Bristol Myers' Mavacamten Added Via $13B Myokardia Buyout, Hit By FDA Delay

  • Bristol Myers Squibb & Co BMY has announced that the FDA has extended the decision date for mavacamten.
  • Bristol Myers announced that the date has slid from January 28, 2022, to April 28, 2022. 
  • The details were slim, but the Company said the FDA notified them Thursday that they needed more time to consider an update to the Risk Evaluation Mitigation (REMS) program.
  • The FDA accepted mavacamten in March this year, meaning should it take until late April to make a decision, it would have taken more than a year.
  • The Company is seeking approval for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy, an inherited disorder that causes the muscle walls of the heart to thicken, sometimes to the point at which they can obstruct blood flow.
  • Neither new studies nor new data have been requested by the FDA, according to BMS.
  • Related Link: Bristol Myers Rolls Out Long-Term Data For Mavacamten In Heart Disease.
  • Price Action: BMY shares are down 1.46% at $58.18 during the market session on the last check Friday.
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