Axsome Shares Jump 19% After FDA Acceptance Of AX-S12 Priority Review And Positive Pre-NDA Feedback

(RTTNews) - Axsome Therapeutics, Inc. (AXSM) shares rose 19.37%, trading at $177.62, up $28.83, after the company announced that the FDA accepted its New Drug Application (NDA) for AX-S12 with Priority Review and shared positive insights from a recent FDA pre-NDA meeting regarding the program.

The rally follows the FDA's formal acceptance of Axsome's NDA for AX-S12, advancing a potential new treatment for stress urinary incontinence with a priority review designation, which could accelerate the regulatory timeline. In addition, feedback from the FDA's pre-NDA meeting minutes indicated constructive engagement on clinical and regulatory considerations for AX-S12's development path.

On the announcement day, AXSM opened near $150.00, climbed to an intraday high above $180.00, and touched a low near $148.50, compared with a previous close of $148.79. The stock trades on the Nasdaq.

Trading volume was unusually heavy, well above the stock's average daily volume, reflecting strong investor response to the regulatory progress and evolving prospects for AX-S12.

Axsome's 52-week range is approximately $95.00 - $181.25, reflecting heightened volatility tied to clinical and regulatory newsflow.