Business
Krystal Biotech Announces Second Quarter 2023 Financial Results and Operational Highlights
• VYJUVEK™ approved in the U.S. as the first and only topical redosable gene therapy for the treatment of dystrophic epidermolysis bullosa • 121 Patient Start
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"• VYJUVEK™ approved in the U.S. as the first and only topical redosable gene therapy for the treatment of dystrophic epidermolysis bullosa • 121 Patient Start Forms in the first six weeks of launch • First cystic fibrosis patient dosed in Phase 1 Clinical Trial of KB407 • IND for KB707, Krystal’s first oncology candidate for solid tumors, accepted by FDA and granted Fast Track Designation • Strong balance sheet, closing the quarter with $505.9 million in cash, cash equivalents and investments PITTSBURGH, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today reported financial results and key operational progress updates for the second quarter ended June 30, 2023. “2023 is off to a very strong start and we expect the momentum to continue for the rest of the year. In the first half of the year, we received FDA approval for VYJUVEK, dosed our first patient in the cystic fibrosis trial and obtained IND clearance for our first oncology candidate,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “I am particularly thrilled with the enthusiasm that physicians and patients are expressing for VYJUVEK in these early days of launch. With 121 Patient Start Forms in the first six weeks since approval, I am pleased with the initial pace of the launch, and we look forward to promptly initiating treatment for these patients.” VYJUVEKTM On May 19, the Company announced that VYJUVEK (beremagene geperpavec-svdt, or B-VEC) was approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients six months of age or older with either recessive or dominant dystrophic epidermolysis bullosa (DEB) to be administered by a healthcare professional either in a healthcare professional setting (e.g., clinic) or a home setting.As of June 30, the Company received 121 Patient Start Forms of which 30 start forms were generated for patients with dominant dystrophic epidermolysis bullosa. The Company will continue to report on the number of Patient Start Forms submitted to the Company for the first three quarters following VYJUVEK approval and will transition to reporting on the number of Patients on Therapy beginning in the first...