Abeona Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits
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Item 1.01 Entry into a Material Definitive Agreement
On May 9, 2025, Abeona Therapeutics Inc. (the “Company”) entered into an asset purchase agreement (the “PRV Asset Purchase Agreement”), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher (“PRV”) to the buyer. The Company was awarded the voucher by the U.S. Food and Drug Administration (“FDA”) on April 28, 2025, upon approval of the Company’s biologics license application for ZEVASKYN™ (prademagene zamikeracel). Pursuant to the PRV Asset Purchase Agreement, the buyer agreed to pay the Company $155 million, payable in cash, upon the closing of the sale.
The PRV Asset Purchase Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
The foregoing description of the PRV Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Asset Purchase Agreement, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025.
Item 8.01 Other Events.
On May 12, 2025, Abeona Therapeutics Inc. issued a press release entitled “Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release dated May 12, 2025, entitled “Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million.” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Abeona Therapeutics Inc. | ||
| (Registrant) | ||
| By: | /s/ Joseph Vazzano | |
| Name: | Joseph Vazzano | |
| Title: | Chief Financial Officer | |
| Date: May 12, 2025 | ||