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Abeona Therapeutics® Reports Full Year 2024 Financial Results, Provides Pz-cel Regulatory Update and Commercial Launch Plans
FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025 Launch preparations on track toward goal to treat first patient in 3Q 2025 CLEVELAND, March 20, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2024, and announced progress in the ongoing review with the U.S. Food and Drug Administration (FDA) regarding prademagene zamikeracel (pz-cel) and plans for the U.S. commercial launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), if approved. The Company will host a conference call and webcast today at 8:30 a.m. ET. “The RDEB community continues to highlight the unmet medical need for new therapies that could provide long-lasting healing and pain reduction, even in tough large, chronic RDEB wounds,” said Vish Seshadri, Chief Executive Officer of Abeona. “With a PDUFA date of April 29, 2025, the BLA review by the FDA is on track as discussions are underway regarding post-marketing requirements and commitments as well as the draft label.” Fourth Quarter and Recent Progress Pz-cel for RDEB Abeona continues to work with the FDA to finalize the review of its Biologics License Application (BLA) for pz-cel as a potential new treatment for patients with RDEB. In November 2024, the FDA accepted the BLA resubmission for review and set a PDUFA target action date of April 29, 2025. On March 14, 2025, Abeona received draft United States Prescribing Information (USPI) from the FDA to initiate discussion on the label for pz-cel. Discussions are also ongoing with the FDA on post-approval marketing requirements and commitments for pz-cel. If approved, the Company anticipates the first patient treatment with pz-cel in the third quarter of 2025. Abeona may be eligible for a Priority Review Voucher (PRV) should pz-cel be approved.In anticipation of potential FDA approval of pz-cel, Abeona continues its commercialization efforts, including progress toward onboarding five geographically dispersed, well-recognized epidermolysis bullosa treatment centers in the U.S. as pz-cel qualified treatment centers (QTCs), engaging payers to ensure patient access, and educating key stakeholders.In preparation for potential pz-cel launch, Abeona has hired and trained personnel to...