Axsome Therapeutics, Inc - AXSM STOCK NEWS

Axsome Therapeutics, Inc. (NASDAQ: AXSM) has enrolled the first patient in the SYMPHONY trial, a Phase 3 study assessing AXS-12 for narcolepsy. This randomized, double-blind trial aims to evaluate AXS-12's efficacy and safety in about 90 patients, focusing on cataplexy attack frequency. Topline results are expected in early 2023. AXS-12, a selective norepinephrine reuptake inhibitor, has received Orphan Drug Designation from the FDA. The advancement into Phase 3 underscores Axsome's dedication to developing therapies for serious CNS disorders affecting patients' quality of life.

Axsome Therapeutics (NASDAQ: AXSM) announced that the FDA has accepted its New Drug Application (NDA) for AXS-07 to treat acute migraine, with a target decision date of April 30, 2022. AXS-07 is an investigational drug combining MoSEIC meloxicam and rizatriptan, proven in Phase 3 trials to significantly alleviate migraine pain. Over 37 million Americans suffer from migraines, leading to substantial healthcare costs. The company's CEO emphasized the NDA acceptance as a pivotal step toward providing a new treatment option for those affected by this debilitating condition.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced that the FDA will not complete its review of the new drug application (NDA) for AXS-05, aimed at treating major depressive disorder, by the PDUFA target date of August 22, 2021. The FDA did not request additional information, indicating ongoing review without further obstacles. AXS-05 is an investigational drug with a novel mechanism of action, protected by over 100 patents. The company is focused on developing therapies for CNS conditions, meeting significant unmet needs in patients suffering from major depressive disorder.

Axsome Therapeutics (NASDAQ: AXSM) reported its second quarter financial results on August 9, 2021. The company faces potential delays in the approval of AXS-05 due to identified deficiencies by the FDA. However, AXS-07's NDA for migraine treatment was filed, and a Phase 3 trial for AXS-12 in narcolepsy is expected to start this quarter. Financially, Axsome's R&D expenses rose to $14.5 million, while G&A expenses surged to $16.3 million, leading to a net loss of $32.3 million for the quarter. Cash reserves decreased to $141.2 million from $183.9 million.

Axsome Therapeutics announced that AXS-05 met its primary endpoint in the Phase 2 MERIT trial, significantly delaying relapse of depressive symptoms in patients with treatment-resistant depression (p=0.002). The drug also achieved a secondary endpoint, showing a 0.0% relapse rate compared to 36.4% for the placebo group (p=0.004). AXS-05 was well tolerated, with limited adverse events reported. A new drug application is under Priority Review by the FDA, with a target action date of August 22, 2021.

Axsome Therapeutics (NASDAQ: AXSM) announced a conference call set for August 9, 2021, at 8:00 AM ET to discuss its second-quarter financial results and provide a business update. The results will be reported before U.S. markets open. Interested participants can join the call via a dedicated phone line or through a webcast on Axsome's website. The company is focused on developing innovative therapies for central nervous system disorders with an emphasis on improving patient outcomes. Forward-looking statements highlight various risks related to clinical trials and regulatory approvals.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced plans to submit a New Drug Application (NDA) for AXS-14, a norepinephrine reuptake inhibitor, for fibromyalgia management after a meeting with the FDA. This submission is expected in Q4 2022, contingent on successful manufacturing completion. Results from two trials demonstrated AXS-14's efficacy, showing significant improvements in pain scores and fatigue. Fibromyalgia affects approximately 5 million Americans, with limited treatment options available.

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.