Replies to post #240400 on Biotech Values

[puravida]

come on Caforio. call Greenleaf. close the deal already and give your stakeholders a new and FDA approved asset in the portfolio. :)

[DewDiligence]

BMY’s reports detailed Mavacamten data from phase-3 VALOR trial:

https://www.businesswire.com/news/home/20220401005495/en

Bristol Myers Squibb today announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines at baseline. Study participants were on maximally tolerated background regimens when they entered the trial and remained on them through the duration of the study. These data were presented today as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session.

At 16 weeks the primary and all secondary endpoints were met. Of patients treated with mavacamten, 82% had not proceeded with SRT and no longer met the criteria for SRT according to the 2011 ACC/AHA Guidelines compared to 23% of patients receiving placebo.

BMY announced in Feb 2022 that this trial net its primary/secondary endpoints (https://www.businesswire.com/news/home/20220215005925/en ), but the details hadn’t been disclosed until today’s ACC meeting.

Mavacamten is under FDA review for a less-sick population with obstructive HCM; the PDUFA date for that indication is 4/28/22.

BMY acquired Mavacamten in the 2020 buyout of MYOK for $13.1B (#msg-158698900). BMY thinks Mavacamten will become a $4B/year drug in due course.

[DewDiligence]

FDA approves BMY’s Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy:

https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-Camzyos-mavacamten-for-the-Treatment-of-Adults-With-Symptomatic-New-York-Heart-Association-Class-II-III-ObstructiveHypertrophic-Cardiomyopathy-HCM-to-Improve-Functional-Capacity-and-Symptoms/default.aspx

BMY thinks Camzyos will have peak annual sales of at least $4B. This is the drug BMY got in the $13.1B acquisition of MYOK in Oct 2020 (#msg-158698900). Please see #msg-168424267 for the most recent dataset.