February 26, 2024 (Globalinvestorideas.com Newswire) Biotech Stock News Bites – Krystal Biotech, Inc. (NASDAQ: KRYS), a commercial-stage biotechnology company reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.

“2023 was an inflection point for Krystal with the approval and launch of VYJUVEK, the first-ever FDA approved therapy for dystrophic epidermolysis bullosa and only medicine that delivers the corrective power of gene therapy in an easy-to-apply, redosable, topical gel formulation that can be administered at home,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “Our U.S. commercial launch trajectory is tracking closely to that of the best recent rare disease launches with $50.7 million in net product revenue only six months since approval, supported by high patient and physician demand, broad access, and high compliance. We look forward to expanding VYJUVEK access in the U.S. and globally in the years to come, while advancing our clinical pipeline and reinforcing our leadership in redosable gene therapy.”

VYJUVEK for the treatment of Dystrophic Epidermolysis Bullosa (DEB)

The Company recorded $42.1 million and $50.7 million in VYJUVEK U.S. net product revenue for the fourth quarter and full year 2023, respectively. Gross margin for the fourth quarter was 93%.

As of February 2024, the Company had secured 35% of the 1,200 identified patient base in patient start forms, as well as 228 reimbursement approvals for VYJUVEK while patient compliance with once weekly treatment while on drug was 96% at end of December 2023 and continues to remain high to date.

In January 2024, the Company received a permanent J-code (J3401) for VYJUVEK, which facilitates efficient and accurate billing and reimbursement, including under U.S Medicaid plans. As of February 2024, positive access has been achieved for 97% of lives covered under commercial plans and 88% of lives covered under Medicaid.

In November 2023, the European Medicines Agency validated the Company’s Marketing Authorization Application (MAA) for B-VEC for the treatment of DEB in patients from birth, and the MAA is now under review with a decision anticipated in 2H 2024.

In December 2023, B-VEC was granted Orphan Drug Designation (ODD) status for the treatment of DEB by the Japan Ministry of Health, Labour and Welfare, a designation which confers specific benefits, including priority review of applications, extended registration validity, and reduced development costs. The Company is conducting a fully enrolled open label extension study of B-VEC in Japan to support regulatory approval. Details of the study can be found at jrct.niph.go.jp under JRCT ID jRCT2053230075. The Company anticipates filing a Japan New Drug Application in 2H 2024 enabling a potential authorization in 2025.

Read the company’s full news and disclaimer here:


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