Axsome Therapeutics, Inc 8-K, filed Jul 13, 2021
Axsome Therapeutics, Inc. (AXSM)
About this 8-K
Axsome Therapeutics, Inc filed this 8-K on July 13, 2021.
Items reported
- Item 8.01: Other events
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Item 8.01 Other Events.
Axsome Therapeutics, Inc. (the “Company”) today announced that it has been notified by the U.S. Food and Drug Adminstration (the “FDA”) that the FDA is rescinding the Company’s Breakthrough Therapy Designation for its AXS-12 product candidate for the treatment of cataplexy in narcolepsy, due to the FDA approving an additional drug product for the treatment of cataplexy in narcolepsy subsequent to granting AXS-12 Breakthrough Therapy Designation.
The Company does not currently anticipate any changes to the development plans or associated timelines for AXS-12 as a result of this change.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Axsome Therapeutics, Inc. |
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Dated: July 13, 2021 |
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By: |
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/s/ Herriot Tabuteau, M.D. |
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Name: |
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Herriot Tabuteau, M.D. |
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Title: |
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President and Chief Executive Officer |
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