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.
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.
Krystal Biotech (NASDAQ: KRYS) announced that the FDA has accepted its Biologics License Application (BLA) for B-VEC, a treatment for dystrophic epidermolysis bullosa (DEB). The application has received Priority Review status with a Prescription Drug User Fee Act (PDUFA) action date set for February 17, 2023. The FDA does not plan to hold an advisory committee meeting regarding this application. B-VEC, which has also received Fast Track and RMAT designations, aims to address the underlying causes of DEB by delivering the COL7A1 gene directly to wounds.
Krystal Biotech (NASDAQ: KRYS) announced that the FDA has accepted its Investigational New Drug (IND) application for KB407, a redosable gene therapy for cystic fibrosis (CF). Designed to treat all patients regardless of genetic mutation, KB407 aims to restore normal CFTR protein function in lung cells. The Phase 1 clinical trial will assess safety and tolerability in up to 20 adults with CF, using nebulized administration of the therapy. The trial is anticipated to commence in the second half of 2022, indicating a significant milestone for the company.
Krystal Biotech announced that the FDA has accepted its IND application for KB407, an investigational gene therapy for cystic fibrosis (CF). This therapy aims to treat all CF patients, regardless of their genetic mutation, by delivering two copies of the CFTR gene to lung cells. The Phase 1 clinical trial will assess the safety and tolerability of nebulized KB407 in up to 20 adult participants, with initiation expected in the second half of 2022. The treatment addresses a significant unmet need for roughly 10-15% of CF patients who lack effective disease-modifying options.
Krystal Biotech (NASDAQ: KRYS), a leader in redosable gene therapy, will participate in the William Blair Biotech Focus Conference 2022 on July 12-13 in New York. CEO Krish Krishnan will engage in a fireside chat and lead investor meetings on July 13. A webcast of the event will be available starting 9 AM ET on July 11. The company focuses on developing innovative therapies for serious diseases, particularly rare skin and lung conditions. For more information, visit Krystal Biotech's website.
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