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.
About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company headquartered in Pittsburgh, Pennsylvania, specializing in the discovery, development, and commercialization of innovative genetic medicines. The company leverages its proprietary HSV-1-based gene therapy platform, STAR-D, to address rare and debilitating diseases with high unmet medical needs. Krystal Biotech's approach emphasizes redosable, non-invasive therapies, distinguishing it within the gene therapy landscape.
Core Business Areas
Krystal Biotech's operations span multiple therapeutic areas, including dermatology, respiratory, oncology, ophthalmology, and aesthetics. Its flagship product, VYJUVEK®, is the first-ever FDA-approved redosable gene therapy for dystrophic epidermolysis bullosa (DEB), a rare genetic skin disorder. This topical therapy exemplifies the company's commitment to addressing the root causes of genetic diseases through molecular-level interventions.
Proprietary Technology Platform
The company's proprietary STAR-D platform utilizes a modified herpes simplex virus type 1 (HSV-1) vector to deliver therapeutic genes directly to target cells. This platform enables the development of redosable therapies, overcoming traditional gene therapy limitations related to immune responses and durability. Krystal Biotech is actively expanding the platform's applications to include inhaled and injectable delivery methods for respiratory and oncology indications, respectively.
Pipeline and Market Impact
Krystal Biotech boasts a robust pipeline of genetic medicines targeting rare and underserved conditions. Key investigational candidates include:
- KB408: A genetic therapy for alpha-1 antitrypsin deficiency (AATD), delivered via inhalation.
- KB407: A therapy for cystic fibrosis, addressing the root genetic cause of the disease.
- KB707: A vectorized cytokine therapy for solid tumors, delivered through inhalation or intratumoral injection.
- KB301: An aesthetic treatment aimed at reversing skin aging by enhancing collagen production.
These programs underscore Krystal Biotech's versatility in addressing diverse medical challenges, from genetic skin disorders to complex oncology and respiratory conditions.
Competitive Landscape
Krystal Biotech operates in a highly competitive biotechnology sector, contending with other gene therapy companies and traditional pharmaceutical approaches. Its distinct focus on redosable therapies and its clinically validated HSV-1 platform provide a competitive edge. Additionally, its ability to address both rare diseases and broader market segments, such as aesthetics, enhances its market positioning.
Operational Excellence and Market Reach
With a strong foundation in research and development, Krystal Biotech demonstrates operational excellence through its streamlined clinical trials and regulatory achievements. The company has successfully commercialized VYJUVEK in the United States and is actively pursuing approvals in Europe and Japan, reflecting its global ambitions. Its wholly-owned subsidiary, Jeune Aesthetics, Inc., further extends its reach into the aesthetics market, leveraging the same innovative platform.
Significance in the Biotechnology Industry
Krystal Biotech represents a paradigm shift in gene therapy, offering solutions that are not only effective but also patient-friendly. Its focus on addressing the molecular causes of diseases, combined with its commitment to underserved patient populations, positions it as a leader in the genetic medicine field. By integrating scientific innovation with practical therapeutic applications, Krystal Biotech continues to make meaningful advancements in healthcare.
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.
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.
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