Abeona Therapeutics closed a $155 million sale of its Rare Pediatric Disease PRV, enhancing financial stability ahead of ZEVASKYN launch.
Quiver AI Summary
Abeona Therapeutics Inc. announced the successful sale of its Rare Pediatric Disease Priority Review Voucher for $155 million, closing the transaction on June 27, 2025. This sale significantly boosts the company’s financial position, with unaudited cash and equivalents reaching approximately $225 million as of June 30, 2025, providing over two years of operating capital without the need for additional funding. Abeona expects to begin treating patients with its gene therapy product, ZEVASKYN, in the third quarter of 2025, projecting profitability by early 2026. The FDA awarded the PRV to Abeona in April 2025 following the approval of ZEVASKYN, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa.
Potential Positives
- Abeona Therapeutics closed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million, providing a significant financial boost.
- The sale proceeds, along with existing cash reserves, ensure over two years of operating capital for the company, supporting sustained growth without immediate need for further capital infusion.
- The anticipated first patient treatment with ZEVASKYN is set for Q3 2025, with profitability projected for early 2026, indicating a positive outlook for the company’s commercialization efforts.
- Abeona is positioned with the only U.S. approved autologous cell-based gene therapy for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa, enhancing its market differentiation and potential market share.
Potential Negatives
- The reliance on a Priority Review Voucher (PRV) sale for substantial funding may indicate the company lacks other sustainable revenue sources.
- Forward-looking statements suggest significant uncertainty related to the commercialization of ZEVASKYN, including potential failure to meet market expectations.
- The company has outlined various risks and uncertainties, indicating potential challenges that could affect performance and shareholder confidence.
FAQ
What is the recent milestone achieved by Abeona Therapeutics?
Abeona Therapeutics successfully closed the sale of its Rare Pediatric Disease Priority Review Voucher for $155 million.
What are the financial implications of the PRV sale for Abeona?
The PRV sale provides Abeona with approximately $225 million in cash equivalents, ensuring over two years of operating capital.
When is the anticipated first treatment of ZEVASKYN?
The first patient treatment with ZEVASKYN is anticipated in Q3 2025.
What is ZEVASKYN and its significance?
ZEVASKYN is the first approved autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa.
Where is Abeona's manufacturing facility located?
Abeona's manufacturing facility is located in Cleveland, Ohio, and supports the commercial production of ZEVASKYN.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ABEO Insider Trading Activity
$ABEO insiders have traded $ABEO stock on the open market 8 times in the past 6 months. Of those trades, 0 have been purchases and 8 have been sales.
Here’s a breakdown of recent trading of $ABEO stock by insiders over the last 6 months:
- VISHWAS SESHADRI (Chief Executive Officer) has made 0 purchases and 2 sales selling 75,676 shares for an estimated $462,069.
- JOSEPH WALTER VAZZANO (Chief Financial Officer) sold 17,795 shares for an estimated $120,294
- MARK ALVINO has made 0 purchases and 4 sales selling 18,000 shares for an estimated $100,120.
- BRENDAN M. O'MALLEY (SVP, General Counsel) sold 10,470 shares for an estimated $70,777
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ABEO Hedge Fund Activity
We have seen 40 institutional investors add shares of $ABEO stock to their portfolio, and 20 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- MILLENNIUM MANAGEMENT LLC removed 1,307,203 shares (-61.7%) from their portfolio in Q1 2025, for an estimated $6,222,286
- ADAGE CAPITAL PARTNERS GP, L.L.C. removed 1,210,732 shares (-31.0%) from their portfolio in Q1 2025, for an estimated $5,763,084
- KENNEDY CAPITAL MANAGEMENT LLC added 621,763 shares (+inf%) to their portfolio in Q1 2025, for an estimated $2,959,591
- WALLEYE CAPITAL LLC removed 402,944 shares (-68.7%) from their portfolio in Q1 2025, for an estimated $1,918,013
- MARSHALL WACE, LLP added 281,072 shares (+547.6%) to their portfolio in Q1 2025, for an estimated $1,337,902
- JPMORGAN CHASE & CO added 233,745 shares (+1669607.1%) to their portfolio in Q1 2025, for an estimated $1,112,626
- WESTERN STANDARD LLC added 196,781 shares (+9.4%) to their portfolio in Q1 2025, for an estimated $936,677
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$ABEO Analyst Ratings
Wall Street analysts have issued reports on $ABEO in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Alliance Global Partners issued a "Buy" rating on 05/15/2025
- Oppenheimer issued a "Outperform" rating on 03/05/2025
To track analyst ratings and price targets for $ABEO, check out Quiver Quantitative's $ABEO forecast page.
$ABEO Price Targets
Multiple analysts have issued price targets for $ABEO recently. We have seen 2 analysts offer price targets for $ABEO in the last 6 months, with a median target of $18.0.
Here are some recent targets:
- Stephen Willey from Stifel Nicolaus set a target price of $20.0 on 05/16/2025
- An analyst from Oppenheimer set a target price of $16.0 on 03/05/2025
Full Release
CLEVELAND, July 02, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million on June 27, 2025.
Including net proceeds from the sale of the PRV, the Company reported that unaudited cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025 were approximately $225 million.
“We have reached another key milestone: the successful sale of our PRV has closed,” said Joe Vazzano, Chief Financial Officer of Abeona. “The PRV proceeds, combined with our existing cash, provides Abeona with robust financial flexibility, ensuring over two years of operating capital for sustained growth without the need for further capital infusion and prior to accounting for ZEVASKYN sales. We anticipate the first ZEVASKYN patient treatment in Q3 2025, with profitability projected for early 2026.”
Abeona was awarded the PRV by the U.S. Food and Drug Administration (FDA) in April 2025 in connection with the FDA’s approval of ZEVASKYN™ (prademagene zamikeracel), the first and only U.S. approved autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa.
About Abeona Therapeutics
Abeona 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
.
ZEVASKYN TM , Abeona Assist TM , Abeona Therapeutics ® , and their related logos are trademarks of Abeona Therapeutics Inc.
Forward-Looking Statements
This 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 commercialize ZEVASKYN; the therapeutic potential of ZEVASKYN, whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company’s expectations, continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with and inspections from the FDA or other regulatory agencies, including those relating to preclinical programs; our ability to obtain necessary regulatory approvals; the impact of any changes in the financial markets or 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 securities laws.