Axsome’s Wait Pays Off With Broad Auvelity Label For Major Depression
After a year-long delay, Axsome gets US FDA approval of bupropion/dextromethorphan combo with broad label for major depression. Firm expects to launch in Q4 with pricing intended for broad patient access.
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Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.
In this week's podcast edition of Five Must-Know Things: Axsome gets broad label for new depression drug; Argenx CEO on Vyvgart’s success; Chinese firms delist from US; solid results for Novo Nordisk’s new diabetes combo; and women leaders herald change at foreign firms in India.
Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker