Shots:

• The NDA submission is based on results from the P-III EXPLORER-HCM trial involves assessing Mavacamten vs PBO in 251 patients with symptomatic oHCM. The FDA has anticipated a PDUFA date of January 28- 2022
• The P-III EXPLORER-HCM trial results demonstrated the robust treatment effect- with patient responses to treatment- including reductions in symptoms- functional status- QoL and reduction or elimination of the obstruction of the left ventricle. The study met 1EPs and 2EPs with statistical significance
• Mavacamten is an oral- allosteric modulator of cardiac myosin for patients with symptomatic oHCM and is currently not approved for use in any country

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