Archive for March, 2018
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 the CAR-T products gain traction in the market. Novartis’ Kymriah and Gilead’s Yescarta are both in early stages of their launches- Kymriah for pediatric r/r ALL and Yescarta for r/r DLBCL. In its conference […]
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 Letter on Xyosted that was received in October 2017 just before its PDUFA date and necessitated a Type A meeting with the FDA to discuss the CRL. It says. ”Antares Pharma today announced that […]
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 date of May 4, 2018 even though the phase 3 trial that is the basis of the BLA leaves much to be desired. It is based on a single AndexXa arm which at this point […]
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 projected 4Q biopharma revenues (obviously the critical business segment) of $2.673 million and the Company reported $2.516 million. I guess you might call this a 157,000 shortfall (6% below projection), but well within the error […]
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 go over his key remarks in this report I have been frustrated by the CRL for Xyosted and delays in approval for AB rated versions of EpiPen and Byetta which have had a sharply […]
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 is an antidote for excessive bleeding that sometimes results from use of the Factor Xa anticoagulants Eliquis and Xarelto. Portola states that in the U.S. in 2017, there were approximately 150,000 hospital admissions that […]