Axsome Therapeutics, Inc. (AXSM) has received a significant boost for its migraine treatment, AXS-07, with the FDA accepting its resubmitted New Drug Application (NDA). The FDA has classified this resubmission as a Class 2, indicating a standard review process. This positive development brings Axsome closer to expanding its treatment options and potentially generating significant revenue. The FDA is expected to make a final decision on the approval by January 31, 2025. Following the announcement, AXSM shares experienced a surge of 6.6% on September 4th, reflecting investor optimism.
This positive news marks a milestone for Axsome, as the FDA had previously issued a complete response letter in April 2022 for the initial NDA. This initial rejection was attributed to concerns regarding the chemistry, manufacturing, and controls of the drug. Axsome diligently addressed these concerns and completed the resubmission during the second quarter of 2024. Importantly, the FDA did not request any further safety or efficacy data for the resubmission, indicating a positive assessment of the drug’s potential.
The FDA’s acceptance of the NDA resubmission has the potential to significantly diversify Axsome’s product portfolio. The company currently holds two marketed products: Auvelity (AXS-05) for major depressive disorder and Sunosi (solriamfetol) for narcolepsy. Auvelity, launched in 2022, has shown strong performance, generating sales of $118.4 million in the first half of 2024, a 172.8% year-over-year increase. Sunosi, acquired from Jazz Pharmaceuticals in 2022, also exhibited solid growth, with net product sales reaching $42.2 million in the first half of 2024, representing a 35.2% increase year-over-year. The addition of AXS-07, if approved, will further bolster Axsome’s revenue streams and solidify its position as a leading player in the pharmaceutical industry.
Axsome’s journey to secure approval for AXS-07 is a testament to its commitment to developing innovative treatments for challenging medical conditions. The FDA’s acceptance of the NDA resubmission is a strong indicator that AXS-07 holds significant promise as a treatment for migraine. Investors will be closely watching for the FDA’s final decision in January 2025, as it could potentially reshape Axsome’s future and offer a new hope for millions of migraine sufferers.
