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Myokardia Gets FDA Breakthrough Designation For Mavacamten

July 23, 2020, 8:17 PM

MyoKardia, Inc. said that the FDA has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM).

  • company is currently preparing an NDA for mavacamten, with plans to submit to the FDA in the 1Q 2021
  • Shares rose 1.8% in post-market trading

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