April 21 Quick Takes: LianBio’s mavacamten gets priority review in China
Plus: FDA extends PDUFA for Daiichi’s quizartinib, and updates from AbbVie, Apellis and more
LianBio (NASDAQ:LIAN) is nearing transition to a commercial-stage company after China’s NMPA accepted and granted priority review to an NDA for mavacamten to treat obstructive hypertrophic cardiomyopathy (oHCM). The filing is based on the global Phase III EXPLORER-HCM trial conducted by partner Myokardia, now a subsidiary of Bristol Myers Squibb Co. (NYSE:BMY), which led to the approval of mavacamten as Camzyos in the U.S. LianBio, which has rights to develop and commercialize the therapy in China and other Asian territories, is conducting the China-based Phase III EXPLORER-CN trial of mavacamten for oHCM, from which data are expected mid-year. LianBio gained $0.03 to $2.15 Friday.
Daiichi Sankyo Co. Ltd. (Tokyo:4568) will have to wait until the summer to receive a decision from FDA regarding first-line use of its acute myelogenous leukemia (AML) drug quizartinib after the U.S. agency said it needed an additional three months to review updates to the proposed REMS. The small molecule FLT3 inhibitor is under review in combination with standard consolidation chemotherapy for newly diagnosed, FLT3-ITD-positive AML patients. The new PDUFA date is July 24. Quizartinib is approved in Japan as Vanflyta to treat relapsed or refractory FLT3-ITD-positive AML...