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Monday, August 9, 2021

Axsome Therapeutics (AXSM) : disappointing regulatory update for AXS-05

 Disappointing regulatory update for AXS-05 as a potential treatment for major depressive disorder (MDD).  
  • Specifically, Axsome revealed during its 2021 second-quarter earnings release this morning that the U.S. Food and Drug Administration (FDA) had notified the company on July 30, 2021 that it has identified deficiencies within the drug's regulatory application that preclude discussion of labeling and post-marketing requirements at this time. A final decision on AXS-05's regulatory review for MDD is currently slated for Aug. 22, 2021.


The company announced that AXS-05 met the primary and key secondary endpoints in the Phase 2 MERIT trial and "substantially and statistically significantly prevented relapse of depressive symptoms compared to placebo in patients with treatment resistant depression." Co further stated, among various business updates, that as part of the ongoing review of its NDA for AXS-05, the FDA recently notified co that it has identified deficiencies that preclude labeling discussions at this time; the development may lead to a delay in the potential approval of AXS-05. Co also reported Q2 results. At 52-week lows.


New York, NY-based Axsome Therapeutics (NASDAQ:AXSM) had its IPO on Nov 20, 2015 IPO. The stock opened at $9.00 on its first day of trading.

The clinical stage biopharmaceutical firm develops therapies for the management of pain and disorders of the central nervous system (CNS). Its lead product candidate is Phase 3-stage AXS-02 (disodium zoledronate tetrahydrate), a non-opioid therapeutic for chronic pain. The company is targeting three specific areas for development: complex regional pain syndrome, osteoarthritis of the knee associated with bone marrow lesions and chronic low back pain associated with Modic changes (changes in bones of the spine). Its second candidate is Phase 3-stage AXS-05, a fixed dose of combination of dextromethorphan and bupropion, for treatment-resistant depression and Alzheimer's disease-associated agitation.

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