend ReviewOverview This has been a tough year for many small emerging biotechnology firms. Many have been in a bear market while… Neuralstem: Some Encouraging, But Very Early, Information on Chinese Ischemic Stroke Trial Using NSI-566 Stem Cells (CUR, Buy, $2.59)Purpose of This Blog I received this e-mail communication from a SmithOnStocks subscriber who has a good insight into the Chinese… Antares: Responding to Two Questions on Teva’s AB Rated Competitor to EpiPen (ATRS, Buy, $2.44)Purpose of the Blog I very much appreciate questions and feedback from subscribers to my website. I have had two recent… Antares: Highlights of CEO’s Presentation at Piper Jaffray Conference (ATRS, Buy, $2.46)Overview I tuned in to the Antares presentation at the Piper Jaffrey conference on December 2, 2014 to listen to what… 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… 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… Weakness in Neuralstem Caused by Seeking Alpha Article Presents a Buying Opportunity (CUR, $2.69, Buy)
This is an updated version of a blog that was published on October 20th. Cytokinetics Is Planning for a Phase 3 Trial in 2015 for Tirasemtiv in ALS (CYTK, $3.26, Buy)Cytokinetics (CYTK) has announced that it is planning a phase 3 trial for tirasemtiv using sustained vital capacity-SVC- as… Discovery Laboratories Has Formed an Important Collaboration with Battelle to Develop Aerosurf (DSCO, Buy, $1.69)
This agreement partners Discovery with a world class medical device developer and meaningfully de-risks development of Aerosurf. Trying To Find Those Technologies and Emerging Biotechnology Companies That Could Be The Big Winners of Coming Decades My Dialogue with Adam Feuerstein on Northwest BiotherapeuticsPerspective Neuralstem: Investigators are Very Positive on NSI-566 Results in ALS (CUR, Buy, $3.27)Investment Perspective The key investigators for the treatment of ALS with Neuralstem’s NSI-566 neural stem cells have been extremely positive in… Derma Sciences: Second Quarter Results Were Disappointing; Going From a Buy to a Hold (DSCI, $9.72)Derma Sciences released second quarter results this morning and this is my quick take. I will have a more detailed… My Rebuttal to Richard Pearson's Attack Article on Me Is Now On Seeking AlphaAfter a week of effort in trying to post a rebuttal to Richard Pearson's attack article on me, I finally… Northwest Biotherapeutics (NWBO, Buy $6.75): Responding to Serious Unsubstantiated Allegations by Richard PearsonWho Is Richard Pearson? On July 7, I was the subject of a vicious and libelous article that was published on… Cytokinetics: Tirasemtiv May Still Be Successfully Developed in ALS (CYTK, Buy, $4.77)I think that there is a strong possibility that Cytokinetics (to the surprise of Wall Street) could announce sometime in… Antares: More On Paul Wotton’s Departures as CEO (ATRS, Buy, $2.77)This is a follow-up on Paul Wotton’s decision to leave his position as CEO of Antares (ATRS) to become CEO… Antares: Thoughts on the Resignation of the CEO (ATRS, $2.76, Buy)The resignation of Paul Wotton as CEO of Antares came as a surprise to me and I think most other… Northwest Biotherapeutics: Sixteenth Feuerstein Attack on the Company (NWBO, Buy, $8.11)Adam Feuerstein has just launched its 16th negative blog on Northwest Biotherapeutics since the beginning of March and this has… Neuralstem: Encouraging Phase 1b Data on NSI-189 (CUR, Buy, $4.35, Free content)On June 17 at the American Society of Clinical Psychopharmacology Neuralstem reported phase 1b data for its small molecule drug… Northwest Biotherapeutics: The Perfect Storm May Be Brewing for Short Sellers (NWBO, $7.66, Buy, Free Content)I wrote on June 12th that NWBO stockholders may be seeing a changing in the tide of investor opinion. The… Discovery Laboratories: A Look at the Surfaxin Launch and the Phase 2a Trial of Aerosurf (DSCO, Buy, $1.79, free content)Launch of Surfaxin The launch of Surfaxin has begun and initial results were below expectations causing the Company a few months… Northwest Biotherapeutics to Host Conference Call This Afternoon, May 27th (NWBO, Buy, $6.25)
