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, 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.
Krystal Biotech reported financial results for Q1 2021, highlighting a strong balance sheet with cash, cash equivalents, and short-term investments totaling $403.4 million. The company completed enrollment in the pivotal GEM-3 study for B-VEC in dystrophic epidermolysis bullosa (DEB). Anticipated top-line data is expected in 4Q21. Additionally, Krystal is on track to provide updates for their KB105 and KB407 programs in 1H21 and 3Q21, respectively. Notably, R&D expenses increased to $6.2 million, and the net loss for the quarter was $15.8 million ($0.74 per share).
Krystal Biotech (NASDAQ: KRYS) has appointed Andy Orth as Chief Commercial Officer. With over 25 years of experience in biotechnology, Orth previously led U.S. operations at Alnylam Pharmaceuticals. His expertise in launching genetic medicines is seen as vital for Krystal’s growth, especially for its investigational program B-VEC aimed at treating dystrophic epidermolysis bullosa (DEB). The company aims to enhance its commercial capabilities to bring essential treatments to patients.
On April 27, 2021, Krystal Biotech (NASDAQ: KRYS) announced a digital poster presentation at the American Society of Genetic & Cell Therapy (ASGCT) Annual Meeting from May 11-14, 2021. The presentation will showcase preclinical data from its vector-encoded antibody platform, highlighting in vitro efficacy with KB501 and KB502 targeting antibodies for atopic dermatitis. The session is scheduled for May 11, 2021. Suma Krishnan, COO of Krystal, emphasized the potential of their approach for treating chronic conditions.
Krystal Biotech (NASDAQ: KRYS) announced updates to the Statistical Analysis Plan for its Phase 3 GEM-3 study of B-VEC, a treatment for dystrophic epidermolysis bullosa (DEB), following FDA guidance. The randomized trial aims to evaluate the safety and efficacy of B-VEC, with 31 enrolled patients. Adjustments made include the primary outcome measure of complete wound healing at specific weeks and the use of the McNemar test for analysis. Previous studies showed promising results with a 78.6% healing rate in B-VEC treated wounds. The trial continues to be double-blind until data lock in Q4 2021.
Krystal Biotech (NASDAQ: KRYS) announced positive results from a GLP toxicology study of its inhaled gene therapy KB407 for cystic fibrosis, showing it was well-tolerated in nonhuman primates. Key findings include a high No-Observed-Adverse-Effect Level (NOAEL) and successful distribution in lung tissues. The company is also advancing KB408 for alpha-1 antitrypsin deficiency, with promising initial preclinical results. Krystal plans to initiate a Phase 1 study of KB407 in 3Q21 and will present more detailed data for KB408 at an upcoming scientific conference.
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