Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that the U.S. Food and Drug Administration (FDA) has agreed to review the resubmitted Biologics License Application (BLA) for prademagene zamikeracel (pz-cel).
Prominent metrics and vital knowledge
- Prademagene zamikeracel (pz-cel) is an experimental autologous cell therapy being explored as a potential treatment for recessive dystrophic epidermolysis bullosa (RDEB).
- The resubmission of the BLA is backed by clinical efficacy and safety data obtained from a single administration of pz-cel, derived from the pivotal Phase 3 VIITAL™ study and a Phase 1/2a study with follow-up extending up to 8 years.
- A target action date of April 29, 2025, has been established by the FDA in accordance with the Prescription Drug User Fee Act (PDUFA).
- Vish Seshadri, Chief Executive Officer of Abeona, commented, “The FDA acceptance of our BLA resubmission moves us one step closer to providing pz-cel as a differentiated treatment option to address the persistent unmet needs of people with RDEB in the U.S.”.
- The FDA has previously accepted the Company’s Biologics License Application (BLA) for pz-cel under Priority Review for patients suffering from RDEB. If pz-cel resubmission receives approval, Abeona may qualify for a Priority Review Voucher (PRV).
- The previous trading day saw Abeona Therapeutics Inc. (ABEO) shares trading between $6.31 and $6.52, besides a volume of 450.50 thousand shares. The stock closed Monday’s regular trading session at $6.43, indicating 0.47 percent advance.
