Abeona Therapeutics agrees to sell priority review voucher for $155 million

The deal

Abeona Therapeutics Inc. (Nasdaq: ABEO) said on May 12, 2025 that it had signed a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher, or PRV, for gross proceeds of $155 million at closing. The company, based in Cleveland, was awarded the voucher after the U.S. Food and Drug Administration approved ZEVASKYN (prademagene zamikeracel) on April 28, 2025.

The release does not name the buyer and does not give any price terms beyond the gross proceeds. The sale is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino Antitrust Improvements Act. Until it closes, the $155 million is a contract term rather than cash in hand.

Advisors

Stifel was lead financial advisor to Abeona on the transaction, and Jefferies also served as a financial advisor. The release does not name the buyer's advisors, Abeona's legal counsel or any fees. The release names no underwriter or placement agent.

What the company says about its cash

Joe Vazzano, Abeona's Chief Financial Officer, said: "With proceeds from this PRV sale, we have sufficient cash for more than two years of operating expenses without the need for capital infusion and not accounting for ZEVASKYN sales." He added that, with ZEVASKYN becoming available to treat patients beginning in the third quarter of 2025, the company anticipates becoming profitable in early 2026. Both statements are management's expectations. The release gives no cash balance, no operating expense figure and no sales data, so the claim of more than two years of cash cannot be checked against numbers in the release itself.

The product behind the voucher

ZEVASKYN is, in the company's words, the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa, or RDEB. The company's annual report for 2024, filed March 20, 2025, describes RDEB as a genetic skin disorder in which a defect in the COL7A1 gene leaves patients unable to make Type VII collagen. Patients have fragile skin that forms open and blistering wounds, and long-term patients can suffer from anemia and are at high risk of aggressive squamous cell carcinomas, infections and premature death. The report says the most severe patients are approximately 20 times more likely to die by 30 years of age than the general population.

The path to approval was not smooth. Abeona announced positive top-line data from its VIITAL study in November 2022, saying it met both co-primary endpoints, with statistically significant improvements in wound healing and pain reduction in large chronic wounds. It submitted a Biologics License Application in September 2023, and the FDA accepted it with priority review and set a target action date of May 25, 2024. In April 2024 the FDA issued a Complete Response Letter. The letter said certain additional information on chemistry, manufacturing and controls had to be resolved before approval. It did not identify deficiencies in clinical efficacy or safety data, and the FDA did not ask for new trials. Abeona completed a Type A meeting with the FDA in August 2024 and resubmitted in October 2024. The FDA accepted the resubmission in November 2024 with a target action date of April 29, 2025, and approved the therapy on April 28, 2025, before that date.

Pipeline and manufacturing

Apart from ZEVASKYN, the company's development portfolio features adeno-associated virus gene therapies for eye diseases, built on capsids licensed from the University of North Carolina at Chapel Hill and developed in-house. These are still being evaluated. ZEVASKYN is made at the company's Cleveland, Ohio manufacturing facility.

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