Axsome Therapeut Stock Price, News & Analysis

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 42^nd 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.