Abeona Therapeutics INC 8-K filings

Abeona Therapeutics received a Complete Response Letter from the FDA for its pz-cel Biologics License Application, requiring additional Chemistry, Manufacturing, and Controls information, but not raising concerns about clinical efficacy or safety.

Abeona Therapeutics reported its full year 2023 financial results and announced the completion of FDA inspections for its pz-cel manufacturing facility and clinical trial sites.