United States — Food and Drug Administration & Paragon Therapeutics

United States — Food and Drug Administration: The United States — Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee is convening a meeting to review Paragon Therapeutics' Biologics License Application for Deramiocel, which is a critical step in the regulatory approval process for the drug.

Paragon Therapeutics: Paragon Therapeutics announced that the Cellular, Tissue, and Gene Therapies Advisory Committee of the United States — Food and Drug Administration will convene a meeting to discuss its Biologics License Application for Deramiocel, a cell therapy for Duchenne muscular dystrophy. This is a significant step towards potential market approval for their lead product candidate.

Paragon Therapeutics: Paragon Therapeutics is facing a class action lawsuit for allegedly providing misleading statements regarding its lead cell therapy candidate drug, deramiocel, which led to a significant stock price decline after the United States — Food and Drug Administration denied its Biologics License Application.