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.
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 The presentation will be webstreamed live, with an archived version available afterward on the company’s website.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.
PITTSBURGH, Dec. 5, 2022 – Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), announced its participation in the Cantor Fitzgerald Medical and Aesthetic Dermatology Conference on December 8 in Miami. Senior VP September Riharb will join a panel titled Distraction or Destruction: What’s New/Next in the Industry at 11:00 am ET. The management team will also engage in investor meetings that day. Jeune focuses on reversing aging skin through a gene-delivery platform.
Krystal Biotech, Inc. (NASDAQ: KRYS) announced its participation in the BofA Securities 2022 Biotech SMID Cap Conference, scheduled for December 7-8, 2022. CEO Krish S. Krishnan will conduct a fireside chat and host investor meetings on December 7. A live audio webcast of the presentation will be accessible at 2:20 PM ET on December 7, with an archived version available later on the company's website. Krystal focuses on developing genetic medicines for rare diseases using its proprietary redosable HSV vector, showcasing a strong commitment to innovation in biotechnology.
Krystal Biotech, Inc. (NASDAQ: KRYS) announced its participation in the Evercore ISI 5th Annual HealthCONx Conference, scheduled from November 29 to December 1, 2022. CEO Krish S. Krishnan will engage in a fireside chat and conduct investor meetings on November 30. A webcast of the presentation will be available at 10:30 am ET on November 30, and further details can be found on the Company’s investor website.
Krystal focuses on developing genetic medicines for rare diseases, leveraging its proprietary redosable HSV vector technology.
Krystal Biotech's subsidiary, Jeune Aesthetics, announced positive results from the PEARL-1 study extension cohort of KB301, a gene-based treatment for aging skin. Patients aged 55 to 76 showed durability of effect for up to nine months after treatment, with mean Subject Satisfaction Scores improving by 1.6 to 1.85 points. The company plans to initiate a Phase 2 trial in the first half of 2023 to evaluate KB301's efficacy against fine lines and wrinkles. The extension cohort also demonstrated that 62-70% of subjects reported meaningful improvements post-treatment.
Krystal Biotech received FDA acceptance for its B-VEC Biologics License Application, with a Priority Review and a PDUFA target date of February 17, 2023, for treating dystrophic epidermolysis bullosa (DEB). The company was informed that no Advisory Committee meeting is needed following a mid-cycle review. It also received a positive opinion from EMA's Pediatric Committee for B-VEC and plans to submit a marketing authorization application in Q4 2022. As of September 30, 2022, Krystal Biotech reported a strong financial position with $407 million in cash and sustained clinical trial advancements.