Axsome Therapeutics' AXS-07 for Migraine Gets FDA Nod
The U.S. Food and Drug Administration (FDA) has accepted Axsome Therapeutics' resubmitted new drug application (NDA) for AXS-07, a treatment for acute migraine. The agency is expected to make a final decision on January 31, 2025.
This news sent Axsome's shares soaring 6.6% on September 4, 2024. The company's stock has rallied 20.1% year-to-date, outperforming the industry's decline of 0.9%.
The FDA had previously issued a complete response letter to the first NDA for AXS-07 in April 2022 due to concerns related to chemistry, manufacturing, and controls. Axsome addressed these issues and resubmitted the NDA in the second quarter of 2024. The FDA has not requested any additional safety or efficacy data for the resubmission.
Axsome's Growing Portfolio
Auvelity for major depressive disorder and Sunosi for narcolepsy. Auvelity, launched in 2022, generated sales of $118.4 million in the first half of 2024, a 172.8% year-over-year increase. Sunosi, acquired from Jazz Pharmaceuticals in May 2022, generated net product sales of $42.2 million in the first half of 2024, a 35.2% year-over-year increase.
An FDA approval for AXS-07 would further diversify Axsome's commercial portfolio and provide a potential new revenue stream.
Other Biotech Stocks to Watch
Krystal Biotech (KRYS) and Fulcrum Therapeutics (FULC) are two other biotech stocks with strong growth potential. Both companies have a Zacks Rank #1 (Strong Buy) and have seen significant increases in their share prices year-to-date.
KRYS' earnings beat estimates in three of the past four quarters and its 2024 and 2025 earnings per share estimates have been revised upwards. FULC's earnings have also consistently beat estimates, and its 2024 and 2025 loss per share estimates have been revised downwards.