Welcome to our dedicated page for Axsome Therapeutics news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeutics 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.
Axsome Therapeutics announced positive results from the Phase 2 COMET-TRD trial for AXS-05 in patients with treatment-resistant depression (TRD). The trial demonstrated that after 6 weeks, 67% of patients showed a response in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Furthermore, 64% reported significant improvements in functioning per the Sheehan Disability Scale. AXS-05 was well-tolerated, with a safety profile consistent with past studies. The positive outcomes underscore AXS-05's potential as a novel treatment for TRD.
Axsome Therapeutics (NASDAQ: AXSM) reported positive results from the Phase 3 COMET trial of AXS-05 in major depressive disorder (MDD). After 12 months, 73% of patients showed a substantial improvement in depressive symptoms, with 55% showing improved functioning at 2 weeks. Long-term efficacy was sustained, with a favorable safety profile and no new safety signals detected. The company plans to submit a New Drug Application (NDA) for AXS-05 in January 2021. AXS-05, an NMDA receptor antagonist, demonstrated overall efficacy even in patients unresponsive to prior antidepressants.
Axsome Therapeutics (NASDAQ: AXSM) announced significant advancements in its clinical pipeline, with NDA submissions for AXS-05 in major depressive disorder (MDD) expected in January 2021 and for AXS-07 in migraine slated for 1Q 2021. Positive results were reported from several Phase 2 trials, with expected efficacy data for AXS-05 by 4Q 2020. The company secured a $225 million term loan, enhancing its financial position with nearly $400 million in available resources. The launch readiness of its Digital-Centric Commercialization platform aims to optimize market engagement for upcoming product launches.
Axsome Therapeutics has announced a strategic partnership with Veeva Systems to enhance its Digital-Centric Commercialization (DCC™) platform. This collaboration aims to support the potential launch of two CNS investigational drugs, AXS-05 for depression and AXS-07 for migraine, expected next year. Veeva will provide its cloud solutions, including Veeva CRM and MyVeeva for Doctors, to improve customer engagement. The partnership will also grant Axsome early access to new digital technologies and industry insights, positioning it to optimize physician-patient interactions and promotional efforts.
Axsome Therapeutics (NASDAQ: AXSM) announced data presentation from the ADVANCE-1 trial of AXS-05 for Alzheimer's disease agitation at the 13th Clinical Trials on Alzheimer’s Disease conference, scheduled for November 4-7, 2020. AXS-05, an investigational NMDA receptor antagonist, aims to address critical needs in CNS disorders. The oral presentation will detail the efficacy and safety of AXS-05, with a follow-up Q&A. AXS-05 holds multiple regulatory designations, emphasizing its potential to improve treatment outcomes for Alzheimer's patients.
Axsome Therapeutics (NASDAQ: AXSM) will release its third quarter 2020 financial results on November 5, 2020, prior to the U.S. market opening. The management team will host a conference call at 8:00 AM Eastern Time to discuss these results and provide a business update. Axsome develops therapies for central nervous system disorders and has five clinical-stage candidates, including AXS-05 for major depressive disorder and AXS-07 for migraine. The company emphasizes the potential for accelerated approval of its products, pending successful clinical trials.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) has secured a $225 million term loan facility with Hercules Capital, strengthening its balance sheet ahead of the commercial launches of AXS-05 for major depressive disorder and AXS-07 for migraine. This non-dilutive capital extends Axsome's cash runway into at least 2024. The loan includes an initial $60 million drawdown, with further funds contingent on product approvals and sales criteria. Interest starts at 9.15%, with maturity in October 2025. This financing will support Axsome's ongoing CNS product development.
Axsome Therapeutics (NASDAQ: AXSM) has secured a $225 million term loan facility with Hercules Capital to enhance its balance sheet ahead of major product launches. This non-dilutive funding extends its cash runway into at least 2024, supporting the commercial launches of AXS-05 for major depressive disorder and AXS-07 for migraine. Upon closing, Axsome drew $50 million and aims to access further tranches based on product approvals and sales criteria. The loan, maturing in October 2025, includes a variable interest rate currently at 9.15% and will aid in advancing its additional CNS pipeline.
Axsome Therapeutics (NASDAQ: AXSM) announced promising results from the MOMENTUM Phase 3 trial for AXS-07, an investigational oral medication for acute migraine treatment. AXS-07 showed a median time to pain relief nearly three times faster than rizatriptan (1.5 vs. 4.0 hours, p<0.001). Additionally, only 21.2% of AXS-07 patients experienced pain relapse over 48 hours, compared to 45.2% with rizatriptan (p=0.001). AXS-07 demonstrated safety, with common adverse effects similar to placebo. The drug is protected by 44 patents until 2036, emphasizing its market potential.
Axsome Therapeutics (NASDAQ: AXSM) announced an expedited development plan for AXS-12, a novel treatment for narcolepsy, following a Breakthrough Therapy meeting with the FDA. The plan includes a Phase 3 trial to support an NDA filing, alongside data from the completed Phase 2 CONCERT trial. AXS-12 aims to reduce cataplexy attacks and improve patient cognitive function and daytime alertness. The initiation of the Phase 3 trial is expected in 1Q 2021, leveraging a large safety database from reboxetine. AXS-12 has already received Breakthrough Therapy designation from the FDA.
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