On May 15, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the first quarter of 2024 and provided a business update. The company is planning to resubmit the Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB) in the second half of 2024 following the receipt of a Complete Response Letter (CRL) in April 2024. The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data but did request additional CMC information. The company believes that all of the CMC deficiencies noted in the CRL will be addressed in late Q2 or early Q3 2024. A Type A meeting with the FDA will be conducted in Q3 2024 to ensure the company has addressed the outstanding issues raised in the CRL. Abeona recently closed a $75 million financing that extends the company's cash runway into 2026, which does not take into account any potential revenue from sales of pz-cel or the sale of a PRV, if awarded by the FDA.
