Welcome to our dedicated page for Axsome Therapeut news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeut stock.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a biopharmaceutical company focused on central nervous system (CNS) conditions, and its news flow reflects both commercial performance and clinical development across this neuroscience portfolio. On this page, readers can follow AXSM news related to its FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as updates on its late-stage and other development programs.
Company announcements frequently cover net product revenue for AUVELITY, SUNOSI, and SYMBRAVO, as reported in quarterly financial results and preliminary revenue updates. These releases, often furnished to the SEC via Form 8-K, provide insight into prescription trends, payer coverage metrics, and the contribution of each product to Axsome’s overall revenue base.
Axsome’s news also highlights key clinical and regulatory milestones. Examples include initiation of the FORWARD Phase 3 trial of AXS-14 in fibromyalgia, FDA acceptance and Priority Review of a supplemental New Drug Application for AXS-05 in Alzheimer’s disease agitation, and pre-NDA meeting outcomes supporting an NDA submission for AXS-12 in narcolepsy. Additional items describe progress of solriamfetol in multiple Phase 3 programs and the acquisition of AZD7325 for potential use in epilepsy.
Investors and followers of AXSM stock can use this news feed to monitor earnings releases, pipeline data presentations at scientific meetings, regulatory designations, business development transactions, and Axsome’s participation in healthcare and biopharma investor conferences. Bookmarking this page allows for efficient tracking of how Axsome advances its CNS portfolio and communicates with the market over time.
Axsome Therapeutics (NASDAQ: AXSM) will report its Q2 2022 financial results on August 9, 2022, before U.S. market opening. A conference call is scheduled for 8:00 AM ET to discuss these results and provide a business update. Axsome is focused on developing innovative therapies for CNS disorders, showcasing its commitment to transform treatment options in this field. Investors can access the conference call via a toll-free number or through a live webcast on the company's website, with a recording available for 30 days post-event.
Axsome Therapeutics (NASDAQ: AXSM) hosted a virtual event on June 28, 2022, to update investors on Sunosi® (solriamfetol), the first dual-acting DNRI approved for excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. Key opinion leaders discussed clinical aspects and future indications of Sunosi, while management shared commercial and development strategies. Sunosi received FDA approval on March 20, 2019, and has orphan drug designation for narcolepsy, indicating potential growth in this market segment.
Axsome Therapeutics (NASDAQ: AXSM) announced a virtual event on June 28, 2022, at 9:00 AM EDT to update investors on Sunosi® (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor. Sunosi is the first medication approved for improving wakefulness in adults with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). The event will feature clinical insights from physician experts and covers commercial activities. The live webcast can be accessed through Axsome's website, with a replay available for 30 days.
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Axsome Therapeutics announced positive results from the GEMINI Phase 3 trial of AXS-05 for major depressive disorder (MDD). The treatment showed rapid and significant improvement in anhedonia symptoms, with a notable decrease on the MADRS anhedonia subscale compared to placebo (-9.70 vs -7.22 points; p=0.001). Improvements were observed from the first week of treatment. AXS-05 is a novel NMDA receptor antagonist and is under FDA review for MDD. These findings were presented at the ASCP 2022 Annual Meeting.
Axsome Therapeutics announced positive long-term results from the EVOLVE trial of AXS-05, focusing on major depressive disorder (MDD). The study demonstrated significant, sustained improvements in depressive symptoms, anxiety, and overall functioning over 12 months. Key statistics include a 24.5-point improvement in the MADRS score and 68% remission rate at 12 months. AXS-05 showed a favorable safety profile, consistent with earlier trials. This presentation was part of the American Society of Clinical Psychopharmacology Annual Meeting, highlighting AXS-05's potential as an effective treatment for patients with treatment-resistant depression.
AXS-05 (dextromethorphan-bupropion) has shown rapid, significant antidepressant efficacy compared to placebo, as highlighted in the GEMINI Phase 3 trial results published on May 30, 2022. The trial included 327 patients with moderate to severe major depressive disorder (MDD) and demonstrated a substantial reduction in depressive symptoms, particularly noted in the Montgomery-Åsberg Depression Rating Scale (MADRS). Notably, AXS-05 achieved a 39.5% remission rate at week 6. The drug maintained a favorable safety profile, with most adverse events being mild. A new drug application (NDA) is under FDA review.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced the publication of results from its pivotal ASCEND Phase 2 clinical trial of AXS-05 (dextromethorphan-bupropion) for major depressive disorder (MDD). The study revealed that AXS-05 demonstrated statistically significant improvements in depressive symptoms compared to bupropion, with a mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) score of -13.7 vs. -8.8 points. Remission rates at week 6 were 46.5% for AXS-05 versus 16.2% for bupropion. The results support the ongoing NDA review by the FDA for AXS-05.
Axsome Therapeutics has completed its acquisition of Sunosi from Jazz Pharmaceuticals, marking a significant shift towards becoming a commercial neuroscience company. Sunosi, a dual-acting dopamine and norepinephrine reuptake inhibitor, is FDA-approved for improving wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. The drug boasts 96% insurance coverage, providing access to approximately 253 million lives. In clinical trials, Sunosi demonstrated significant efficacy in reducing daytime sleepiness and increasing wakefulness.
Axsome Therapeutics has completed the U.S. acquisition of Sunosi (solriamfetol) from Jazz Pharmaceuticals, enhancing its CNS product portfolio. Sunosi, approved by the FDA for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea, boasts broad insurance coverage for 96% of commercial lives. The acquisition positions Axsome as a commercial neuroscience company, supporting patient access through comprehensive affordability programs. Clinical trials have shown significant efficacy for Sunosi, including up to 22% reduction in daytime sleepiness and increased wakefulness. Axsome plans further research into Sunosi.