FDA OKs Abeona ZEVASKYN Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa

  ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure -

- Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile -

- ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025 -

- Abeona Assist™ patient services program offers personalized support for eligible patients and families throughout their treatment journey with ZEVASKYN -

- Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA -

- Abeona Therapeutics® to host conference call today, Tuesday, April 29, 2025, at 8:00 a.m. ET -

Abeona Therapeutics will host a conference call and webcast with accompanying slides and patient videos today, Tuesday, April 29, 2025, at 8:00 a.m. ET. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 320280 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed at https://investors.abeonatherapeutics.com/events. The archived webcast replay will be available for 30 days following the call.

https://investors.abeonatherapeutics.com/press-releases/detail/303/u-s-fda-approves-zevaskyn-prademagene-zamikeracel