Archive for October, 2019
AMAG Pharmaceuticals: AdCom Votes 9 to 7 to Remove Makena from the Market, but I Don’t Think It Will Happen: AMAG (AMAG, $9.80), Antares Pharma (ATRS, $3.40, Buy)
The FDA AdCom meeting voted 9 to 7 to withdraw Makena from the market. However, 6 of 7 practicing OB/GYNs on the panel voted to keep Makenna on the market and to do additional studies to properly define its role in the management of women with singleton pregnancies who previously have had a preterm birth. […]
AMAG Pharmaceuticals (AMAG, $12.20); Antares (ATRS, Buy, $3.59) What Will FDA AdCom Recommend on Makena in the Aftermath of Failed Prolong Trial?
Key Conclusions I believe that there is a 95% probability that Makena will remain on the market and only a 5% chance that it could be withdrawn. I think that results of PROLONG will be incorporated into the Makena label and the FDA may or may not ask for another trial. There is no approved […]
Cryoport: Stock Has Been Attacked by Short Sellers (CYRX, $14.57, Buy)
Opinion on Stock The recent sharp price decline has not been attributable to any change in perceived or actual fundamentals of Cryoport. (See the appendix of this report for a discussion on price behavior over the last month.) I have stated repeatedly that Cryoport has one of the best business models that I have seen […]
Aimmune Therapeutics: (AIMT, $23.63) Palforzia for Peanut Allergy Desensitization Has the Potential to Be a Blockbuster
Introduction Aimmune is the first company for some time on which I have picked up coverage. My screening criteria is not rigid, but I generally look for a company with a unique late stage product that has great commercial potential and has a solid financial (cash) position. Aimmune Therapeutics with Palforzia for desensitization of patients […]
Antares: Impressive Xyosted Prescription Trends Continue (ATRS, Buy, $3.30)
Key Points: Xyosted prescription trends remain impressive and based on audit data for the last 11 weeks, there has been an acceleration in the trend line. My model has slightly increased its 2019 sales estimate from $18.8 million as shown in my August 27 report to $19.4 million and for 2020 from $53.9 to $56.8 […]