Axsome Therapeutics, Inc - AXSM STOCK NEWS

Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced its financial results for Q1 2021, revealing a net loss of $29.3 million, or $(0.78) per share. R&D expenses decreased to $16.6 million, while G&A expenses rose to $11.2 million due to pre-commercial activities. The company successfully filed its NDA for AXS-05 for major depressive disorder, receiving FDA Priority Review, with a PDUFA date set for August 22, 2021. Axsome plans to submit its NDA for AXS-07 for migraine this quarter, and is ramping up commercial preparations for potential product launches in H2 2021.

Axsome Therapeutics (NASDAQ: AXSM) will release its Q1 2021 financial results on May 10, 2021, before U.S. market opening. Management will host a conference call at 8:00 AM ET to discuss the results and provide updates. The event can be accessed through a toll-free number or via live webcast on the company's website. Axsome focuses on developing novel therapies for CNS disorders and currently has five clinical-stage candidates. The company highlights its commitment to providing life-changing medicines despite challenges in clinical trials and regulatory approvals.

Axsome Therapeutics announced the FDA has accepted its New Drug Application (NDA) for AXS-05 to treat major depressive disorder (MDD), granting it Priority Review. This designation aims to accelerate the review process to a six-month timeline, with a target action date set for August 22, 2021. AXS-05, an investigational NMDA receptor antagonist, has shown statistically significant improvements in clinical trials. The FDA previously recognized AXS-05 with Breakthrough Therapy Designation for MDD and Alzheimer’s disease agitation.

Axsome Therapeutics (NASDAQ: AXSM) reported its financial results for Q4 and FY 2020, highlighting significant achievements including the submission of New Drug Applications (NDAs) for AXS-05 in major depressive disorder and AXS-07 for migraines. The company has received FDA Breakthrough Therapy designations for both drugs. Despite a net loss of $102.9 million, cash reserves stood at $183.9 million as of December 31, 2020, which is expected to support operations through 2024. Axsome is focused on regulatory activities and commercialization strategies for its CNS product pipeline.

Axsome Therapeutics (NASDAQ: AXSM) will participate in two investor conferences. The 10th Annual SVB Leerink Global Healthcare Conference is scheduled for February 24, 2021 at 2:20 PM Eastern Time, featuring CEO Herriot Tabuteau in a virtual chat. The Cowen 41st Annual Health Care Conference will take place on March 1, 2021 at 11:00 AM Eastern Time, again with Dr. Tabuteau. Webcasts of these events will be available on the company’s website.

Axsome is developing innovative therapies for CNS disorders, with investigational candidates including AXS-05, AXS-07, among others.

Axsome Therapeutics (NASDAQ: AXSM) will report its fiscal year 2020 financial results on March 1, 2021, before U.S. markets open. A conference call is scheduled for 8:00 AM Eastern Time to discuss these results and provide a business update. The company is known for its innovative CNS disorder therapies, with five clinical-stage candidates including AXS-05 and AXS-07. These investigational drugs target major depressive disorder and migraine treatment, respectively. For more details, visit Axsome's official website.

Axsome Therapeutics has initiated the ACCORD Phase 3 trial to evaluate AXS-05 for treating Alzheimer’s disease agitation. AXS-05, an investigational NMDA receptor antagonist, aims to address a significant unmet need as no treatments are currently approved for this condition. The trial will include an open-label stabilization phase followed by a randomized double-blind period. Topline results are expected in late 2022, supported by previous positive findings from the ADVANCE trial. The FDA has granted Breakthrough Therapy designations for AXS-05, underscoring its potential impact.

Axsome Therapeutics (NASDAQ: AXSM) announced positive results from the Phase 3 MOVEMENT trial of AXS-07, a novel migraine treatment. Over 21,000 migraine attacks were treated, showcasing a rapid pain relief rate of approximately 70% at two hours and about 40% achieving pain freedom. Durable relief was noted, with 85% of patients not requiring rescue medications within 48 hours. The long-term safety profile was consistent with earlier controlled trials. The company expects to submit a New Drug Application (NDA) for AXS-07 in Q1 2021.

Axsome Therapeutics reported promising results from the open-label Phase 2 COMET-SI trial of AXS-05, targeting major depressive disorder (MDD) with suicidal ideation. The trial showed a 67.6% reduction in MADRS-SI scores by Week 1, with 60% of patients achieving resolution of suicidal ideation. By Week 4, reductions reached 82.4% and 78% of patients were free of suicidal thoughts. Functional improvements were notable with 51.4% of patients improving significantly by Week 1. AXS-05 was well tolerated and has FDA Breakthrough designation for MDD treatment, enhancing its market potential.