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.
Krystal Biotech and GeneDx have launched the Krystal Decode DEB™ program, providing no-charge genetic testing for Epidermolysis Bullosa (EB), specifically the dystrophic form known as DEB. This collaboration aims to accelerate diagnosis, allowing quicker access to optimal care. The program is designed for US residents presenting EB symptoms who haven't undergone genetic testing. It utilizes a comprehensive gene panel to aid in accurate diagnosis, addressing the significant diagnostic delays often faced by patients. This initiative has the potential to improve patient outcomes significantly.
Krystal Biotech (NASDAQ: KRYS) announced its participation in the Chardan Virtual 5th Annual Genetic Medicines Conference on October 4-5, 2021. CEO Krish Krishnan will engage in a fireside chat, while SVP Whitney Ijem will join a panel on non-traditional viral vectors on October 5. The fireside chat is scheduled for 11:00 AM ET, following the panel at 9:30 AM ET. Interested parties can access live webcasts through the provided links, with replays available for 30 days post-event. Krystal Biotech focuses on developing therapies for rare diseases using its innovative gene therapy platform.
Krystal Biotech has received approval from the Bellberry Human Research Ethics Committee in Australia for a Phase 1 clinical trial of its investigational inhaled gene therapy, KB407, aimed at treating cystic fibrosis (CF). This therapy delivers the CFTR gene to lung cells via nebulization. Enrollment for the trial is expected to start soon, following additional institutional approvals. The study will assess safety and tolerability, focusing on lung function improvements over three dosing cohorts. The company's efforts follow COVID-related delays, with plans to initiate a US trial in 2022.
Krystal Biotech (NASDAQ: KRYS) has appointed Laurent Goux as General Manager of Europe, bringing over 20 years of experience in biotechnology. Previously a key player at Galderma, Goux has successfully launched multiple dermatologic medicines and will enhance Krystal’s commercial capabilities in Europe. This leadership change comes as the company advances its lead investigational program, B-VEC for DEB, and aims to build a fully integrated biotechnology company. Goux expressed enthusiasm for contributing to Krystal's mission of developing treatments for rare diseases.
Krystal Biotech, a leader in redosable gene therapies, announced it will present data on its product candidate, beremagene geperpavec (B-VEC), for treating dystrophic epidermolysis bullosa (DEB) at the DEBRA International Conference 2021. The data includes findings from a murine model demonstrating safety and collagen VII expression after B-VEC application. The U.S. FDA approved a compassionate use request for topical B-VEC in a DEB patient's eye following surgery. DEB currently lacks approved treatments for corneal lesions.
Krystal Biotech (NASDAQ: KRYS) will present at the H.C. Wainwright 23rd Annual Global Investment Virtual Conference, occurring from September 13-15, 2021. The company specializes in redosable gene therapies for rare diseases.
The pre-recorded presentation will be available on-demand starting September 13 at 7:00 A.M. (ET). For attendees, the presentation will be accessible for 90 days via the Krystal Biotech website. Learn more about their innovative therapies and ongoing developments at their official site.
Krystal Biotech (NASDAQ: KRYS) announced its second quarter 2021 financial results, reporting a robust cash position of $389.1 million as of June 30, 2021, up from $271.3 million at year-end 2020. The company is advancing multiple clinical programs, including the pivotal GEM-3 trial for B-VEC targeting dystrophic epidermolysis bullosa, with top-line results expected in 4Q21. Additionally, it plans to initiate a Phase 1 study for inhaled KB407 for cystic fibrosis in 3Q21 and has advanced its KB301 program for aesthetic applications.
Krystal Biotech (NASDAQ: KRYS) announced updates from its Phase 1/2 trial of KB105 for treating autosomal recessive congenital ichthyosis (ARCI). The fourth patient data shows KB105 is well tolerated, with no adverse events or immune response. Significant phenotypic improvement was noted in treated areas, particularly in high-dose sites. The next Phase 2 cohort may include pediatric patients, with discussions on optimal dosing ongoing. These promising results build on prior findings of increased TGM-1 expression from three previous patients.
Krystal Biotech (NASDAQ: KRYS) announced its participation in two virtual investor conferences. The first is the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 11:20 AM ET. A webcast link for this event is available. The second conference is the LifeSci Partners Genetic Medicines Summit 2021, scheduled for June 22, 2021. Krystal is known for its innovative gene therapy platform aimed at treating rare diseases. For further details, visit krystalbio.com.
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