Axsome Therapeut Stock Price, News & Analysis

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) disorders, has announced it will release its third quarter 2024 financial results on Tuesday, November 12, 2024, before the U.S. financial markets open. The company's management will host a conference call at 8:00 a.m. Eastern Time on the same day to discuss the results and provide a business update.

Interested parties can participate in the live conference call by dialing (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the call will be available on the company's website under the "Webcasts & Presentations" page in the "Investors" section. A replay of the conference call will be accessible on Axsome's website for approximately 30 days following the event.

Axsome Therapeutics (NASDAQ: AXSM) announced seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society. The presentations include data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey on unmet needs in type 1 narcolepsy, and previously reported data on solriamfetol showing improvement in cognitive function in patients with excessive daytime sleepiness associated with OSA and narcolepsy.

The presentations cover various aspects of sleep disorders, including treatment outcomes, symptom burden, quality of life, and cognitive effects. Notable presentations include topline results from the SYMPHONY trial, real-world use of solriamfetol in patients with anxiety or depression, and effects of solriamfetol on cognition in obstructive sleep apnea patients with excessive daytime sleepiness.

Axsome Therapeutics (NASDAQ: AXSM) announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for AXS-07, a treatment for acute migraine. The FDA has classified it as a Class 2 resubmission and set a PDUFA action goal date of January 31, 2025. This development marks a significant milestone in Axsome's efforts to bring a new migraine treatment to market. The acceptance of the NDA resubmission indicates progress in addressing previous FDA concerns and moves AXS-07 closer to potential approval. Investors and patients alike will be closely watching the outcome, as a successful approval could impact both Axsome's market position and migraine treatment options.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, has announced its participation in four major investor conferences in September 2024:

1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York (presentation at 4:50 p.m. ET)
2. Wells Fargo Healthcare Conference on September 5 in Boston (investor meetings)
3. Baird 2024 Global Healthcare Conference on September 11 in New York (presentation at 8:30 a.m. ET)
4. Cantor Global Healthcare Conference on September 18 in New York (presentation at 9:45 a.m. ET)

Live webcasts of the presentations at the Morgan Stanley and Cantor conferences will be available on Axsome's website, with replays accessible for approximately 30 days after each event.

Axsome Therapeutics (NASDAQ: AXSM) has announced an agreement with Sandoz Inc. to dismiss the patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation was pending in the U.S. District Court for the District of New Jersey and stemmed from Sandoz's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic equivalent of Sunosi in the United States. As part of the agreement, Sandoz has withdrawn its ANDA for a generic equivalent of Sunosi, resulting in the dismissal of the litigation without prejudice.

Axsome Therapeutics (NASDAQ: AXSM) reported strong Q2 2024 financial results, with total net product revenue of $87.2 million, up 87% year-over-year. Auvelity sales grew 135% to $65.0 million, while Sunosi revenue increased 16% to $22.1 million. The company resubmitted its NDA for AXS-07 in migraine and expects to submit an NDA for AXS-14 in fibromyalgia in Q3 2024. Axsome anticipates topline results from multiple Phase 3 trials in H2 2024, including studies of AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD. Despite strong revenue growth, the company reported a net loss of $79.3 million for Q2 2024, compared to $67.2 million in Q2 2023, primarily due to increased R&D and SG&A expenses.

Axsome Therapeutics (NASDAQ: AXSM), a leading biopharmaceutical company specializing in CNS disorder treatments, announced it will report its Q2 2024 financial results on August 5, 2024, before U.S. markets open. The management will host a conference call at 8:00 a.m. ET to discuss the results and provide a business update. Investors can join the call via a toll-free number or access a live webcast through the company's website. A recording will be available for 30 days post-event.

Axsome Therapeutics (NASDAQ: AXSM) announced a settlement with Unichem Laboratories regarding patent litigation for Sunosi® (solriamfetol). The litigation arose after Unichem filed for FDA approval to market a generic version of Sunosi in the U.S. per an Abbreviated New Drug Application. The settlement allows Unichem to sell its generic version starting June 30, 2042, with possible earlier entry under specific conditions. Additionally, the date could be extended for pediatric exclusivity. The agreement will be reviewed by the U.S. Federal Trade Commission and the Department of Justice. Similar litigation with other parties continues in the District of New Jersey.

Axsome Therapeutics (NASDAQ: AXSM) announced its participation in the American Migraine Foundation's efforts for Migraine & Headache Awareness Month in June 2024. This initiative aims to raise awareness about unmet treatment needs for the 37 million Americans suffering from migraines, which cause significant physical, emotional, and economic impacts. The American Migraine Foundation emphasizes the importance of education, support, community, and research to improve patient outcomes and societal attitudes toward migraines. Notably, 70% of migraine sufferers are dissatisfied with current treatments, and nearly 80% are open to trying new therapies.