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Tuesday, June 15, 2021

Axsome to Seek FDA OK of AXS-14 for Fibromyalgia by End 2022

 Axsome Therapeutics Inc. on Tuesday said it plans to file for U.S. Food and Drug Administration approval of AXS-14 for the management of fibromyalgia by the end of next year.

The New York biopharmaceutical company said a pair of placebo-controlled trials have shown the potential for AXS-14 to improve the symptoms of the debilitating central-nervous-system condition, which currently has limited treatment options.

Axsome said it plans to submit a new drug application for AXS-14 in the fourth quarter of 2022, pending successful completion of manufacturing and other activities related to the product candidate.

https://www.marketscreener.com/quote/stock/AXSOME-THERAPEUTICS-INC-24949017/news/Axsome-Therapeutics-to-Seek-FDA-OK-of-AXS-14-for-Fibromyalgia-by-End-2022-35610568/

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