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 a public offering of 1,923,077 shares at $65.00 per share, aiming to raise approximately $125 million. Underwriters have a 30-day option for an additional 288,461 shares. The funds will support pivotal trials for B-VEC, advance clinical development of KB105 and KB104, and bolster the respiratory pipeline. The offering is set to close around February 5, 2021, following customary conditions. Goldman Sachs, Cowen, and Evercore act as joint book-running managers.
Krystal Biotech Inc. (NASDAQ: KRYS) announced a $100 million underwritten public offering of its common stock, with a potential 15% increase in shares for underwriters. The funds will support ongoing clinical trials, including pivotal testing of B-VEC for DEB, and advance the development of therapies for cystic fibrosis and other rare diseases. The offering is contingent on market conditions and is conducted under a previously effective shelf registration statement.
Krystal Biotech (NASDAQ: KRYS) has appointed Dr. Chris Mason and Dr. Jing L. Marantz to its board of directors, enhancing its expertise in gene therapy and rare diseases. Dr. Mason, with over 25 years in cell and gene therapy, brings substantial R&D experience, while Dr. Marantz contributes over 20 years in the biopharmaceutical sector, specializing in medical affairs and commercial strategy. Their appointments are expected to bolster Krystal's efforts to advance its proprietary gene therapy technologies and tackle significant unmet medical needs.
Krystal Biotech Inc. (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx virtual conference, scheduled for December 1-3, 2020. The presentation will take place on December 1 at 1:50 p.m. ET. Interested parties can access the webcast via this link. A recording of the presentation will be available for 90 days on Krystal's website.
Krystal specializes in innovative gene therapies targeting rare skin and lung diseases.
Krystal Biotech (Nasdaq:KRYS) announces the departure of Chief Commercial Officer Jennifer Chien, effective immediately, as she pursues another opportunity. The company’s senior commercial team will report directly to CEO Krish Krishnan during the search for her replacement. Despite the leadership change, Krishnan expresses confidence in the continuity of pre-launch activities and states that the GEM-3 clinical trial is progressing as planned with early enrollment completion expected next year. Challenges from the COVID-19 environment have been managed effectively, maintaining patient enrollment across U.S. sites.
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.