Axsome Therapeutics gets FDA support to submit sNDA for its Alzheimer’s disease agitation treatment
Axsome Therapeutics (NASDAQ:AXSM) said on Monday that in the FDA meeting minutes, the agency has supported a supplemental NDA ...
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission
Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation. Axsome ...
Axsome Therapeutics expects to submit sNDA for AXS-05 in Q3
Axsome Therapeutics (AXSM) has received formal pre-New Drug Application meeting minutes from the U.S. Food and Drug Administration supporting a ...
Yahoo Finance14d
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission
“We are pleased with the pre-NDA meeting feedback we received from the FDA, which confirmed the studies and data to be presented in our planned sNDA submission of AXS-05 for the treatment of ...
Financial Post14d
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer's Disease Agitation Supporting NDA Submission
Acceptance of the final sNDA will be subject to the FDA’s review of the complete filing. AXS-05 was granted Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in June ...