Svo002 looking good21 Jun 2025 12:48
Solvonis Therapeutics plc (LON: SVNS), ("Solvonis" or the "Company") an innovative biotechnology company co-developing therapeutics for mental health disorders, is pleased to announce that Awakn Life Sciences Corp. ("Awakn"), the company Solvonis plans to acquire, has reached a significant regulatory milestone. Awakn announced a positive outcome from a Pre-Investigational New Drug ("Pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") regarding AWKN-002, a proprietary oral thin film ("OTF") formulation of esketamine, designed for sublingual and buccal administration in combination with structured alcohol education. This drug candidate is being developed for the treatment of moderate to severe alcohol use disorder ("AUD") with a focus on U.S market.