Axsome Therapeut Stock Price, News & Analysis

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.

Axsome Therapeutics announced the FDA has accepted its New Drug Application (NDA) for AXS-05 to treat major depressive disorder (MDD), granting it Priority Review. This designation aims to accelerate the review process to a six-month timeline, with a target action date set for August 22, 2021. AXS-05, an investigational NMDA receptor antagonist, has shown statistically significant improvements in clinical trials. The FDA previously recognized AXS-05 with Breakthrough Therapy Designation for MDD and Alzheimer’s disease agitation.

Axsome Therapeutics (NASDAQ: AXSM) reported its financial results for Q4 and FY 2020, highlighting significant achievements including the submission of New Drug Applications (NDAs) for AXS-05 in major depressive disorder and AXS-07 for migraines. The company has received FDA Breakthrough Therapy designations for both drugs. Despite a net loss of $102.9 million, cash reserves stood at $183.9 million as of December 31, 2020, which is expected to support operations through 2024. Axsome is focused on regulatory activities and commercialization strategies for its CNS product pipeline.

Axsome Therapeutics (NASDAQ: AXSM) will participate in two investor conferences. The 10th Annual SVB Leerink Global Healthcare Conference is scheduled for February 24, 2021 at 2:20 PM Eastern Time, featuring CEO Herriot Tabuteau in a virtual chat. The Cowen 41st Annual Health Care Conference will take place on March 1, 2021 at 11:00 AM Eastern Time, again with Dr. Tabuteau. Webcasts of these events will be available on the company’s website.

Axsome is developing innovative therapies for CNS disorders, with investigational candidates including AXS-05, AXS-07, among others.