Abeona Therapeutics庐 Closes Sale of Rare Pediatric Disease Priority Review Voucher for $155 Million
Abeona Therapeutics (Nasdaq: ABEO) has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $155 million on June 27, 2025. The company's cash position, including PRV proceeds, reached approximately $225 million as of June 30, 2025.
The PRV was awarded by the FDA in April 2025 following the approval of 窜贰痴础厂碍驰狈鈩�, the first FDA-approved autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa. The company expects to begin patient treatments with ZEVASKYN in Q3 2025 and projects profitability by early 2026.
Abeona Therapeutics (Nasdaq: ABEO) ha completato la vendita del suo Voucher per la Revisione Prioritaria per Malattie Pediatriche Rare (PRV) per 155 milioni di dollari il 27 giugno 2025. La posizione di cassa dell'azienda, inclusi i proventi del PRV, ha raggiunto circa 225 milioni di dollari al 30 giugno 2025.
Il PRV 猫 stato assegnato dalla FDA nell'aprile 2025 a seguito dell'approvazione di 窜贰痴础厂碍驰狈鈩�, la prima terapia genica autologa a base cellulare approvata dalla FDA per il trattamento delle ferite nei pazienti con epidermolisi bollosa distrofica recessiva. L'azienda prevede di iniziare i trattamenti ai pazienti con ZEVASKYN nel terzo trimestre del 2025 e stima di raggiungere la redditivit脿 all'inizio del 2026.
Abeona Therapeutics (Nasdaq: ABEO) ha completado la venta de su Vale de Revisi贸n Prioritaria para Enfermedades Pedi谩tricas Raras (PRV) por 155 millones de d贸lares el 27 de junio de 2025. La posici贸n de efectivo de la compa帽铆a, incluyendo los ingresos del PRV, alcanz贸 aproximadamente 225 millones de d贸lares al 30 de junio de 2025.
El PRV fue otorgado por la FDA en abril de 2025 tras la aprobaci贸n de 窜贰痴础厂碍驰狈鈩�, la primera terapia g茅nica basada en c茅lulas aut贸logas aprobada por la FDA para el tratamiento de heridas en pacientes con epiderm贸lisis bullosa distr贸fica recesiva. La compa帽铆a espera comenzar los tratamientos a pacientes con ZEVASKYN en el tercer trimestre de 2025 y proyecta rentabilidad a principios de 2026.
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鞚� PRV電� 2025雲� 4鞗� FDA臧� 窜贰痴础厂碍驰狈鈩�鞚� 鞀轨澑頃� 頉� 靾橃棳霅橃棃鞙茧┌, 鞚措姅 鞐挫劚 鞙犾爠靹� 響滍敿氚曤Μ歃� 頇橃瀽鞚� 靸侅矘 旃橂毳� 鞙勴暅 FDA 鞀轨澑 斓滌磮鞚� 鞛愱皜 靹疙彫 旮半皹 鞙犾爠鞛� 旃橂鞝滌瀰雼堧嫟. 須岇偓電� 2025雲� 3攵勱赴鞐� ZEVASKYN 頇橃瀽 旃橂毳� 鞁滌瀾頃� 鞓堨爼鞚措┌, 2026雲� 齑堦箤歆� 靾橃澋靹膘潉 雼劚頃� 瓴冹溂搿� 鞓堨儊頃╇媹雼�.
Abeona Therapeutics (Nasdaq : ABEO) a finalis茅 la vente de son bon de r茅vision prioritaire pour maladies p茅diatriques rares (PRV) pour 155 millions de dollars le 27 juin 2025. La tr茅sorerie de l'entreprise, incluant les recettes du PRV, s'茅levait 脿 environ 225 millions de dollars au 30 juin 2025.
Le PRV a 茅t茅 attribu茅 par la FDA en avril 2025 suite 脿 l'approbation de 窜贰痴础厂碍驰狈鈩�, la premi猫re th茅rapie g茅nique autologue 脿 base cellulaire approuv茅e par la FDA pour le traitement des plaies chez les patients atteints d'茅pidermolyse bulleuse dystrophique r茅cessive. L'entreprise pr茅voit de commencer les traitements des patients avec ZEVASKYN au troisi猫me trimestre 2025 et projette d'atteindre la rentabilit茅 d茅but 2026.
Abeona Therapeutics (Nasdaq: ABEO) hat am 27. Juni 2025 den Verkauf seines Priority Review Voucher (PRV) f眉r seltene p盲diatrische Krankheiten f眉r 155 Millionen US-Dollar abgeschlossen. Die Barreserven des Unternehmens, einschlie脽lich der Erl枚se aus dem PRV, beliefen sich zum 30. Juni 2025 auf etwa 225 Millionen US-Dollar.
Der PRV wurde von der FDA im April 2025 nach der Zulassung von 窜贰痴础厂碍驰狈鈩� vergeben, der ersten von der FDA zugelassenen autologen zellbasierten Gentherapie zur Behandlung von Wunden bei Patienten mit rezessiver dystropher epidermolysis bullosa. Das Unternehmen plant, im dritten Quartal 2025 mit der Behandlung von Patienten mit ZEVASKYN zu beginnen und rechnet mit der Erzielung von Gewinnen Anfang 2026.
- Secured $155 million from PRV sale, strengthening cash position to $225 million
- Cash runway extended to over two years without need for additional capital
- First ZEVASKYN patient treatment expected in Q3 2025
- Profitability projected for early 2026
- None.
Cash resources totaled approximately
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
Including net proceeds from the sale of the PRV, the Company reported that unaudited cash, cash equivalents, restricted cash and short-term investments聽as of June 30, 2025 were approximately
鈥淲e have reached another key milestone: the successful sale of our PRV has closed,鈥� said Joe Vazzano, Chief Financial Officer of Abeona. 鈥淭he 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.鈥�
Abeona was awarded the PRV by the U.S. Food and Drug Administration (FDA) in April 2025 in connection with the FDA鈥檚 approval of 窜贰痴础厂碍驰狈鈩� (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鈥檚 窜贰痴础厂碍驰狈鈩� (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鈥檚 fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company鈥檚 development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona鈥檚 novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. For more information, visit .
ZEVASKYNTM, Abeona AssistTM, Abeona Therapeutics庐, 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 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渂elieve,鈥� 鈥渁nticipate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥減otential,鈥� 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鈥檚 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鈥檚 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.
Investor and Media Contact: Greg Gin VP, Investor Relations and Corporate Communications Abeona Therapeutics [email protected]
FAQ
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