Northwest Biotherapeutics announced today that the Company will host a conference call and webcast with CEO Linda Powers today, May… Northwest Biotherapeutics Releases Promising Early Results in DCVax Direct Phase 1 Trial (NWBO, $6.20, content of this note is not limited to subscribers)Overview Northwest Biotherapeutics told investors that it would discuss initial results of the phase 1/2 trial of DCVax-Direct in inoperable solid… Northwest Biotherapeutics: Update On DCVax-Direct Based on ASCO Abstract and Positive, Early Results for First Patient Reported On (NWBO, Buy, and $5.94)Investment Conclusion The ASCO abstract on DCVax-Direct was released last night. It contains only a description of the drug and the… ImmunoCellular Therapeutics: Comments on ASCO Abstract on ICT-107 (IMUC, Trading Buy, $1.20)Investment Overview The abstract on ICT-107 was released last night and is just a brief summary of the trial results as… Cytokinetics: There Yet May Be a Path Forward to Develop Tirasemtiv in ALS (CYTK, Buy, $4.49, Paid Subscribers)Overview Cytokinetics held a conference call on the results of the BENEFIT-ALS trial on the morning of April 30. The Company… Cytokinetics Announces that Tirasemtiv Phase 2b Trial in ALS Failed (CYTK, Buy, $5.01)Cytokinetics announced that tirasemtiv failed to reach the primary endpoint in the phase 2b BENEFIT-ALS trial in ALS. The mean… ImmunoCellular Therapeutics Trading Opportunity (IMUC, Not rated, $1.19, Paid Subscribers)ImmunoCellular Therapeutics just announced that an abstract describing the phase II trial of its dendritic cell-based cancer vaccine ICT-107 in… Thoughts on the Market Correction in Biotechnology StocksThis Has Been a Tough Correction The recent sharp market correction and rotation out of growth stocks like biotechnology and technology… Northwest Biotherapeutics: Just Announced Financing Signals High Expectations for Use of DCVax-L under German Hospital Exemption Program (NWBO, $6.75, Paid Subscribers)Purpose of New Financing Northwest Biotherapeutics just announced a financing in which a single institutional investor bought $15 million of stock… Cytokinetics: The Critical Phase 2b Results for Tirasemtiv Should be Released on April 29th (CYTK, $8.88, Buy, Paid Subscribers Only)Phase 2b Data on Tirasemtiv will be Presented on April 29th Cytokinetics has an extremely important binary event upcoming as the… Refuting Feuerstein’s Latest Negative Blog on Northwest Biotherapeutics (NWBO, Buy, $7.56)Before I Get Into This Article, a Word to My Subscribers I want to apologize to my subscribers for a software… Northwest Biotherapeutics (NWBO, Buy, $7.59) What the 2014 10-K Had to Say about the Approval of DCVax-L under the German Early Access ProgramPurpose of This Blog The approval of DCVax-L under the hospital exemption early access program was a stunning positive in my… My Investment Thinking on Biotechnology Stocks in the Aftermath of the Recent CorrectionIntroduction The biotechnology stocks have gone through a correction over the last few days that has shaken investor confidence. Traders are… Some Thoughts on Short Selling of Biotechnology Stocks (Paid Subscribers)I am a fundamentalist and am long term oriented. However, there is a darker side to the market that requires… Northwest Biotherapeutics (NWBO, Buy, $7.90): DCVax-L Is Approved in Germany under Hospital Exemption Early Access ProgramIntroduction Please read this report very carefully. This is the first time that any systemic drug has been approved under the… Northwest Biotherapeutics (NWBO, $6.06, Buy): Comments on First Interim Look at DCVax-L Trial and Recent Weakness in the StockReason for Stock Weakness The stock of Northwest Biotherapeutics (NWBO) has been under pressure that appears largely to have been caused… Current Recommended Stocks and an Analysis of Past Recommendations, March 5, 2014)Current Recommended Stocks I only started offering research on my website on a subscription basis in early December, 2013 so that… SmithOnStocks Mailbox February 25, 2014I have found that there are some very smart people out there who have interesting questions and perspectives concerning my… Cytokinetics: Institutional Investors Give