Bristol-Myers Squibb Company (NYSE: BMY) disclosed Friday that FDA has acknowledged the New Drug Application (NDA) of Mavacamten. FDA has decided to review the NDA of Mavacamten which is an investigational drug for the cure of the cardiac condition. The FDA has also provided the PDUFA goal date of January 28, 2022.
The firm has submitted the NDA based on outcomes of the crucial Phase 3 EXPLORER-HCM trial, which assessed Mavacamten in sufferers with indicative oHCM versus placebo. Outcomes of the study disclosed that Mavacamten has shown a strong treatment result.
Mavacamten has not received authorization in any country until now. Mavacamten is considered to work by decreasing cardiac muscle contractility by preventing unnecessary myosin-actin cross-bridge creation that causes hypercontractility, left ventricular hypertrophy, and decreased compliance.
Shares of Bristol Myers went up 0.55% at $62.67 during the pre-market trading session of Friday. In the past 52-weeks of the trading session, the share of the firm went up to $45.76 from its 52-week of low range and plunged $67.16 from its 52-week of high range. Looking at its profitability, it has ROA of -7.20, ROE -19.30%, and ROI of -12.10%. Bristol Myers market capitalization has reached $138.98 billion at the time of writing.