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 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.
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