Categories: News

Krystal Biotech Announces Sale of Priority Review Voucher for $100 Million

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.

CONTACT:
Investors and Media:                                                                
Meg Dodge                                                      
Krystal Biotech                                                    
mdodge@krystalbio.com

Staff

Recent Posts

Aptose’s Tuspetinib Triple Drug Therapy Featured at the 2025 ASH Annual Meeting; High Rate of Frontline Clinical Responses Continues Across AML Populations

TUS+VEN+AZA triplet frontline therapy demonstrates high rates of efficacy and MRD-negative remissions in newly diagnosed…

4 hours ago

Disc Medicine Presents Positive Initial Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 67th American Society of Hematology (ASH) Annual Meeting

Demonstrated meaningful overall anemia responses across all patient subgroups, regardless of baseline transfusion status Anemia response…

4 hours ago