Axsome Therapeut Stock Price, News & Analysis

Axsome Therapeutics (NASDAQ: AXSM) has announced an agreement with Sandoz Inc. to dismiss the patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation was pending in the U.S. District Court for the District of New Jersey and stemmed from Sandoz's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic equivalent of Sunosi in the United States. As part of the agreement, Sandoz has withdrawn its ANDA for a generic equivalent of Sunosi, resulting in the dismissal of the litigation without prejudice.

Axsome Therapeutics (NASDAQ: AXSM) reported strong Q2 2024 financial results, with total net product revenue of $87.2 million, up 87% year-over-year. Auvelity sales grew 135% to $65.0 million, while Sunosi revenue increased 16% to $22.1 million. The company resubmitted its NDA for AXS-07 in migraine and expects to submit an NDA for AXS-14 in fibromyalgia in Q3 2024. Axsome anticipates topline results from multiple Phase 3 trials in H2 2024, including studies of AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD. Despite strong revenue growth, the company reported a net loss of $79.3 million for Q2 2024, compared to $67.2 million in Q2 2023, primarily due to increased R&D and SG&A expenses.

Axsome Therapeutics (NASDAQ: AXSM), a leading biopharmaceutical company specializing in CNS disorder treatments, announced it will report its Q2 2024 financial results on August 5, 2024, before U.S. markets open. The management will host a conference call at 8:00 a.m. ET to discuss the results and provide a business update. Investors can join the call via a toll-free number or access a live webcast through the company's website. A recording will be available for 30 days post-event.

Axsome Therapeutics (NASDAQ: AXSM) announced a settlement with Unichem Laboratories regarding patent litigation for Sunosi® (solriamfetol). The litigation arose after Unichem filed for FDA approval to market a generic version of Sunosi in the U.S. per an Abbreviated New Drug Application. The settlement allows Unichem to sell its generic version starting June 30, 2042, with possible earlier entry under specific conditions. Additionally, the date could be extended for pediatric exclusivity. The agreement will be reviewed by the U.S. Federal Trade Commission and the Department of Justice. Similar litigation with other parties continues in the District of New Jersey.

Axsome Therapeutics (NASDAQ: AXSM) announced its participation in the American Migraine Foundation's efforts for Migraine & Headache Awareness Month in June 2024. This initiative aims to raise awareness about unmet treatment needs for the 37 million Americans suffering from migraines, which cause significant physical, emotional, and economic impacts. The American Migraine Foundation emphasizes the importance of education, support, community, and research to improve patient outcomes and societal attitudes toward migraines. Notably, 70% of migraine sufferers are dissatisfied with current treatments, and nearly 80% are open to trying new therapies.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company specializing in central nervous system (CNS) disorders, announced its support for Alzheimer’s & Brain Awareness Month this June. The initiative aims to raise awareness about Alzheimer’s disease (AD), a progressive neurodegenerative disorder affecting nearly 7 million individuals in the U.S., a number that could double by 2060. Axsome's headquarters at One World Trade Center will be illuminated in purple on June 21, 2024, symbolizing AD awareness.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company specializing in therapies for CNS disorders, announced participation in two investor conferences. These events include the William Blair 44th Annual Growth Stock Conference on June 5 in Chicago, where CEO Herriot Tabuteau, MD, will present a corporate overview, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 12 in Miami Beach, where Axsome leadership will conduct investor meetings. A live webcast of the William Blair presentation will be available on the company's website.

On May 29, 2024, Axsome Therapeutics (NASDAQ: AXSM) announced significant findings on solriamfetol at the SLEEP 2024 conference, held from June 1-5, 2024, in Houston, Texas. The presentations highlighted solriamfetol's positive effects on cognitive function in patients with Obstructive Sleep Apnea (OSA) and narcolepsy, particularly those experiencing Excessive Daytime Sleepiness (EDS). Key findings from the SHARP study, led by Professor Hans Van Dongen, demonstrated improvements in executive function, memory, and processing speed. Presentations included two oral plenary sessions and multiple poster sessions, emphasizing solriamfetol's impact on various cognitive metrics and real-world applications.

Axsome Therapeutics (NASDAQ: AXSM) will present data from its CNS disorder therapies at the American Society of Clinical Psychopharmacology Annual Meeting from May 28-31, 2024, in Miami Beach, Florida. Key presentations include:

1. Post-hoc analyses of Auvelity® demonstrating significant improvements in anhedonic and daily functioning in major depressive disorder (MDD) patients.

2. Data on AXS-05's clinical profile for treating Alzheimer's disease agitation, showcasing promising results from the Phase 2/3 development program.

3. Findings on Solriamfetol's efficacy in enhancing cognitive performance in sleep apnea patients from both preclinical and clinical studies.