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 leading biopharmaceutical company dedicated to developing innovative therapies for the treatment of central nervous system (CNS) disorders. Headquartered in New York City, Axsome's mission is to address unmet medical needs and improve the lives of patients suffering from CNS conditions.
The company's portfolio includes a mix of clinical-stage and research-stage product candidates, with a primary focus on CNS disorders such as depression, migraine, narcolepsy, and Alzheimer's disease. Axsome's pipeline features notable candidates like AXS-05 for major depressive disorder, AXS-07 for migraine, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. These therapies are being developed to provide novel treatment options where current solutions are limited or inadequate.
Axsome manages its business as a single operating segment, emphasizing the development and delivery of groundbreaking CNS therapies. The company has made significant strides in advancing its clinical programs, with several candidates progressing through various stages of clinical trials. Recent achievements include positive data readouts from clinical studies and successful end-of-phase meetings with regulatory bodies, positioning Axsome closer to potential market approvals.
Financially, Axsome maintains a solid foundation through strategic collaborations, public offerings, and partnerships. These financial maneuvers have enabled sustained investment in research and development, essential for driving innovation and bringing new therapies to market.
Axsome's commitment to transforming the treatment landscape for CNS disorders is underscored by its active engagement with the medical community, participation in scientific conferences, and continuous updates to investors and stakeholders. The company’s proactive communication strategy ensures transparency and keeps all interested parties informed about ongoing developments.
For the latest updates, investors and media can reach out to Mark Jacobson, Chief Operating Officer, or Darren Opland, Director of Corporate Communications, at Axsome's headquarters in New York City. More information is available on the company’s website, www.axsome.com.
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.
Axsome Therapeutics (NASDAQ: AXSM) announced a Complete Response Letter (CRL) from the FDA regarding its NDA for AXS-07, aimed at treating acute migraines. The CRL raised no efficacy or safety concerns but identified the need for additional chemistry, manufacturing, and controls (CMC) data. Axsome plans to engage with the FDA to resolve these outstanding items and aims to resubmit its application promptly. AXS-07 is supported by positive Phase 3 trial results demonstrating significant migraine pain relief.
Axsome Therapeutics (NASDAQ: AXSM) plans to announce its first-quarter 2022 financial results on May 2, 2022, prior to market opening. The company will host a conference call at 8:00 AM ET on the same day to discuss the results and provide a business update. As a biopharmaceutical company, Axsome focuses on developing innovative therapies for central nervous system disorders, aiming to significantly improve patient outcomes.
Axsome Therapeutics has announced its acquisition of Sunosi from Jazz Pharmaceuticals, a strategic move set to bolster Axsome's global commercial presence.
Sunosi is a FDA-approved dual-acting dopamine and norepinephrine reuptake inhibitor aimed at improving wakefulness in adults suffering from excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea.
The transaction, valued at $53 million, is expected to be breakeven in 2023 and could generate over $1 billion in peak revenues, enhancing Axsome's pipeline ahead of potential launches of AXS-05 and AXS-07.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a virtual fireside chat at the 1st Annual Needham Virtual Neuroscience Forum on March 16, 2022, at 10:15 AM ET. Interested parties can access a live webcast on the company’s website. Axsome focuses on developing therapies for central nervous system (CNS) disorders with limited treatment options, aiming to improve patient lives and provide new options for physicians.
FAQ
What is the current stock price of Axsome Therapeut (AXSM)?
What is the market cap of Axsome Therapeut (AXSM)?
What does Axsome Therapeutics, Inc. do?
Where is Axsome Therapeutics based?
What are some key products in Axsome's pipeline?
What recent achievements has Axsome made?
How does Axsome manage its business operations?
How does Axsome maintain its financial health?
Who are the key contacts for investors and media?
What is the mission of Axsome Therapeutics?
What kind of disorders does Axsome focus on?
How can I stay updated on Axsome's latest news and developments?
