Axsome fell after FDA refuses to review AXS-14 application

June 09, 2025 06:17 AM PDT | By EODHD

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Axsome fell after FDA refuses to review AXS-14 application — Image source: Kalkine Media

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[FDA - Food and Drug Administration text on document above brown envelope and stethoscope. Healthcare or medical concept] syahrir maulana/iStock via Getty Images Shares of Axsome Therapeutics (NASDAQ: NASDAQ:AXSM [https://seekingalpha.com/symbol/AXSM]) fell on Monday following the U.S. FDA's decision to not review the marketing application for esreboxetine or AXS-14, for the treatment of fibromyalgia. The FDA said that after an initial assessment, the New Drug Application submitted by the company, was not sufficiently complete for a thorough review. The agency specifically mentioned that the second of the two placebo-controlled trials presented in the application did not meet their standards for adequacy and control, as its primary endpoint was set at only 8 weeks and employed a flexible dosing strategy.

The FDA indicated that the first of the two placebo-controlled trials in the submission, which utilized a 12-week endpoint and a fixed-dose paradigm, is adequate and well-controlled. To address the agency’s feedback, Axsome will conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA. Axsome said that it anticipates [https://seekingalpha.com/pr/20129829-axsome-therapeutics-provides-update-on-the-new-drug-application-nda-for-axsminus-14-for-the]initiating this trial in the fourth quarter of 2025. The stock is down about 4% premarket. MORE ON AXSOME THERAPEUTICS * Axsome Therapeutics Q1: Marketing-Driven Growth Masks Profitability Concerns [https://seekingalpha.com/article/4782306-axsome-therapeutics-q1-marketing-driven-growth-masks-profitability-concerns] * Axsome Therapeutics, Inc.

(AXSM) Q1 2025 Earnings Call Transcript [https://seekingalpha.com/article/4781851-axsome-therapeutics-inc-axsm-q1-2025-earnings-call-transcript] * Axsome Therapeutics, Inc. 2025 Q1 - Results - Earnings Call Presentation [https://seekingalpha.com/article/4781809-axsome-therapeutics-inc-2025-q1-results-earnings-call-presentation] * Axsome initiated with Outperform at Oppenheimer on revenue boost [https://seekingalpha.com/news/4454986-axsome-initiated-with-an-outperform-at-oppenheimer-on-revenue-boost] * Axsome settles patent dispute with Hetero Labs over Sunosi generic [https://seekingalpha.com/news/4452485-axsome-settles-sunosi-patent-dispute-hetero]

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