Adial gets FDA nod for AD04 in vitro bridging strategy; Phase 3 path clear

ADIAL PHARMACEUTICALS, INC.

FDA agreed with proposed 505(b)(2) bridging strategy for AD04, leveraging AD04-103 study and in vitro data.
Adial to manufacture clinical supplies for Phase 3 program in 2025 following FDA confirmation.
Submission was made on Nov 19, 2024; FDA feedback received Feb 25, 2025.
AD04 is a genetically targeted therapy for Alcohol Use Disorder; ONWARD Phase 3 trial completed.
CEO Cary Claiborne says milestone brings AD04 closer to regulatory approval.

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