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

Key Takeaway: Krystal Biotech has successfully completed the sale of its Rare Pediatric Disease Priority Review Voucher for $100 million. This voucher was awarded by the FDA following the accelerated approval of VYJUVEKTM for treating dystrophic epidermolysis bullosa in patients aged six months and older. The voucher can expedite the review process for future marketing applications or be sold as practiced in the industry. The company continues to focus on its innovative genetic medicine portfolio addressing high unmet medical needs.

Market Sentiment Analysis

POSITIVE FACTORS

  • Krystal Biotech secures $100 million from the sale of a PRV.
  • This sale underscores the company's successful path in genetic medicine.
  • The FDA's approval of VYJUVEKTM highlights the company's innovation.
  • Krystal Biotech is advancing a strong clinical pipeline for various diseases.

Full Press Release Details

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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Frequently Asked Questions

What did Krystal Biotech sell for $100 million?

Krystal Biotech sold its Rare Pediatric Disease Priority Review Voucher for $100 million.

What is VYJUVEKTM used to treat?

VYJUVEKTM treats recessive or dominant dystrophic epidermolysis bullosa in patients over 6 months old.

What is the purpose of the PRV program?

The PRV program incentivizes the development of new drugs for rare pediatric diseases.

What is Krystal Biotech's main focus?

Krystal Biotech focuses on genetic medicines for diseases with significant unmet medical needs.

Where is Krystal Biotech located?

Krystal Biotech is headquartered in Pittsburgh, Pennsylvania.

Last updated: Aug 21, 2023