Welcome to our dedicated page for Krystal Biotech news (Ticker: KRYS), a resource for investors and traders seeking the latest updates and insights on Krystal Biotech stock.
Krystal Biotech reports news on its commercial genetic-medicines business, led by VYJUVEK, a redosable gene therapy approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa. Company updates commonly cover VYJUVEK revenue and global commercialization, manufacturing and platform developments, and regulatory actions tied to its HSV-1-based gene delivery technology.
Recurring clinical and scientific updates address investigational programs including KB407 for cystic fibrosis, KB707 for advanced or metastatic non-small cell lung cancer, KB111 for Hailey-Hailey disease, KB803 for corneal abrasions in DEB patients, and additional HSV-1-based vectors. News also includes quarterly operating results, conference presentations, FDA designations, and investor-event participation.
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On April 23, 2023, at the ARVO Annual Meeting, Krystal Biotech (NASDAQ: KRYS) presented promising data on the compassionate use of its gene therapy B-VEC for treating dystrophic epidermolysis bullosa (DEB) patients with ocular complications. The therapy, administered to a patient with recurrent cicatrizing conjunctivitis, showed significant results: full corneal re-epithelization within three months and improved visual acuity from hand motion to 20/40 at seven months. No drug-related adverse events were reported, underscoring the safety of B-VEC. With ocular complications affecting over half of DEB patients, this innovative treatment may address an urgent need in this underserved population, prompting the company to engage with regulatory authorities for further exploration of B-VEC’s applications.
Krystal Biotech (NASDAQ: KRYS) announced the upcoming presentation of new clinical data regarding the compassionate use of B-VEC for a patient with dystrophic epidermolysis bullosa (DEB) experiencing recurrent cicatrizing conjunctivitis. This presentation will occur during the ARVO 2023 Annual Meeting from April 23-27, 2023, in New Orleans, LA. The presentation, titled 'Topical beremagene geperpavec (B-VEC) for the treatment of recurrent cicatrizing conjunctivitis in a patient with DEB', will be delivered by Alfonso L. Sabater, M.D., PhD of the University of Miami Health System on April 23 from 12:00 PM to 1:45 PM CST.
Attendees can view the poster at the conference, and additional materials will be available online at the Company's website following the event.
Krystal Biotech (NASDAQ: KRYS) appointed Catherine Mazzacco to its Board of Directors. Her extensive background in the pharmaceutical industry, including roles at LEO Pharma and GE HealthCare, is expected to enhance the company's strategic objectives. CEO Krish S. Krishnan emphasized the importance of her experience in guiding Krystal's evolution as it advances its genetic medicines pipeline for rare diseases. Mazzacco expressed enthusiasm for contributing to the company's commercialization efforts and pipeline progression, aiming to transform lives with innovative treatments.
Krystal Biotech, Inc. (NASDAQ: KRYS) announced its participation in the 43rd Annual TD Cowen Health Care Conference in Boston from March 6-8, 2023. CEO Krish S. Krishnan will hold a fireside chat and investor meetings on March 7 at 10:30 AM ET. The presentation will be webstreamed live, with an archived version available afterward on the company’s website. Krystal Biotech focuses on developing genetic medicines for rare diseases and operates a diverse pipeline using its proprietary redosable HSV vector. Headquartered in Pittsburgh, it boasts capabilities in viral vector design and gene therapy manufacturing.
Krystal Biotech (KRYS) reported key updates and financial results for Q4 and the full year 2022 on February 27, 2023. The company has a strong cash position, ending the year with $383.8 million in cash and investments. The PDUFA date for its B-VEC treatment for Dystrophic Epidermolysis Bullosa is set for May 19, 2023. The pivotal Phase 3 trial data of B-VEC was published in the New England Journal of Medicine. Krystal plans to initiate four new clinical trials in 2023 and aims to operationalize its second manufacturing facility, ASTRA, early this year.
On January 18, 2023, Krystal Biotech (NASDAQ: KRYS) announced that the European Commission has granted orphan designation for its investigational gene therapy, KB407, targeting Cystic Fibrosis (CF). This therapy aims to directly deliver the CFTR gene to lung cells, potentially restoring normal function regardless of genetic mutations. The U.S. Food and Drug Administration has also granted orphan drug status to KB407. The designation allows for funding and regulatory incentives, including a 10-year marketing exclusivity period in the EU. CEO Suma Krishnan expressed optimism about advancing treatment options for CF patients.
Krystal Biotech, Inc. (NASDAQ: KRYS) announced a revised PDUFA date of May 19, 2023 for its B-VEC application, following additional manufacturing information submitted on December 20, 2022. The FDA classified this as a major amendment requiring more review time. An earlier late-cycle review meeting confirmed no Advisory Committee meeting is needed. B-VEC is an investigational gene therapy for Dystrophic Epidermolysis Bullosa, aiming to provide functional COL7A1 gene copies to patients. The company remains committed to its commercial readiness efforts.
Krystal Biotech (NASDAQ: KRYS) announced pivotal Phase 3 trial results for its gene therapy, B-VEC, targeting dystrophic epidermolysis bullosa (DEB). The trial, published in NEJM, showed complete wound healing in 67.4% of B-VEC treated wounds at 6 months versus 21.6% for placebo, with significant healing also at 3 months. B-VEC, designed to deliver the COL7A1 gene, has received FDA acceptance for a Biologics License Application with a Priority Review designation, aiming for approval by February 17, 2023. The treatment could drastically improve the quality of life for DEB patients.