Axsome to Submit NDA for AXS-05 in Alzheimer Agitation …
23 hours ago · Axsome Therapeutics Announces Successful Completion and Results of Phase 3 Clinical Program of AXS-05 in Alzheimer’s Disease Agitation. News release. Axsome Therapeutics. December 30, 2024. ... Axsome Therapeutics announces AXS-05 achieves primary end point in the ACCORD phase 3 trial in Alzheimer’s disease agitation. News release. November ...
Axsome to send Alzheimer’s disease drug to FDA, despite mixed …
Dec 30, 2024 · Axsome Therapeutics is moving ahead with plans to submit its Alzheimer’s disease treatment for Food and Drug Administration approval despite mixed results from two new clinical trial readouts ...
Axsome to seek approval of AXS-05 to treat agitation in Alzheimer's disease
3 days ago · The results from ACCORD-2 are largely consistent with an earlier study called ACCORD (NCT04797715) that also showed AXS-05 was better than a placebo at preventing agitation relapse in Alzheimer’s patients. “Agitation is one of the most troubling and consequential aspects of Alzheimer’s disease, poses significant challenges to both the patient and their family, and represents a high unmet ...
Axsome to seek approval for Alzheimer's-related agitation drug …
Dec 30 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Monday it would seek marketing approval next year for its oral drug to treat agitation in patients with Alzheimer's disease ...
Axsome Therapeutics Announces Successful Completion and
Dec 30, 2024 · Four completed pivotal, Phase 3, placebo-controlled trials support efficacy and safety of AXS-05 in Alzheimer’s disease agitation
Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite …
Dec 30, 2024 · Agitation caused by Alzheimer’s disease currently has one FDA-approved therapy, but that drug brings serious safety risks. An Axsome Therapeutics drug has mixed results from its latest slate of...
Axsome Posts Mixed Phase III Data in Alzheimer’s Agitation
4 days ago · Axsome Therapeutics said Monday it plans to seek FDA approval in Alzheimer’s disease agitation despite seeing mixed results in late-phase studies. The biotech reported data from two trials of AXS-05, a combination of dextromethorphan and bupropion that is already used to treat major depressive disorder.
Axsome Reveals Data From Alzheimer's Studies, Analyst Sees
6 days ago · On Monday, Axsome Therapeutics, Inc. AXSM released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in Alzheimer's disease agitation.
Axsome Therapeutics Announces Successful Completion and …
Dec 30, 2024 · Axsome Therapeutics, Inc. ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse)
Axsome Therapeutics Reports Positive Results from ACCORD-2
Dec 30, 2024 · ACCORD-2 Phase 3 trial achieved primary endpoint with AXS-05 significantly delaying the time to relapse of agitation in Alzheimer's disease compared to placebo (p=0.001). Four completed pivotal...
- Some results have been removed