Axsome Therapeut - AXSM STOCK NEWS

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.

Axsome Therapeutics (NASDAQ: AXSM) announced positive results from its FOCUS Phase 3 trial of solriamfetol for treating Attention Deficit Hyperactivity Disorder (ADHD). The trial, involving 516 adults, demonstrated statistically significant improvements in ADHD symptoms compared to placebo.

Key findings include:

• 17.7-point reduction in AISRS total score with 150mg solriamfetol vs 14.3 points for placebo (p=0.039)
• 45% mean reduction in ADHD symptoms from baseline at Week 6
• 53.5% of patients on 150mg achieved clinical response vs 41.3% on placebo
• Onset of action observed as early as Week 1
• Significant reduction in disease severity (CGI-S score)

The 300mg dose showed numerically superior results compared to placebo but wasn't statistically significant. The drug was well-tolerated with no serious adverse events reported. Axsome plans to initiate pediatric trials this year.

Axsome Therapeutics (NASDAQ: AXSM) has reached a settlement agreement with Hikma Pharmaceuticals USA regarding patent litigation over Sunosi® (solriamfetol). The litigation arose from Hikma's submission of an Abbreviated New Drug Application seeking approval for a generic version of Sunosi in the United States.

Under the settlement terms, Axsome will grant Hikma a license to sell its generic version of Sunosi starting either September 1, 2040 (if pediatric exclusivity is granted) or March 1, 2040 (if no pediatric exclusivity is granted), subject to FDA approval. The agreement will be reviewed by the U.S. Federal Trade Commission and Department of Justice. Similar patent litigation against other parties regarding Sunosi remains pending in the U.S. District Court for the District of New Jersey.

Axsome Therapeutics (NASDAQ: AXSM) has received FDA pre-NDA meeting minutes supporting a supplemental New Drug Application (sNDA) submission for AXS-05 in treating Alzheimer's disease agitation. The submission is planned for Q3 2025.

AXS-05, granted Breakthrough Therapy designation in June 2020, demonstrated significant improvement in three Phase 3 trials: ADVANCE-1 (p=0.010), ACCORD-1 (p=0.014), and ACCORD-2 (p=0.001). The drug's development program includes four Phase 3 efficacy trials and a long-term safety trial.

Safety studies involving over 300 patients treated for 6+ months and 100+ patients for 12+ months showed AXS-05 was well-tolerated, with no deaths reported and no increased risk of falls, sedation, or cognitive decline.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, has announced its participation in two major investor conferences in March 2025:

• TD Cowen 45th Annual Health Care Conference - Presenting on March 4, 2025, at 9:50 a.m. ET in Boston, MA
• Leerink Partners Global Biopharma Conference - Presenting on March 12, 2025, at 10:40 a.m. ET in Miami, FL

Investors can access live webcasts of both presentations through the 'Webcasts & Presentations' page in the Investors section of axsome.com. Replay recordings will remain available for approximately 30 days after each event.

Axsome Therapeutics (NASDAQ: AXSM) announced positive results from the EMERGE Phase 3 trial of SYMBRAVO® in migraine patients with inadequate response to oral CGRP inhibitors. The trial met its primary endpoint, demonstrating significantly greater migraine treatment response compared to oral CGRP inhibitors.

Key findings include: 47.9% of patients reported 2-hour pain freedom with SYMBRAVO versus 1.0% with oral CGRPs; 47.9% experienced 24-hour sustained pain relief compared to 16.7%; and 51.0% reported quick return to normal activities versus 11.5% with oral CGRPs. The trial enrolled 96 patients, treating 365 migraine attacks.

SYMBRAVO showed rapid onset of action, with 50.0% achieving pain relief within 2 hours, and benefits sustained through 24 and 48 hours in 78% and 75% of patients respectively. The treatment was well-tolerated, with common adverse events including fatigue and nausea (3.1% each).

Axsome Therapeutics (AXSM) reported strong financial results for Q4 and full year 2024, with total net product revenue reaching $118.8M in Q4 (66% YoY growth) and $385.7M for the full year (88% YoY growth). Auvelity sales showed impressive growth of 89% YoY to $92.6M in Q4, while Sunosi revenue grew 16% to $26.2M.

The company achieved significant milestones including FDA approval of Symbravo for acute migraine treatment, completion of Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation, and positive results from ENCORE Phase 3 trial of AXS-12 in narcolepsy. Both products are anticipated for NDA submission in 2H 2025.

Net loss for Q4 2024 was $74.9M ($1.54 per share), compared to $98.7M ($2.08 per share) in Q4 2023. Cash position stood at $315.4M as of December 31, 2024, which the company believes is sufficient to fund operations until cash flow positivity.