Abeona Nets $155M in Voucher Sale After FDA Approval

Abeona Therapeutics has secured a $155 million deal from the sale of a Priority Review Voucher (PRV), just two weeks after receiving U.S. Food and Drug Administration (FDA) approval for its first commercial product. The company did not disclose the name of the buyer.
The PRV was awarded following the FDA’s approval of Zevaskyn, a gene therapy developed to treat recessive dystrophic epidermolysis bullosa (RDEB), a rare and serious skin disorder. Zevaskyn is an autologous, cell-based therapy that uses a patient’s own genetically modified skin cells to produce functional Type VII collagen. It is applied as a sheet to wound areas and is designed to aid in healing chronic wounds and alleviating pain associated with RDEB.

Priority Review Vouchers are issued by the FDA as an incentive to encourage the development of treatments for rare or neglected diseases. These vouchers allow the holder to expedite the review process of another drug application. For companies developing competitive or time-sensitive therapies, the shortened review period can be of considerable value. Recent PRV sales in the industry have ranged between $150 million and $158 million, placing Abeona’s transaction within the typical market range.
In a press release issued Monday, Abeona stated that the proceeds from the sale position the company with enough operating capital for over two years without requiring additional funding or factoring in revenue from Zevaskyn. Chief Financial Officer Joe Vazzano noted that the company expects to reach profitability in early 2026.
Zevaskyn is scheduled for commercial launch in the third quarter of 2025. Abeona has indicated a phased rollout strategy, with an initial projection of 10 to 15 patients treated in the first year. This estimate reflects a deliberate approach to adoption, which the company anticipates will accelerate over time.
Abeona CEO Vishwas Seshadri discussed the rationale behind the timing of the PRV sale. He cited continued demand for such vouchers, with the last four PRV transactions in the industry all closing at $150 million or more. Seshadri emphasized the company’s intent to complete the transaction quickly in light of regulatory uncertainties surrounding the PRV program.

The sale of the PRV also comes at a time when Abeona faces broader market challenges. The company has experienced pressure from a depressed stock price, limiting its ability to raise capital through equity. The $155 million infusion from the voucher sale provides an alternative financial strategy to support operations and the commercial development of its approved product.
Zevaskyn will enter a therapeutic space that includes other treatment options for epidermolysis bullosa, such as a weekly topical gel from Krystal Biotech. Unlike its competitor, Zevaskyn is a one-time treatment, which differentiates its method of delivery and application.
Following the announcement of the PRV sale, Abeona’s stock rose approximately 10%, reaching about $6 per share in early trading. The transaction underscores a shift in Abeona’s operational strategy as it transitions from development-stage biotech to a commercial-stage company.