BENEFIT-ALS Potential Results a Vote of Confidence (CYTK, $9.06)Cytokinetics (CYTK) announced that it has completed an equity offering in which it issued 4.375 million shares at a price… Cadence: A Post Mortem on a Successful Investment and What to Do with the Proceeds (CADX, $14.00)Mallinckrodt (MNK) announced that one of its subsidiaries will start a tender offer to acquire all of the outstanding shares… Cadence: Patent Settlement With Sandoz Increases Confidence That Ofirmev Will Have Exclusivity Through December 6, 2020 (CADX, $10.98)On January 30, 2014, Cadence (CADX) announced that it had entered into a settlement agreement with Sandoz to resolve pending… SmithOnStocks Mailbox January 28, 2014In my writing, I have found that there are some very smart people out there who have interesting questions and… Agenda for BIO CEO ConferenceI will be attending the annual BIO CEO Conference in New York on February 10 and 11. I have included… Agenus: Key Opinion Leader Support Builds for Prophage (AGEN, $3.27)Can Cancer Vaccines Work? The issue of whether cancer vaccines are viable therapeutic candidates has been hotly debated by investors. A… Thoughts on the Price Surge of Cytokinetics (CYTK, $8.75)Cytokinetics has been on a tear this year. Is started the year at $6.72 and closed yesterday (January 10) at… If You’re Going to San FranciscoThis has always been one of my favorite songs and I love the lyrics. If you're going to San Francisco A Trading Call on a Stock That I Like for the Long TermI want to bring to the attention of paid subscribers to my website an idea that is essentially a trading… Adam Feuerstein’s Views on Northwest Biotherapeutics (NWBO, $3.37)Adam Feuerstein has consistently disagreed with authors who believe that there is a sound basis for Northwest Biotherapeutics (NWBO) conducting… Northwest Biotherapeutics: An Analysis of Its Transforming Balance Sheet Restructuring (NWBO, $4.14)Key Takeaway Points of this Report What SmithOnStocks Is All AboutWelcome to SmithOnStocks I want to welcome newsubscribers to my website. SmithOnStocks.com has been a process two years in the making… Discovery Laboratories: An Asymmetric Opportunity (DSCO, $2.07)I have just published the first of a series of reports on Discovery Laboratories. Cadence: Best Case Outcome on Ofirmev Patent Litigation (CADX, $7.88)Patent Litigation on Ofirmev Antares Marketing Agreement on Otrexup with Leo is a Nice Positive (ATRS, $3.93)Antares is preparing to launch Otrexup for rheumatoid arthritis in the US in late January of 2014 with its own… Discovery Laboratories: Removal of Financing Overhang Is a Catalyst for the Stock (DSCO, $2.17)Investment Thesis ImmunoCellular Thoughts on Potential Outcomes for the Phase II Trial of ICT-107 in Newly Diagnosed Glioblastoma (IMUC, $2.31) (Subscribers Only)Investment Viewpoint Antares: Thoughts on the Upcoming Otrexup Launch (ATRS, $3.64)Investment Thesis Cadence Pharmaceuticals: The Ofirmev Launch is a Spectacular Success, but Investors are Focused on Patent Litigation (CADX, $4.99)Investment Thesis Celldex (CLDX, $23.06): Previewing the Imminent Data Release on RindopepimutNote: Comprehensive reports are now available to paid subscribers and can be found in the Reports section. Investment Background and Thesis Cytokinetics: 2014 Will Bring Critical Data Readouts on Tirasemtiv and Omecamtiv Mecarbil (CYTK, $6.03)Key Takeaways From 3Q, 2013 Conference Call Celldex: Why Investors Are So Excited About the Company (CLDX, Hold, $24.39)This post is an excerpt from the report: Celldex: Pipeline Promise Has Been Embraced by Wall Street Comprehensive reports are now available… pSivida: Thoughts on pSivida in the Aftermath of the Complete Response Letter on Iluvien (PSDV, $2.87)Background on the Complete Response Letter Cytokinetics: Previewing the Release of Data from the ATOMIC-AHF Trial of Omecamtiv Mecarbil (CYTK, $9.95)Investment Overview In my last note, I wrote that I thought the ATOMIC-AHF, phase IIb trial of the intravenous dosage form… Cadence: Comments on Patent Office Re-examination of Key Cadence PatentCadence (CADX) announced that the US patent office has issued an initial action on