Ensysce Biosciences Receives Positive FDA Feedback on PF614 Manufacturing Approach
Ensysce BiosciencesEnsysce Biosciences(US:ENSC) Accessnewswire·2025-11-20 13:00

Core Points - The FDA has provided Written Responses to Ensysce Biosciences regarding its request for guidance on the manufacturing approach for PF614 [1] - Ensysce is focused on developing next-generation pain and central nervous system therapeutics aimed at reducing abuse and overdose risks [1] Company Summary - Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company [1] - The company is listed on NASDAQ under the ticker ENSC [1] - The request to the FDA was aimed at understanding the appropriateness of regulatory starting materials (RSMs) and specifications for the PF614 drug substance [1]