Axsome Therapeut Stock Price, News & Analysis

Axsome Therapeutics (NASDAQ: AXSM) is presenting data from three neuroscience programs at the ASCP 2025 Annual Meeting in Scottsdale, Arizona. The presentations include: 1. AUVELITY®: Expert panel recommendations for initiating treatment in Major Depressive Disorder (MDD) patients, presented by Dr. Anita Clayton from the University of Virginia. 2. AXS-05: Results from a Phase 3 randomized-withdrawal study on efficacy and safety in Alzheimer's Disease Agitation, presented by Dr. Jeffrey Cummings from UNLV. 3. Solriamfetol: Real-world SURWEY study data on treating excessive daytime sleepiness in narcolepsy and OSA patients with anxiety and depression, presented by Dr. Ulf Kallweit from Witten/Herdecke University.

Axsome Therapeutics (NASDAQ: AXSM) has reached a settlement agreement with Hetero Labs Ltd. regarding patent litigation for its drug SUNOSI® (solriamfetol). The litigation arose from Hetero's submission of an Abbreviated New Drug Application seeking approval for a generic version of SUNOSI. Under the settlement terms, Axsome will grant Hetero a license to sell its generic version starting either September 1, 2040 (if pediatric exclusivity is granted) or March 1, 2040 (without pediatric exclusivity), subject to FDA approval. The agreement will be reviewed by the U.S. Federal Trade Commission and Department of Justice. Similar patent litigation with other parties remains pending.

Axsome Therapeutics (NASDAQ: AXSM) has secured a $570 million term loan and revolving credit facility with Blackstone, replacing its previous Hercules Capital term loan. The facility consists of a $500 million term loan and a $70 million revolving credit facility. The company initially drew $120 million to retire its previous loan.

The new facility offers improved terms, including interest rates of SOFR plus 4.75% for the term loan and SOFR plus 4.0% for the revolving credit facility, with a 60-month interest-only period and maturity in May 2030. Additionally, Blackstone purchased $15 million of Axsome common stock at $107.14 per share. The company can access an additional $250 million at its option, with another $200 million available subject to Blackstone's approval.

Axsome Therapeutics (AXSM) reported strong Q1 2025 financial results with total net product revenue of $121.5M, up 62% year-over-year. Key highlights include AUVELITY sales of $96.2M (+80% YoY) and SUNOSI revenue of $25.2M (+17% YoY). The company received FDA approval for SYMBRAVO for acute migraine treatment, with launch planned for June 2025. Axsome submitted an NDA for AXS-14 (fibromyalgia) and plans submissions for AXS-05 (Alzheimer's agitation) and AXS-12 (narcolepsy) later in 2025. The company reported a net loss of $59.4M ($1.22/share) and maintains $300.9M cash position, sufficient to fund operations until cash flow positivity. Pipeline progress includes positive Phase 3 results for solriamfetol in ADHD and planned trials in multiple indications.

Axsome Therapeutics (NASDAQ: AXSM) is partnering with Mental Health America (MHA) to promote Mental Health Month in May 2025. As part of MHA's "Light Up Green" initiative, Axsome's NYC headquarters at One World Trade Center will be illuminated in green to raise mental health awareness.

The collaboration highlights concerning mental health statistics in the US: nearly 1 in 4 adults live with mental illness, and more than 1 in 8 people aged 12 or older reported feeling depressed in the past two weeks. Almost 90% of people with depression experience difficulties with work, home, or social activities.

The initiative provides various resources including MHA's Mental Health Month Action Guide, ADAA's Mental Health Webinars, and NAMI's awareness campaign. The 988 Suicide & Crisis Lifeline is available 24/7 for those in crisis.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on CNS disorders, has announced its participation in four major investor conferences in May 2025:

• Citizens Life Sciences Conference - May 7, 1:30 PM ET in New York
• BofA Securities Health Care Conference - May 13, 3:00 PM PT in Las Vegas
• RBC Capital Markets Global Healthcare Conference - May 20, 3:05 PM ET in New York
• Mizuho Neuro & Ophthalmology Summit - May 21 in New York

Live webcasts will be available for the Citizens, BofA, and RBC conferences through the company's website at axsome.com, with replays accessible for approximately 30 days after each event.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, has scheduled its first quarter 2025 financial results announcement for Monday, May 5, 2025, before U.S. markets open.

The company will host a conference call at 8:00 a.m. Eastern Time on the same day, featuring management discussion of results and business updates. Investors can join via phone at (877) 405-1239 (domestic) or +1 (201) 389-0851 (international), or watch the webcast through Axsome's website. A replay will be available online for approximately 30 days after the event.

Axsome Therapeutics (NASDAQ: AXSM) announced multiple presentations at the 2025 American Academy of Neurology Annual Meeting in San Diego. The presentations showcase results from two pivotal Phase 3 trials: the ACCORD-2 trial of AXS-05 for Alzheimer's disease agitation and the SYMPHONY trial of AXS-12 for narcolepsy.

The ACCORD-2 results were accepted as a late-breaking abstract, highlighting the efficacy and safety of AXS-05 in a randomized withdrawal double-blind placebo-controlled study. Additionally, the company will present data from a network meta-analysis comparing SYMBRAVO® (AXS-07) to oral CGRPs for acute migraine treatment.

Key presentations include Dr. Michael J. Thorpy's discussion of the SYMPHONY trial results and the CRESCENDO survey findings on narcolepsy Type 1 patients' symptom burden and quality of life. Dr. Stephanie Nahas will present the comparative efficacy analysis of AXS-07 versus gepants for migraine treatment.

Axsome Therapeutics (NASDAQ: AXSM) announced topline results from the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD). While the study did not meet its primary endpoint of statistically significant change in MADRS total score in the overall population, promising results were observed in a prespecified subgroup.

The 6-week trial included patients with severe excessive daytime sleepiness (EDS) (n=51) and without severe EDS (n=295). In the EDS subgroup, solriamfetol 300 mg showed clinically meaningful improvements compared to placebo across multiple efficacy measures, including MADRS total score, anhedonia subscale, and remission rates.

Based on these results, Axsome plans to initiate a new Phase 3 trial specifically targeting MDD patients with EDS in 2025. The condition affects approximately 50% of MDD patients, representing a significant unmet medical need with no currently approved therapies. The drug demonstrated a safety profile consistent with previous findings.