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AXSM up on FDA priority review to AXS-05 sNDA in Alzheimer's agitation

Shares of Axsome Therapeutics AXSM were up 22.8% on Dec. 31, after it announced that the FDA had accepted the supplemental ...
The Pharma Letter

FDA grants Axsome’s AXS-05 sNDA priority review designation

The US Food and Drug Administration (FDA) has accepted for filing Axsome Therapeutics’ supplemental New Drug Application (NDA ...

Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026NEW YORK, (GLOBE NEWSWIRE) -- ...
Business Insider

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in GEMINI Phase 3 Trial in Major Depressive Disorder

AXS-05 demonstrated a statistically significant mean reduction from baseline in the MADRS total score of 7.3 points for AXS-05 compared to 4.9 points for placebo at Week 1 (p=0.007), with statistical ...
Nasdaq

Axsome AXS-05 results in ADA ‘positive,’ drug looks ‘approvable,’ says Truist

After Axsome Therapeutics (AXSM) reported topline data from the studies of AXS-05 in Alzheimer’s disease agitation, Truist analyst Joon Lee noted that while the ADVANCE-2 study missed statistical ...
WCBD

Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission

NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today ...
Seeking Alpha

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ACCORD Phase 3 Trial in Alzheimer’s Disease Agitation

AXS-05 met the primary endpoint by substantially and statistically significantly delaying the time to relapse of Alzheimer’s disease agitation as compared to placebo (hazard ratio for time to relapse ...
Seeking Alpha

Axsome Therapeutics Remains A Buy Despite AXS-05's Mixed Results

Axsome Therapeutics shows strong revenue growth from Auvelity and Sunosi, with promising late-stage pipeline drugs for migraine, fibromyalgia, and narcolepsy. Late-stage pipeline milestones include ...
CNN

Axsome Therapeutics Completes Patient Randomization in the STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression

NEW YORK, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system ...
Nasdaq

Axsome's AXS-05 Gets Breakthrough Therapy Tag for AD Agitation

Axsome Therapeutics, Inc. AXSM announced that the FDA has granted a Breakthrough Therapy designation to AXS-05 for the treatment of agitation associated with Alzheimer's disease (AD). The status was ...