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, Inc. (NASDAQ: KRYS) is a pioneering commercial-stage biotechnology company specializing in the development of innovative gene therapies for skin diseases. Headquartered in Pittsburgh, Pennsylvania, the company leverages its proprietary gene therapy platform, known as STAR-D, to create revolutionary treatments for rare and orphan dermatological conditions caused by genetic mutations.
Krystal Biotech's flagship product, VYJUVEK, is a topical, non-invasive, and redosable gene therapy designed to treat dystrophic epidermolysis bullosa (DEB), a debilitating skin disease characterized by fragile, blistering skin. VYJUVEK delivers the COL7A1 gene directly to the skin, providing the cells with the template to produce normal collagen type VII, thereby addressing the root cause of the disease. This groundbreaking therapy is the first-ever redosable gene therapy approved by the FDA for DEB, marking a significant milestone in genetic medicine.
The company's robust pipeline includes several promising candidates such as KB407 for cystic fibrosis, KB408 for alpha-1 antitrypsin deficiency, and KB707, an innovative gene therapy for solid tumors. KB707 is notable for its dual-action mechanism, delivering genes encoding interleukin-12 (IL-12) and interleukin-2 (IL-2) to promote tumor clearance. This treatment has received Fast Track Designation from the FDA, reflecting its potential to meet critical unmet medical needs.
Krystal Biotech's commitment to scientific innovation and operational excellence extends to its aesthetic subsidiary, Jeune Aesthetics, Inc., which focuses on reversing the biology of aging and damaged skin.
Recent developments highlight Krystal Biotech's ongoing efforts to expand its global footprint. The company has submitted a Marketing Authorization Application for VYJUVEK to the European Medicines Agency, with a CHMP opinion anticipated in the second half of 2024. Additionally, VYJUVEK has been granted Orphan Drug Designation in Japan, underscoring its potential to address significant unmet medical needs in international markets.
Financial Performance: In 2023, Krystal Biotech reported significant financial growth, driven by the successful launch and robust demand for VYJUVEK in the U.S. market. The company achieved $50.7 million in net product revenue within six months of VYJUVEK's approval, supported by high patient and physician demand, broad access, and compliance.
Krystal Biotech continues to advance its clinical and preclinical pipeline, striving to deliver next-generation genetic medicines across various therapeutic areas, including respiratory, oncology, dermatology, ophthalmology, and aesthetics.
For more information, visit www.krystalbio.com and follow @KrystalBiotech on LinkedIn and Twitter.
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.
Krystal Biotech, Inc. (NASDAQ: KRYS) will participate in Chardan’s 6th Annual Genetic Medicines Conference in New York on October 3-4, 2022. CEO Krish Krishnan will be featured in a fireside chat and hold investor meetings on October 4. A webcast of the presentation will be available starting at 9:00 AM ET on that date, accessible through the Company's website. Krystal Biotech is a pivotal-stage gene therapy firm focused on developing innovative treatments for serious and rare diseases.
Krystal Biotech (NASDAQ: KRYS) announced a positive opinion from the European Medicines Agency (EMA) Pediatric Committee for its Pediatric Investigation Plan (PIP) regarding B-VEC, a gene therapy for dystrophic epidermolysis bullosa (DEB). This approval allows the company to proceed with its Marketing Authorization Application (MAA) without the need for additional studies. B-VEC has orphan drug and fast track designations from the FDA. The positive opinion paves the way for enhanced market exclusivity in the EU, critical for the company's growth strategy.
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