Axsome Therapeutics, Inc - AXSM STOCK NEWS

Axsome Therapeutics (NASDAQ: AXSM) has announced preliminary net product revenue for Q4 and full year 2024. The company reported strong revenue growth with total product revenue expected at $118.3 million for Q4 and $385.2 million for full year 2024.

Breaking down the revenue: Auvelity net product sales reached approximately $92.6 million in Q4 and $291.4 million for the full year, while Sunosi contributed approximately $25.7 million in Q4 and $93.8 million for the full year.

The company achieved positive Phase 3 results for AXS-05 in Alzheimer's disease agitation and AXS-12 in narcolepsy, with regulatory filings planned for 2025. Axsome is also preparing for the potential launch of AXS-07 for acute migraine treatment, pending approval.

Axsome Therapeutics (NASDAQ: AXSM) announced successful completion of Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation. The ACCORD-2 Phase 3 trial achieved its primary endpoint, showing AXS-05 significantly delayed time to relapse compared to placebo (p=0.001) with a 3.6-fold lower risk of relapse. The drug also met key secondary endpoints and reduced overall Alzheimer's disease severity.

While the ADVANCE-2 trial did not reach statistical significance, it showed numerical improvements over placebo. The drug demonstrated positive safety profiles in both controlled and long-term trials, with no association to increased falls, cognitive decline, or sedation. Based on four completed pivotal Phase 3 trials, Axsome plans to submit a New Drug Application (NDA) to the FDA in second half of 2025.

Axsome Therapeutics (NASDAQ: AXSM) announced positive results from the ENCORE Phase 3 trial of AXS-12 in narcolepsy with cataplexy. The drug achieved its primary endpoint, showing a statistically significant reduction in cataplexy attacks compared to placebo (p=0.017). During the 6-month open-label period, patients experienced a 71% reduction in cataplexy attacks at 1 month and 77% reduction at 6 months. The trial demonstrated significant improvements in excessive daytime sleepiness, cognition, and overall narcolepsy symptoms. AXS-12 was well-tolerated with no new safety concerns, showing consistent results with previous trials.

Axsome Therapeutics (AXSM) reported strong Q3 2024 financial results with total net product revenue of $104.8 million, up 81% year-over-year. Auvelity sales reached $80.4 million (+113% YoY) while Sunosi revenue was $24.4 million (+21% YoY). The company reported a net loss of $64.6 million. Key upcoming milestones include FDA PDUFA date for AXS-07 migraine treatment (January 31, 2025), planned sales force expansion, and multiple Phase 3 trial results expected in Q4 2024 and Q1 2025. Cash position stands at $327.3 million, which management believes is sufficient to fund operations until cash flow positivity.

Axsome Therapeutics (NASDAQ: AXSM) announced eight presentations at NEI Congress 2024, showcasing data from its late-stage CNS portfolio. The presentations cover multiple therapeutic areas including Major Depressive Disorder (featuring AXS-05/Auvelity® data from clinical trials and real-world studies), Alzheimer's Disease Agitation (Phase 2/3 development program results), and OSA and Narcolepsy (focusing on Solriamfetol's effects on excessive daytime sleepiness and cognition). The presentations include pooled data from controlled trials and real-world studies, examining treatment outcomes, patient characteristics, and cognitive effects.

Axsome Therapeutics (NASDAQ: AXSM) announced seven presentations at Psych Congress 2024 showcasing data from its neuroscience portfolio. The presentations cover multiple therapeutic areas including Major Depressive Disorder, featuring studies on AXS-05 (Auvelity®), Alzheimer's Disease Agitation with Phase 2/3 development program results, and research on Solriamfetol for excessive daytime sleepiness in patients with narcolepsy and OSA. The presentations include data on improving anhedonia, interest-activity symptoms, and cognitive effects in various patient populations.

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.