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 commercial-stage biotechnology company headquartered in Pittsburgh, Pennsylvania, focused on genetic medicines for diseases with high unmet medical needs. Its news flow reflects the evolution of a gene therapy business built around VYJUVEK, the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa, and a growing pipeline across respiratory, ophthalmology, dermatology, oncology, and aesthetics.
On this page, readers can follow KRYS news related to commercial performance and global launches of VYJUVEK, including label updates, reimbursement milestones, and market expansions in regions such as Europe and Japan. Company updates also cover strategic objectives for building a rare disease franchise, including plans to increase the number of marketed rare disease medicines and to reach more patients worldwide through direct launches and specialty distributor networks.
Investors and observers will find frequent clinical and regulatory news on Krystal Biotech’s pipeline programs. This includes interim data from studies such as CORAL‑1 for KB407 in cystic fibrosis, SERPENTINE‑1 for KB408 in alpha‑1 antitrypsin deficiency lung disease, IOLITE for KB803 in ocular complications of DEB, EMERALD‑1 for KB801 in neurotrophic keratitis, and oncology trials of KB707 in non‑small cell lung cancer. Updates often detail safety and molecular findings, study design progress, and interactions with regulators, such as FDA platform technology designation for the HSV‑1 vector used in KB801.
Krystal Biotech also regularly announces participation in major healthcare and investor conferences, quarterly financial results, and corporate guidance through press releases and SEC filings. This news page aggregates those disclosures so that users tracking KRYS stock can review earnings announcements, business updates, and key clinical milestones in one place.
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.
Krystal Biotech, Inc. (NASDAQ: KRYS) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference in New York from September 12-14, 2022. CEO Krish Krishnan will present and meet investors on September 13. A webcast of the presentation will be available at 2:30 PM ET on the same day and can be found on the company's website. Krystal Biotech focuses on redosable gene therapies for serious diseases, leveraging proprietary technology and in-house manufacturing capabilities.
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