Krystal (KRYS) Up 5% on Sale of FDA's Priority Review Voucher
Krystal Biotech, Inc. KRYS announced completing the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million. Shares of KRYS jumped 5.2% on Aug 21, 2023, as investors anticipate an influx of cash into the company’s balance sheet.
Krystal received the PRV from the FDA in May 2023, upon the approval of Vyjuvek for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa (DEB). Notably, DEB is a rare genetic disorder that results in the deficiency of functional type VII collagen (COL7) protein and is caused by one or more mutations in the COL7A1 gene.
The lack of this protein in DEB patients causes extremely fragile skin that blisters and tears with minor friction or trauma. DEB patients suffer from open wounds, which lead to recurrent skin infections and fibrosis that can cause fusion of fingers and toes, and in the worst-case scenario, increase the risk of developing an aggressive form of skin cancer.
Year to date, shares of Krystal have shot up 58.5% against the industry’s 13.1% fall.
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Per the FDA’s Rare Pediatric Disease program, companies are awarded the PRV when its pediatric disease product applications meet certain criteria. The purpose of the program is to encourage companies to develop new drugs that prevent or treat rare pediatric diseases. When awarded, a company holds the option to either redeem the voucher to receive priority review of a subsequent marketing application or sell/transfer the same.
KRYS’ Vyjuvek is a topical gel, which addresses the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing. Vyjuvek is the first-ever redosable gene therapy and currently forms the first and only medicine approved by the FDA for the treatment of DEB, both recessive and dominant.
The FDA approval of Vyjuvek was based on positive results from two studies, the GEM-1/2 study and GEM-3 study.
The company anticipates the commercial launch of Vyjuvek in the United States in the third quarter of 2023.
Krystal Biotech, Inc. Price and Consensus
Krystal Biotech, Inc. price-consensus-chart | Krystal Biotech, Inc. Quote
Zacks Rank and Stocks to Consider
Krystal Biotech currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the pharma/biotech sector are J&J JNJ, Corcept Therapeutics CORT and Dynavax Technologies DVAX, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for J&J’s 2023 earnings per share has increased from $10.67 to $10.75. During the same period, the estimate for JNJ’s 2024 earnings per share has increased from $11.01 to $11.30. Shares of JNJ have lost 2.2% in the past month.
JNJ beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.58%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 66 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 64 cents to 83 cents. Shares of CORT have climbed 29.3% in the past month.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 90 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 56 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Shares of DVAX have risen by 3.6% in the past month.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
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