Spring has been bountiful at Cleveland's Abeona Therapeutics.
Two weeks after the company picked up FDA approval for its first commercial product, Abeona has inked a deal to sell the FDA priority review voucher it gained along with the approval.
Abeona agreed to sell the PRV for $155 million, the company said in a Monday press release. The company didn't disclose the name of the buyer.
PRVs can be used to speed up the review process for drug applications at the FDA. For a highly anticipated new therapy or a candidate in a competitive drug class, drugmakers often find it worthwhile to spend hefty chunks of cash to get in the fast lane at the FDA.
Abeona, for its part, didn't spell out how it plans to use the proceeds from the sale. The deal comes two weeks after the company picked up FDA approval for Zevaskyn to treat recessive dystrophic epidermolysis bullosa (RDEB), so it's likely some portion of the cash will be used to fuel the commercial debut.
With the PRV sale, the company has "sufficient cash for more than two years of operating expenses without the need for capital infusion and not accounting for Zevaskyn sales," CFO Joe Vazzano said in a statement.
The company anticipates launching its drug in the third quarter of 2025 and believes it's on track to become profitable early next year, Vazzano added.
Zevaskyn is an autologous cell-based gene therapy that utilizes a patient's skin cells that have been reengineered to produce functional Type VII collagen. Patients with RDEB suffer from wounds that cover a large portion of their body surface. The drug is applied as a "sheet" over wound areas and has shown an ability to heal large chronic RDEB wounds and relieve pain.
The value of the Abeona PRV sale agreement comes roughly in line with other recent PRV transactions in the industry. In February, Zevra inked a deal to sell a PRV for $150 million to an unnamed buyer. In November, PTC Therapeutics sold a voucher for $150 million, again without disclosing the buyer's identity.