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Letter from FDA outlining deficiencies for lead drug causes Axsome stock to crater. Is a CRL on the way?

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The FDA has concerns with Axsome’s lead and potential blockbuster drug to treat major depressive disorder, which sent the company’s stock price down by more than 40% early Monday.

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Endpoints

Axsome celebrates migraine PhIII win, shifting eyes toward a pair of Q4 submissions

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One week after reporting a late-stage failure for its lead drug, Axsome is back with positive news: In the 302-person Phase III INTERCEPT trial, its experimental migraine drug hit both primary endpoints: Stopping migraine pain entirely and preventing pain from progressing beyond ”mild intensity.”

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Endpoints