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

To view the source of this information click here

To contact the reporter on this story:
Sonali Pathirana in New York at spathirana@bloomberg.net

To contact the editor responsible for this story:
Stephen Foxwell at sfoxwell@bloomberg.net

© 2020 Bloomberg L.P. All rights reserved. Used with permission. ...

To read the full article log in.

Learn more about a Bloomberg Law subscription.