China NMPA accepts with priority review LianBio's NDA for mavacamten in oHCM

LianBio

NMPA accepted NDA for mavacamten for symptomatic obstructive HCM in adults; priority review granted.
NDA based on global Phase 3 EXPLORER-HCM trial and LianBio's Phase 1 PK study in Chinese volunteers.
Blinded preliminary safety data from ongoing Phase 3 EXPLORER-CN trial supported early filing; topline results expected mid-2023.
CEO states this is a pivotal moment as LianBio prepares to become a commercial-stage company.

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