the re-examination of one of two… Cadence: Ofirmev Sales Are Extremely Strong; Ofirmev Patent Decision Could Come by Yearend (CADX, $6.80)Investment Thesis Trius: Will there be a Higher Bidder and what is the CVR Worth? (TSRX; $14.10)What is the CVR Worth? InSite Vision: DOUBle Trial Results are Disappointing-What Comes Next? (INSV.OB, $0.33)Summary and Investment Thesis Cytokinetics: Another Positive Deal for Shareholders, This Time with Astellas (CYTK, $11.81)Cytokinetics (CYTK) has completed its second meaningful deal in two weeks. Today they announced a deal with Astellas (ALPMY) and… Cytokinetics (CYTK, $1.40) Receives a Vote of Confidence from AmgenCytokinetics (CYTK) has announced an expansion of the partnering agreement with Amgen (AMGN) for omecamtiv mecarbil, the Company’s lead product… Northwest Biotherapeutics ($3.44): M.D. Anderson’s Lead Role in DCVax Direct Trial is EncouragingNorthwest Biotherapeutics (NWBO) announced today that the phase I/II trial of DCVax Direct has been initiated at M.D. Anderson Cancer… Thoughts on the Growing Crisis of Bacterial Resistance to AntibioticsInvestment Overview SmithOnStocks Opines on Biotechnology Stocks, June 10, 2013Introduction SmithOnStocks Opines on Biotechnology Stocks, June 2, 2013Overview of This Week's Report SmithOnStocks Opines on Biotechnology Stocks, May 28, 2013Introduction Neuralstem: Update on Phase I Trial of Neural Stem Cells in ALS is Encouraging (CUR, $1.45)Purpose of Report SmithOnStocks Opines on Stocks May 19, EditionOne Approach for Investing in Emerging Biotechnology Stocks Antares: Reiteration of My Buy Recommendation (ATRS, $4.00)Investment Thesis Neuralstem: Update on ALS Trial Could be a Catalyst for the Stock (CUR, $1.30)Key Investment Summary Trius Therapeutics: Newly Allowed Patent Provides Important New Dimension to Investment Outlook (TSRX, $8.50)Investment Thesis Trius announced an important new development today that bolsters my investment case for Trius (TSRX) and I continue with… SmithOnStocks Opines on Recent Biotech EventsIntroduction ImmunoCellular Therapeutics: Marching Toward Top Line Data for ICT-107 in 4Q, 2013 (IMUC, $2.42)Introduction InSite Vision: An Over-looked Company with Two Interesting Drug Candidates and a Big Upcoming Catalyst (INSV.OB, $0.31)Results of the Important DOUBle Trial Are Imminent Transcept: Throwing in the Towel on Intermezzo (TSPT, $3.59)Intermezzo was launched by Transcept’s marketing partner Purdue in April 2012. I believed then and now that it is a… Cadence Pharmaceuticals: Ofirmev Launch is Strong; Resolution of Patent Issues Could Be Soon (CADX, $6.86)Investment Thesis A.P. Pharma: Management Change is a Positive for the Stock (APPA.OB, $0.39)Introduction Discovery Laboratories: Still Another Delay in the Surfaxin Launch (DSCO, $2.00)Overview Cytokinetics: Key Issues for Beginning Phase III for Omecamtiv Mecarbil in Congestive Heart Failure (CYTK, $1.15)Overview and Investment Importance Trius: Clinical Trials Show Important Differentiation of Tedizolid from Zyvox (TSRX, $6.48)Investment Summary and Opinion Besivance Royalty Deal Extends InSite’s Cash Runway (INSV.OB, $0.31)InSite Vision(INSV.OB) announced that it agreed to sell its royalty stream on future sales of Besivance, a product that is… A.P. Pharma Receives Complete Response Letter on APF530 (APPA.OB, $0.34)Overview Investment Implications of the Acquisition of MAP Pharmaceuticals by AllerganAllergan to Acquire MAP Pharmaceuticals Cadence: Management Guides to a Near Doubling of Ofirmev Sales in 2013 (CADX, $5.23)My confidence in my long standing Buy recommendation on Cadence (CADX) has been strengthened by its pre-announcement that 4Q, 2012… InSite Vision: Upcoming Results on the DOUBle Trial May Not Be as Binary as I Have Been ThinkingI met with the CEO, Tim Ruane, and CFO, Lou Drapeau, of InSite Vision (INSV.OB) in early January during my… Discovery Laboratories Announces Changing of the Guard (DSCO, $2.21)New Board and New CEO Transcept: Direct to Consumer Advertising Campaign Could be the Tipping Point for IntermezzoInvestment Overview The launch of Intermezzo began on April 4, 2012 and so far, it has been