The FDA Approves Bristol Myers Squibb's Supplemental New Drug Application To Add Data From The Phase 3 VALOR-HCM Study To The U.S. Prescribing Information For Camzyos (Mavacamten)
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The FDA has approved Bristol Myers Squibb's supplemental new drug application to add data from the Phase 3 VALOR-HCM study to the U.S. prescribing information for Camzyos (Mavacamten). This follows last year's FDA approval of Camzyos based on results from the Phase 3 EXPLORER-HCM trial.
June 16, 2023 | 8:41 am
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Bristol Myers Squibb's supplemental new drug application for Camzyos (Mavacamten) has been approved by the FDA, adding Phase 3 VALOR-HCM study data to the U.S. prescribing information.
The FDA approval of Bristol Myers Squibb's supplemental new drug application for Camzyos is a positive development for the company. This approval expands the data available for the drug, potentially increasing its usage and sales. As a result, this news is likely to have a positive short-term impact on BMY's stock price.
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