CRL cuts Abeona market cap in half

US biopharma Abeona Therapeutics (Nasdaq: ABEO) was trading nearly 50% lower in Tuesday morning’s activity after announcing a regulatory update for prademagene zamikeracel (pz-cel).

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the company’s Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB).

"We anticipate completing the BLA resubmission in the third quarter of 2024"The CRL follows the completion of Abeona’s late cycle review meeting with the FDA last month. At the meeting, and in a subsequent information request, the FDA noted that additional information needed to satisfy Chemistry Manufacturing and Controls (CMC) requirements must be satisfactorily resolved before the application can be approved.