PITTSBURGH, Aug. 21, 2023 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (NASDAQ: KRYS) (the “Company”), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.
The Company was awarded the PRV following the U.S. Food and Drug Administration (FDA) accelerated approval of VYJUVEKTM (beremagene geperpavec-svdt) for the treatment of recessive or dominant dystrophic epidermolysis bullosa (DEB) for patients 6 months of age and older.
Under the Rare Pediatric Disease Priority Review Voucher Program, the FDA awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, or alternatively, sold or transferred.
About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEKTM is the Company’s first commercial product, the first-ever redosable gene therapy, and the only medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and Twitter.
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