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Wednesday, July 14, 2021

FDA rescinds breakthrough tag for Axsome narcolepsy med

 Axsome Therapeutics - Notified by U.S. FDA That It is Rescinding Co’s Breakthrough Therapy Designation for Its Axs-12 Product Candidate.

Axsome - FDA Btd Rescindment Due to It Approving Additional Drug Product for Treatment of Cataplexy in Narcolepsy Subsequent to Granting Axs-12 Btd.
Axsome - Does Not Currently Anticipate Any Changes to Development Plans Or Associated Timelines for Axs-12 As a Result of FDA Btd Rescindment.

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