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Abeona Therapeutics Enters into Agreement to Sell Priority Review Voucher for $155 Million CLEVELAND

Key Takeaway: Abeona Therapeutics Inc. has announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $155 million. The proceeds will provide the company with enough cash to support operations for over two years. Following FDA approval for ZEVASKYN, the company expects the treatment to be available to patients by the third quarter of 2025, with plans for profitability in early 2026. The transaction is subject to standard closing conditions, including a review under the Hart-Scott Rodino Antitrust Improvements Act.

Market Sentiment Analysis

POSITIVE FACTORS

  • Abeona Therapeutics is selling its Priority Review Voucher for $155 million, providing a strong financial boost.
  • The company projects sufficient cash to cover over two years of operating expenses following the PRV sale.
  • ZEVASKYN is anticipated to become available for patient treatment, with profitability expected by early 2026.

CONCERNS & RISKS

  • The sale is subject to customary closing conditions, including antitrust review, which may pose delays or complications.
  • The actual outcomes of ZEVASKYN's commercial sales and revenue generation remain uncertain.

Full Press Release Details

Therapeutics Enters into Agreement to Sell Priority Review Voucher for $155 Million
May 12, 2025 - Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has entered into a definitive asset purchase agreement
to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million upon the closing of the transaction.
Abeona was awarded the PRV following the U.S. Food and Drug Administration (FDA) approval of ZEVASKYN (prademagene zamikeracel)
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," said Joe Vazzano, Chief Financial Officer of Abeona. "Furthermore, with ZEVASKYN
becoming available to treat patients beginning third quarter of 2025, we anticipate becoming profitable in early 2026."
transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino
(HSR) Antitrust Improvements Act.
was lead financial advisor to Abeona on the transaction. Jefferies also served as financial advisor on the transaction.
Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona's
ZEVASKYN (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults
and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company's fully integrated cell and gene therapy
cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company's
development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need.
Abeona's novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases.
For more information, visit www.abeonatherapeutics.com.
Abeona Assist , Abeona Therapeutics , and their related logos are trademarks of Abeona Therapeutics Inc.
press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted
to identify forward-looking statements by such terminology as "may,"
"will," "believe," "anticipate,"
"expect," "intend," "potential,"
and similar words and expressions (as well as other words or expressions referencing future events,
conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including
but not limited to, our ability to successfully generate commercial sales of ZEVASKYN and generate future revenue; the successful closing
of our sale transaction for the Priority Review Voucher; continued interest in our rare disease portfolio; our ability to enroll patients
in clinical trials; the outcome of future meetings with the FDA or other regulatory agencies, including those relating to preclinical
programs; the ability to achieve or obtain necessary regulatory approvals; the impact of any changes in the financial markets and global
economic conditions; risks associated with data analysis and reporting; and other risks disclosed in the Company's
most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company
undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after
the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal
Investor Relations and Corporate Communications

Frequently Asked Questions

What is the value of Abeona's Priority Review Voucher?

Abeona's Priority Review Voucher is being sold for $155 million.

When will ZEVASKYN become available for patients?

ZEVASKYN is expected to be available for patients in the third quarter of 2025.

What condition does ZEVASKYN treat?

ZEVASKYN treats recessive dystrophic epidermolysis bullosa (RDEB) in patients.

Who advised Abeona on the PRV sale transaction?

Jefferies acted as the financial advisor for Abeona on the transaction.

How long will the PRV proceeds fund operations?

The proceeds from the PRV sale will cover over two years of operating expenses.

Last updated: May 12, 2025