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Krystal Biotech Announces First Quarter 2023 Financial Results and Operational Highlights
PDUFA date of May 19, 2023Presented clinical data at ARVO on topical application of B-VEC to the eye to treat ocular complications in a patient with recessive
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"PDUFA date of May 19, 2023Presented clinical data at ARVO on topical application of B-VEC to the eye to treat ocular complications in a patient with recessive dystrophic epidermolysis bullosa under Compassionate Use ProgramStrong balance sheet, closing the quarter with $355.5 million in cash, cash equivalents and investments PITTSBURGH, May 08, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today reported financial results and key operational progress updates for the first quarter ended March 31, 2023. “Krystal had a strong start to 2023, marked by significant progress in commercial preparation activities for our anticipated FDA approval of B-VEC later this month, as well as advancements across our pipeline, which lay the groundwork for long-term value creation,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. He added, “We are also encouraged by the remarkable vision improvements seen in the RDEB patient who was dosed with B-VEC topically in the eye to treat cicatrizing conjunctivitis under our compassionate use program, which supports expansion of our platform beyond skin and pulmonology into ophthalmological indications.” Dermatology B-VEC (beremagene geperpavec) for the treatment of Dystrophic Epidermolysis Bullosa (DEB) In January, the Company was notified by the U.S. Food & Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) date for the Company’s Biologics License Application for B-VEC for the treatment of patients with DEB, will be May 19, 2023. In April, the Company began labeling discussions with the FDA.The Company was informed by the European Medicines Agency in January 2023 to modify the Pediatric Investigation Plan (PIP) waiver request to include patients between birth and 6 months. The Company has modified and submitted the PIP waiver so that the Marketing Authorization Application procedure can officially start in the second half of 2023 with an approval expected in early 2024.The Company was informed by the Ministry of Health, Labour and Welfare (MHLW) of Japan that B-VEC was confirmed as safe for importation under the Cartagena Act. With the approval for the importation of B-VEC under the Cartagena Act, we intend to start an open ...