Post archive for ‘Company Reports’
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 20 pages long. The catalyst for this report was the recent information on the still blinded phase 3 trial presented in June at ASCO. It will take dedicated investors a great deal of time […]
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. The failure was related to clogging of a cartridge used in the medical device used to deliver Aerosurf which affected some patients in the 50 minute dose cohort. In patients unaffected by this problem, results were positive and if they […]
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 jump in the stock price. The question I am asked is whether the stock will back off from current levels allowing investors to acquire the stock at a better price or even if existing […]
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 have recommended Repligen consistently since my initiation report of December 4, 2012 at a price of $6.13. My belief at the time and continues to be that this is one of the best healthcare […]
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 2018 in both the US and Europe. Betrixaban is an anticoagulant drug that is an oral factor Xa inhibitor. It has the same mechanism of action as two blockbuster drugs: Bristol-Myers Squibb/ Pfizer’s Eliquis ($3.3 […]
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 believes that these rates of growth could continue for the balance of 2017. Management also believes that it can reach breakeven or turn cash flow positive later in 2017. My model shows the Company achieving […]
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. In July, the critical results from the phase 2b trial of Aerosurf will be published. Before then in June, results from the phase 2a trial in babies of the 26 to 28 weeks will […]
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 2b proof of concept trial of Aerosurf in premature babies with RDS syndrome. It is on track to run out of cash in July if it does not receive some type of cash infusion. […]
Cryoport: Observations on 1Q, 2017 Results (CYRX, Buy, $3.05)
Investment Section Overview This report is a follow-up to my April 12, 2017 report “Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)”. If you are unfamiliar with or need a refresher on Cryoport’s business, I would suggest that you read that report before continuing. By every measure […]
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 of drugs for ALS; this was the first such approval in 20 years. This urgency should extend to getting tirasemtiv on the market if results are generally positive; topline results from the phase 3 VITALITY-ALS […]