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 biopharmaceutical company focused on central nervous system (CNS) conditions, and its news flow reflects both commercial performance and clinical development across this neuroscience portfolio. On this page, readers can follow AXSM news related to its FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as updates on its late-stage and other development programs.
Company announcements frequently cover net product revenue for AUVELITY, SUNOSI, and SYMBRAVO, as reported in quarterly financial results and preliminary revenue updates. These releases, often furnished to the SEC via Form 8-K, provide insight into prescription trends, payer coverage metrics, and the contribution of each product to Axsome’s overall revenue base.
Axsome’s news also highlights key clinical and regulatory milestones. Examples include initiation of the FORWARD Phase 3 trial of AXS-14 in fibromyalgia, FDA acceptance and Priority Review of a supplemental New Drug Application for AXS-05 in Alzheimer’s disease agitation, and pre-NDA meeting outcomes supporting an NDA submission for AXS-12 in narcolepsy. Additional items describe progress of solriamfetol in multiple Phase 3 programs and the acquisition of AZD7325 for potential use in epilepsy.
Investors and followers of AXSM stock can use this news feed to monitor earnings releases, pipeline data presentations at scientific meetings, regulatory designations, business development transactions, and Axsome’s participation in healthcare and biopharma investor conferences. Bookmarking this page allows for efficient tracking of how Axsome advances its CNS portfolio and communicates with the market over time.
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.
Axsome Therapeutics (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a virtual fireside chat at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 10:30 AM Eastern Time. A live webcast and archive will be available on the Company’s website. Axsome focuses on developing innovative therapies for central nervous system disorders, aiming to improve treatment options for patients. The Company is committed to transforming CNS treatment through its novel mechanisms of action.
Axsome Therapeutics (NASDAQ: AXSM) announced its fourth-quarter and full-year financial results for 2021, highlighting a net loss of $34 million, or $(0.90) per share, compared to a loss of $29.2 million, or $(0.78) per share, in Q4 2020. R&D expenses decreased to $13.8 million, attributed to the conclusion of clinical trials. The company is advancing its pipeline, with NDAs for AXS-05 for major depressive disorder and AXS-07 for migraines under FDA review, with a PDUFA date of April 30, 2022. Axsome ended 2021 with $86.5 million in cash, having accessed $20 million from its ATM equity facility in February 2022.
Axsome Therapeutics (NASDAQ: AXSM) will report its Q4 and fiscal year 2021 financial results on March 1, 2022, before U.S. market opening. A conference call is scheduled for 8:00 AM ET on the same day to discuss these results and provide a business update. The event can be accessed via a live webcast on the company’s website. Axsome is focused on developing novel therapies for central nervous system disorders. The press release includes forward-looking statements regarding clinical trial outcomes and regulatory approvals, highlighting potential risks and uncertainties.
Axsome Therapeutics (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will engage in a virtual fireside chat during the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 1:40 PM ET. The event will focus on the company’s innovative therapies for central nervous system disorders. A live webcast and archive will be available on the company’s website. Axsome is dedicated to developing unique treatment options to enhance patient care, targeting conditions with limited therapies.