Argent Biopharma LtdASX: RGT

FDA-CVM Establish INAD File for CannEpil Veterinary Program

· Issued by Argent Biopharma Ltd

Filed with ASX · · 3 pages · English

Summary by 6ix AI

Argent Biopharma Ltd has announced that the U.S. FDA Center for Veterinary Medicine has established an Investigational New Animal Drug file for CannEpil, marking a significant regulatory milestone for its veterinary development program. The initial focus of this program is on managing cancer-related pain in companion animals, starting with canine oncology. The establishment of the INAD file allows for formal interactions with the FDA regarding product development and regulatory submissions. Roby Zomer, Chairman, emphasized that this milestone reflects progress in their licensing strategy and the potential for additional value from CannEpil.

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