Axsome Therapeutics, Inc - AXSM STOCK NEWS

Axsome Therapeutics reported its third quarter 2021 financial results, highlighting the advancement of its CNS products. The FDA is currently reviewing the NDA for AXS-05 in depression, while the NDA for AXS-07 in migraine has been accepted. The company is preparing for potential launches if approved. Axsome's R&D expenses decreased to $13.2 million, while G&A expenses spiked to $20.2 million, reflecting pre-commercial activities. The net loss rose to $34.9 million. Cash reserves stand at $114.6 million, sufficient to fund operations through 2024.

Axsome Therapeutics (NASDAQ: AXSM) will report its Q3 2021 financial results on November 8, 2021, prior to market opening. A conference call will follow at 8:00 AM ET the same day, aimed at discussing these results along with a business update. Interested participants can join by dialing (844) 698-4029 (domestic) or (647) 253-8660 (international), using conference ID 6365926. The event will also be available via a live webcast on the Company's website, with a recording accessible for 30 days post-event.

Axsome Therapeutics announces an amendment to its term loan facility with Hercules Capital, increasing the loan size to $300 million. Upon potential FDA approval of AXS-05 for major depressive disorder, $100 million will be available immediately. The agreement extends the loan's maturity to October 2026 and interest-only payments up to 60 months. This capital will support the anticipated launches of both AXS-05 and AXS-07, enhancing financial flexibility for the company’s critical therapies.

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.