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 (Nasdaq:KRYS) has announced positive preclinical results for KB301, a novel gene therapy aimed at reversing collagen decline in aging skin. Findings will be presented at the ASDS 2020 Virtual Meeting on October 9-11, 2020. The study showed that KB301 effectively transduced human dermal fibroblasts, inducing full-length COL3 expression. In vivo results indicated dose-dependent COL3 expression in mice, with no toxicity or systemic distribution observed. This research is critical as Krystal prepares to advance KB301 through clinical trials.
Krystal Biotech (NASDAQ: KRYS) announces its participation in significant healthcare conferences. CEO Krish S. Krishnan will present at the HC Wainwright 22nd Annual Global Investments Conference on September 15, 2020, at 4:30 PM ET and will also participate in a fireside chat at the Morgan Stanley Global Healthcare Conference on September 16, 2020, at 5:00 PM ET. Both events will provide insights into Krystal’s innovative gene therapy developments. Webcasts of the presentations will be accessible for 30 days post-event on the company’s website.
Krystal Biotech (NASDAQ: KRYS) announced that the FDA has granted Orphan Drug Designation for its preclinical gene therapy product, KB407, targeting cystic fibrosis (CF). This designation supports the development of treatments for rare diseases affecting fewer than 200,000 individuals in the U.S. KB407 aims to provide non-invasive inhaled gene therapy, successfully delivering functional CFTR in cell studies. The company plans to file an IND in 2021, with marketing exclusivity and tax incentives available upon FDA approval.
Krystal Biotech (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will participate in a fireside chat at the William Blair BioTech Conference from August 4-6, 2020. The specific presentation is scheduled for August 6, 2020, at 11:00 a.m. ET. A webcast will be available for 30 days post-event on the company’s website. Krystal Biotech is focused on developing gene therapies for dermatological conditions, utilizing its proprietary HSV-1 platform. For more details, visit www.krystalbio.com.
Krystal Biotech has initiated the GEM-3 trial, a pivotal Phase 3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) patients. The trial is randomized and double-blind, involving around 30 patients for six months. B-VEC, a topical gene therapy, has shown positive results in earlier studies and is granted orphan drug and fast track designations by the FDA and EMA. The company expects to submit a Biologics License Application (BLA) in 2021, with a Marketing Authorization Application (MAA) soon after. Krystal's GMP facility is equipped to support the therapy's launch in the U.S.
Krystal Biotech (NASDAQ: KRYS) announced the appointment of Whitney Ijem as the Senior Vice President of Strategy and Business Development. Joining from Guggenheim Securities, Ijem brings extensive experience in genetic medicine. Her role aims to advance Krystal's efforts in treating rare skin and lung diseases using their proprietary HSV-1 platform. CEO Krish S. Krishnan expressed enthusiasm for Ijem’s addition, highlighting her strong industry connections and expertise.
Krystal Biotech (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast on June 10, 2020, at 1:20 p.m. ET. The presentation will highlight the company's transformative gene therapy developments aimed at treating protein or gene dysfunction-related diseases. A webcast will be accessible for 90 days post-event. For more details on Krystal's presentations, visit Krystal Biotech Website.
Krystal Biotech, Inc. (Nasdaq: KRYS) has announced the pricing of an underwritten public offering of 2,275,000 shares at $55.00 each, with gross proceeds expected to be about $125.1 million. The offering is set to close around May 21, 2020, and includes a 30-day option for underwriters to purchase an additional 341,250 shares. Proceeds will be used for advancing clinical trials and developing a manufacturing facility. Leading firms managing the offering include Cowen, Evercore ISI, and others.
Krystal Biotech (Nasdaq: KRYS) has announced an underwritten public offering of its common stock, granting underwriters a 30-day option for an additional 15% of shares. The offering is subject to market conditions and lacks definitive terms. Proceeds will fund the Phase 3 trial of KB103, advance KB105 development, and support clinical efforts for multiple other compounds. The company seeks to establish a certified manufacturing facility for its products and cover working capital needs. This offering is part of a shelf registration effective since May 4, 2020.
Krystal Biotech announced interim results from a Phase 1/2 clinical trial for KB105, targeting autosomal recessive congenital ichthyosis (ARCI). The treatment was well tolerated in three adult patients, with no adverse events reported. Notably, KB105 showed detectable TGM-1 expression in treated areas, indicating functional activity and reduced disease phenotype reversion. A Phase 2 study in pediatric patients is expected to begin in late 2020, aiming to further validate effectiveness using a new severity score scale.
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