U.s. fda approves zevaskyn™ (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (rdeb)

- 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 - cleveland, april 29, 2025 (globe newswire) -- abeona therapeutics inc. (nasdaq: abeo) today announced the u.s. food and drug administration (fda) has approved zevaskyn™ (pronounced as ‘zee-vah-skin') (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (rdeb), a serious and debilitating genetic skin disease.
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