Axsome Therapeut - AXSM STOCK NEWS

Axsome Therapeutics reported Q3 2022 net sales of $16.8 million from Sunosi, marking a significant milestone since the product's acquisition. The company launched Auvelity on October 20, 2022, following FDA approval. Operating expenses rose, with R&D expenses at $14.9 million and SG&A at $40.9 million.

The net loss was $44.8 million or $(1.07) per share. Axsome maintains a strong cash position of $227.5 million, projected to fund operations into 2025. Key clinical trials and product candidates are progressing, with notable milestones ahead.

Axsome Therapeutics (NASDAQ: AXSM) announced the launch of AUVELITY™, a novel oral treatment for Major Depressive Disorder (MDD) in adults, coinciding with a ceremonial bell ringing at NASDAQ on October 27, 2022. AUVELITY is an NMDA receptor antagonist that combines dextromethorphan and bupropion, receiving Breakthrough Therapy designation from the FDA. Additionally, Axsome highlighted the relaunch of Sunosi, enhancing its position in the CNS therapy market. The company remains committed to advancing its robust pipeline of treatments for mental health conditions.

Axsome Therapeutics (NASDAQ: AXSM) will report its Q3 2022 financial results on November 7, 2022, before U.S. market opening. A conference call will take place at 8:00 AM ET for management to discuss results and provide business updates. Interested parties can join the call by dialing (877) 405-1239 or via a live webcast on the company’s website. Axsome focuses on developing novel CNS therapies, emphasizing its commitment to enhancing patient outcomes. Forward-looking statements pertain to potential market and regulatory challenges affecting product candidates.

Axsome Therapeutics has launched AUVELITY™, an innovative oral treatment for major depressive disorder (MDD) in adults, marked as the first NMDA receptor antagonist of its kind. Approved by the FDA on August 18, 2022, AUVELITY demonstrates rapid symptom relief, showing statistically significant improvement compared to placebo starting at one week. This breakthrough treatment addresses the urgent need for effective therapies in a population with over 20 million affected annually. Comprehensive patient support, including savings programs and telehealth services, are also available to facilitate access for patients and healthcare providers.

Axsome Therapeutics announced that Sunosi met its primary endpoint in the SHARP study, significantly improving cognitive function in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA). Key findings included a statistically significant improvement in cognitive function as measured by the DSST RBANS (p=0.009) and patient-reported outcomes (p=0.002). Additionally, Sunosi reduced EDS symptoms (p=0.004). The study was conducted as a randomized, double-blind, placebo-controlled trial involving 59 patients. The company plans to discuss results with the FDA.

Axsome Therapeutics (NASDAQ: AXSM) announced plans to resubmit its New Drug Application (NDA) for AXS-07, aimed at treating acute migraine, after a Type A meeting with the FDA. The resubmission is expected in Q3 2023, addressing issues from a prior Complete Response Letter, particularly in chemistry, manufacturing, and controls (CMC). No new clinical trials are required, and the NDA is anticipated to receive a Class 2 designation for a six-month review. AXS-07, a combination of MoSEIC meloxicam and rizatriptan, could offer a significant treatment option for the over 37 million Americans suffering from migraines.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced that Dr. Herriot Tabuteau, CEO, will participate in a fireside chat at the Ladenburg Thalmann Healthcare Conference on September 29, 2022, at 9:30 AM ET. The conference is set to take place at the Sofitel New York City. Interested individuals can view a live webcast and archive of the event on the company's website in the 'Investors' section. Axsome focuses on developing novel therapies for central nervous system disorders, aiming to improve treatment options and patient outcomes.

Axsome Therapeutics (NASDAQ: AXSM) will have CEO Herriot Tabuteau participate in a virtual fireside chat at the Cowen 2nd Annual Novel Mechanisms in Neuropsychiatry Summit on September 19, 2022, at 12:05 PM ET. The event can be accessed via live webcast and archived on their website. Axsome focuses on developing innovative therapies for central nervous system disorders, aiming to provide effective treatment options for patients with limited existing therapies. For more details, visit axsome.com.

Axsome Therapeutics (NASDAQ: AXSM) has initiated the ADVANCE-2 trial, enrolling its first patient for AXS-05, targeting Alzheimer’s disease agitation. This Phase 3 study aims to investigate the efficacy and safety of AXS-05 compared to a placebo, involving about 350 participants over five weeks, with the Cohen-Mansfield Agitation Inventory as the primary measure. AXS-05, an NMDA receptor antagonist, holds FDA Breakthrough Therapy designation for treating agitation. Currently, no FDA-approved treatments exist for this condition, highlighting the potential impact of AXS-05.