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 reports news on its commercial genetic-medicines business, led by VYJUVEK, a redosable gene therapy approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa. Company updates commonly cover VYJUVEK revenue and global commercialization, manufacturing and platform developments, and regulatory actions tied to its HSV-1-based gene delivery technology.
Recurring clinical and scientific updates address investigational programs including KB407 for cystic fibrosis, KB707 for advanced or metastatic non-small cell lung cancer, KB111 for Hailey-Hailey disease, KB803 for corneal abrasions in DEB patients, and additional HSV-1-based vectors. News also includes quarterly operating results, conference presentations, FDA designations, and investor-event participation.
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.