Axsome Therapeutics, Inc - AXSM STOCK NEWS

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.

Jazz Pharmaceuticals has successfully completed the divestiture of Sunosi (solriamfetol) in the U.S. to Axsome Therapeutics for an upfront payment of $53 million. Jazz will receive royalties of high single-digit on U.S. net sales for current indications and mid-single-digit for future indications. This transaction allows Jazz to focus on strategic areas for sustainable growth, as stated by CEO Bruce Cozadd. The ex-U.S. transaction is expected to close within 60 days, enhancing Jazz's commitment to operational excellence and shareholder value.

Axsome Therapeutics (AXSM) reported financial results for Q1 2022, with R&D expenses at $12.6 million, down from $16.6 million in Q1 2021. General and administrative expenses surged to $25.7 million, up from $11.2 million. The company posted a net loss of $39.6 million, or $(1.03) per share, compared to a loss of $29.3 million, or $(0.78) per share, a year earlier. Axsome's NDA for AXS-05 in major depressive disorder is under Priority Review, with potential FDA action expected in Q2 2022. Key milestones for 2022 include AXS-07 NDA resubmission and AXS-14 NDA submission in 2023.