Axsome Therapeut Stock Price, News & Analysis

Axsome Therapeutics (NASDAQ: AXSM) has launched SYMBRAVO (meloxicam and rizatriptan), a novel prescription medication for acute migraine treatment in adults, now available in the United States. SYMBRAVO utilizes a multi-mechanistic approach targeting multiple brain pathways involved in migraine attacks, providing rapid pain relief within 2 hours and lasting up to 24 hours in some patients after a single dose. The launch addresses a significant unmet need, as migraine affects approximately 40 million Americans, with 63% of patients reporting dissatisfaction with current treatments. To support patient access, Axsome has introduced the SYMBRAVO On My Side program, offering savings for eligible commercially insured patients and comprehensive educational resources. The medication, powered by Axsome's patented MoSEIC technology, represents a new treatment option for the second leading cause of disability worldwide.

Axsome Therapeutics (NASDAQ: AXSM) received a Refusal to File (RTF) letter from the FDA regarding their New Drug Application for AXS-14 (esreboxetine) for fibromyalgia management. The FDA found the application incomplete, specifically citing issues with the second placebo-controlled trial's 8-week primary endpoint and flexible-dose paradigm. The first trial, using a 12-week endpoint and fixed-dose paradigm, was deemed adequate. Notably, both trials met their primary endpoints, and the FDA didn't question the positive results. In response, Axsome will conduct an additional controlled trial with a fixed-dose paradigm and 12-week primary endpoint, planned to start in Q4 2025. The drug aims to address approximately 17 million U.S. fibromyalgia patients' needs, having shown promising results in improving pain, function, and fatigue symptoms.

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

• William Blair 45th Annual Growth Stock Conference - June 3, 2025, at 10:40 a.m. CT in Chicago
• Jefferies Global Healthcare Conference - June 5, 2025, at 2:35 p.m. ET in New York
• Goldman Sachs 46th Annual Global Healthcare Conference - June 9, 2025, at 2:40 p.m. ET in Miami Beach

Live webcasts will be available on Axsome's website, with replays accessible for approximately 30 days after each event.

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.