Tag archive for ‘AMAG Pharmaceuticals’
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I believe that there is a 95% probability that Makena will remain on the market and only a 5% chance that it could be withdrawn.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 […]
AMAG Pharmaceuticals: Strong Launch of Subcu Makena and Pending Sale of Cord Blood Registry is Encouraging (AMAG, $23.55, Buy)
Investment Thesis My April 13, 2018 report AMAG: Upgrading to Buy Based on an In-Depth Analysis of the Outlook for Makena Over the 2018 to 2020 Period (AMAG, Buy, $21.10) was based primarily on the belief that Makena sales could dramatically beat Wall Street analysts’ consensus expectations. Please refer to that report for my detailed […]
AMAG: It Is Early Days, but the Launch of the Subcutaneous Dosage Form of Makena Seems to be Going Very Well (AMAG, Buy, $21.17)
Investment Thesis The investment thesis for AMAG in 2018 and 2019is overwhelmingly dependent on how successful the Company will be in switching patients from the intra-muscular (IM) dosage of Makena to the new subcutaneous (subcu) formulation. The subcu was launched on March 26 and the first patient was injected on March 28. The subcu has […]
AMAG Pharmaceuticals: Initiation of Research on a Complex but Potentially Very Interesting Investment Situation (AMAG, Neutral, $24)
Organization of Report The first five pages of this report (section 1) provide a quick summary of my view of AMAG’s business outlook and how this leads to my investment thesis. It does not go into great depth as it is intended to give an impression so that you can decide whether you want to […]