Archive for April, 2017
Thoughts on the Probable Launches of the First CAR-T Drugs; Cryoport is a Novel Way to Invest In This: Cryoport (CYRX, Buy, $2.36) and Kite (KITE, Neutral, $83.37)
Key Points: I continue to think that first ever CAR-T drug approval will be for Novartis’ CTL-019 in r/r pediatric ALL in September or October of 2017. Not long afterwards (weeks or a month or two), my best judgment is that CTL-019 and Kite’s Axi-Cel will be approved at the same time for the second […]
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 will be added to the S&P 600 small cap index. There is no fundamental news. I have seen before that when a stock is added to an index that the price jumps up meaningfully as […]
Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)
AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with guidance. AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector using an auto-injector developed by Antares. AMAG revealed that it will […]
Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)
Introduction I am recommending purchase of Cryoport, which has developed a first mover, business model for providing cold chain logistics for high value life science products requiring cryogenic temperatures during shipment. This is report is divided into four sections: Investment Thesis: The first 11 pages of this report summarize the reasons why I am recommending […]
Repligen: A Business Update and Reiteration of Buy (RGEN, Buy, $34.11)
Investment Overview and Thesis A Long Buy Recommendation of Mine I first recommended Repligen in an initiation report in December 2012. At the time and on many occasions since, I have described its business model as being one of the very best I have seen. On a macro-basis its business sail is driven by the […]
Cytokinetics: Insights into Corporate Collaborations, Tirasemtiv, CK-107 and Hospitalization Caused by Heart Failure (CYTK, Buy, $11.25)
Introduction I was just going though the most recently published slide deck of Cytokinetics and found some slides that I thought were an interesting way of conveying information on corporate collaborations, the clinical status of CK-107, tirasemtiv and the serious unmet medical need for treatment of patients hospitalized with heart failure. None of these are […]
Kite Pharma: Novartis and Kite File for Regulatory Approval of Their CAR-T Products; I Do Not Believe That KITE Has a Meaningful First Mover Advantage (KITE, Neutral, $82.19)
Key Points: Novartis will almost certainly gain approval for CTL-019 in r/r pediatric ALL early in 4Q, 2017. This would represent the first ever approval for a CAR-T product. Kite says that it will receive approval for Axi-Cel ((axicabtagene ciloleucel)) in r/r DLBCL and launch in the US in 2017 and will have first mover […]