Shares of US biotech firm MyoKardia (Nasdaq: MYOK) soared 83.38% to $31.45 by close of trading on Monday, after the company announced positive mid-stage results with its mavacamten, formerly known as MYK-461.
MyoKardia announced positive top-line data from the first patient cohort of its Phase II PIONEER-HCM study of mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) patients. This cohort met the primary endpoint of change in post-exercise peak left ventricular outflow tract (LVOT) gradient from baseline to week 12 as well as key secondary endpoints, including peak oxygen consumption (peak VO2).
Based on these results and subject to discussions in the coming months with the US Food and Drug Administration, MyoKardia is planning for its next study, EXPLORER-HCM, to be a pivotal study. EXPLORER-HCM is expected to initiate by the end of this year.
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