disappointing for investors. Purdue… My Buy Rating on Cadence Pharmaceticals is Bolstered by Ofirmev Patent Settlement with PerrigoInvestment Conclusion Initiation of Coverage on NovaBay with a BuyIntroduction I have just written a new report on NovaBay (NBY) called NovaBay’s Robust Clinical Pipeline Approaches Critical Clinical Trial Results… Northwest Biotherapeutics Stock Surges 94% on Perfect Storm Created by Short Squeeze and New Buying Interest (NWBOD, $10.75)Investment Summary Thoughts on Northwest Biotherapeutics’ Reverse Stock SplitNorthwest Biotherapeutics (NWBO.OB) announced a 1 for 16 reverse stock split. This is a first step in a planned public… Discovery Laboratories: The Street Is Getting on Board With MeMy Recent History on Discovery Laboratories On February 22, 2012, I initiated coverage of Discover Laboratories with a Buy and at… Manish Singh Resigns as CEO of ImmunoCellular Therapeutics: Implications for Northwest Biotherapeutics and ImmunoCellularImmunoCellular (IMUC.OB) has issued a press release stating that Manish Singh has resigned as CEO. He will be succeeded in… Johnson & Johnson: A Core Holding for the Long Haul
I have just written a report on JNJ in which I reiterated my Buy recommendation. I don’t see a vibrant… Cadence Pharmaceuticals Ofirmev Has Gained Traction Producing Upside Surprise in 2Q, 2012I reiterate my Buy recommendation on Cadence. The Ofirmev launch has now gained traction as just reported 2Q, 2012 revenues… Spectrum Pharmaceuticals: Fusilev Has Explosive Month in JuneIn my recent article Spectrum Pharmaceuticals: The Bull and the Bear Case, I wrote about the tug of war between… Northwest Biotherapeutics' DC Vax Cancer Vaccine May Be a Game Changer In Cancer
I am starting my coverage of Northwest Biotherapeutics (NWBO.OB) with a Buy. I became interested in this small bulletin board… Spectrum Pharmaceuticals: The Bear and Bull CaseAt the request of some subscribers to my website, I have been asked to take a look at the bull… Issuance of Complete Response Letter for Eliquis Doesn’t Alter My Buy on Bristol-Myers SquibbInvestment Opinion I believe that the issuance of a Complete Response Letter to Bristol-Myers Squibb (BMY) and Pfizer (PFE) for the… InSite Vision: Initiating Coverage on a Promising Company with a Robust Late Stage Product PortfolioI have just published a new report and initiated coverage of InSite Vision (INSV, $0.30) with a Buy. The core… Initiating Coverage of A.P. Pharma with a Buy (APPA, $0.42)I have just published a report initiating coverage on A.P. Pharma (APPA, $0.42) in which I recommend purchase; my 2015… Dendreon Turns Reins Over to New CEOKey Points Dendreon has made a sweeping change in management by bringing in John Johnson, who was serving as a board… New Scientific Abstact Suggests That Median Overall Survival for Provenge is 7.8 Months, Not 4.1 (DNDN, $14.09)Conclusions Johnson & Johnson's Turnaround Led by New Drug Products is Underway (JNJ, $65.15)
Investment Conclusion Investors' Concerns About the Intermezzo Launch Weighs on the Stock and Creates a Buying OpportunityInvestment View I believe that Transcept’s (TSPT) Intermezzo is an important new drug for insomnia and will be a commercial success.… Cubist Makes Attractive Bid for AdolorInvestment View of the Proposed Acquisition Cubist announced today that it had signed a definitive agreement to acquire Adolor.
Adolor has been… Contrave Is Given New Life as FDA Reverses its Position on Design of Cardiovacular Outcomes Trial (OREX, $2.45)Investment Opinion Transcept to Resubmit Intermezzo NDA; Hopes for a Class I ReviewResubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA… FDA Cardiovascular and Renal Advisory Committee Goes Against FDA View and Recommends Approval of XareltoThe FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in… Hopes for Rivaroxaban Are Dashed (JNJ, $65.00) Dapagliflozin is Voted Down 6 to 9 by Advisory Committee: What's Next (BMY, $28.77)Overview of Advisory Committee Meeting Santarus 2009 Analyst Day Highlights (SNTS, $1.98)Management was quite optimistic about prospects for 2009 as both Zegerid and Glumetza are doing well. The company is looking… |
