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Expert Financial Analysis and Reporting

Post archive for ‘Company Reports’

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, which is in line with prior management guidance. I anticipate a six month review and US approval in 1Q, 2018. If so, it will represent the second approval of a potential blockbuster for Portola […]

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 unimportant. The stock price is driven by investors’ assessments on clinical progress of three late stage pipeline products: omecamtiv mecarbil (for congestive heart failure) and tirasemtiv (for amyotrophic lateral sclerosis or ALS) are […]

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 report of July 19, 2017. Without information contained in these reports, it might be difficult to put my comments in this note in perspective. Based on new guidance from CEO Jerry Shelton, it appears that […]

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 on manipulation of genes, most commonly referred to as gene therapy. This promises to be a new dynamic to biopharma drug development that will be a strong (the major?) driver of industry revenues for the […]

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 relapsed/ refractory acute lymphocytic leukemia. This will be the first FDA review of the new CAR-T products. I have spent some of today reading the FDA briefing documents for the members of the committee. There […]

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 […]