Post archive for ‘Company Reports’
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 time frame. Subsequently, the Company alerted investors to a manufacturing issue that could delay the launch. During yesterday’s conference call, the Company said that it hopes to be able to launch in November, but […]
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 an author who uses the pseudonym Bohsie. He looks at the unblinded data from the phase 3 trial of DCVax-L and hypothesizes that the data seems highly supportive of the hope that the phase […]
Antares Pharma: This Small, Emerging Biotechnology Company Is Poised for Explosive Growth Based on Five Major New Product Introductions by 2020 (ATRS, Buy, $3.02
Investment Thesis Antares is one of my top recommendations based on its extremely impressive pipeline prospects. In a March 23, 2017 report Antares: Pipeline is Bursting with Late Stage Products (ATRS, $2.77, Buy) I did an in-depth analysis that goes over my assumptions and resultant projections in great detail for the five partnered products and two […]
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 but never recommended purchase, until I upgraded my opinion to a Buy on June 21, 2017. See Alimera Sciences: Iluvien Sales Seem to Have Caught Traction; It Is Time to Buy! (ALIM, Buy, $1.35) […]
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 trailing twelve months basis). It is still too small to catch the eyes of large investors. Also, it is not well understood as it has a very unique business model that requires both 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, 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 […]