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.
On March 15, 2022, Krystal Biotech (NASDAQ: KRYS) announced a binding term sheet with PeriphaGen to settle trade secret litigation from May 2020. Krystal will acquire biological materials and skin assets from PeriphaGen for $25 million, payable within 10 days after a final settlement agreement, expected within 45 days. Additional milestone payments of $12.5 million will be required upon FDA approval of Krystal's first product and subsequent sales milestones. The settlement includes no admission of liability, and the case is expected to be dismissed within a month.
Krystal Biotech (NASDAQ: KRYS) reported positive news following its GEM-3 pivotal trial for Vyjuvek™, intended to treat dystrophic epidermolysis bullosa. The company plans to file a Biologics License Application (BLA) with the FDA in 1H 2022 and a Marketing Authorization Application (MAA) with the EMA in 2H 2022. Krystal is also set to start a Phase 1 trial for KB407, targeting cystic fibrosis in Australia by mid-2022. The firm maintains a strong financial position, with cash and investments totaling $502.5 million as of December 31, 2021.
Krystal Biotech (NASDAQ: KRYS) announced that CEO Krish S. Krishnan will participate in a fireside chat at Cowen’s 42nd Annual Health Care Conference held virtually from March 7-9, 2022. The chat is scheduled for March 7, 2022, from 2:50 to 3:20 p.m. EST. Investors can access the webcast link here. Krystal Biotech specializes in redosable gene therapy, aiming to develop treatments for serious diseases, including rare skin and lung conditions. For further details, visit the official website.
Krystal Biotech (NASDAQ: KRYS) has appointed Jing Marantz as Chief Business Officer and Rand Sutherland to its Board of Directors. Marantz brings over 20 years of experience in biopharmaceuticals, previously serving as Senior VP at Acceleron Pharma. Sutherland, a pulmonologist, has led R&D at Translate Bio and Sanofi. These appointments aim to enhance Krystal's capabilities in advancing their investigational program, VYJUVEK™ for dystrophic epidermolysis bullosa, and other rare diseases. The leadership changes come as the company seeks long-term success in gene therapy innovation.
Krystal Biotech (NASDAQ: KRYS) announced a public offering of 2,666,667 shares at $75.00 each, with gross proceeds expected to reach approximately $200 million. The offering, set to close around December 3, 2021, includes a 30-day option for underwriters to purchase an additional 400,000 shares. Proceeds will fund commercialization efforts for VYJUVEK, advance clinical and preclinical developments for other therapies, and enhance manufacturing capabilities. Goldman Sachs, BofA Securities, Cowen, and William Blair are managing the offering.
Krystal Biotech (NASDAQ: KRYS) has initiated a public offering of $200 million of its common stock, with underwriters granted a 30-day option for an additional $30 million. The proceeds will support commercialization of VYJUVEK for dystrophic epidermolysis bullosa and advance various clinical developments, including therapies for cystic fibrosis and Netherton syndrome. The offering, underpinned by a shelf registration statement filed with the SEC, is subject to market conditions.
Krystal Biotech announced positive results from the pivotal GEM-3 trial of its gene therapy VYJUVEK for treating dystrophic Epidermolysis Bullosa (dystrophic EB). The trial met its primary endpoint, showing a 67% complete wound healing rate at six months compared to 22% for the placebo group. The Biologics License Application (BLA) is set for submission to the FDA in 1H22. VYJUVEK was well tolerated, with no serious adverse events. The success of this trial emphasizes the potential of VYJUVEK to transform treatment for this severe condition.
Krystal Biotech, Inc. (NASDAQ: KRYS) reported strong operational progress and financial results for Q3 2021 with a cash position of $362.3 million as of September 30. The company is on track to release top-line data from its pivotal GEM-3 study for Dystrophic Epidermolysis Bullosa (DEB) in 4Q21. Other highlights include completed enrollment in the PEARL-1 study and progress on its second manufacturing facility, expected to be operational in 2022. However, net losses increased to $(15.6 million) for Q3.
Krystal Biotech announced the completion of the 26-week dosing period and safety follow-up for its pivotal Phase 3 GEM-3 clinical trial evaluating beremagene geperpavec (B-VEC) as a treatment for dystrophic epidermolysis bullosa (DEB). A total of 31 patients participated, with 29 completing the study without missing visits. Topline results are expected in Q4 2021, with potential FDA and EMA regulatory filings planned if the data is positive. The trial aims to provide a topical, genetically corrective therapy for DEB, a severe genetic skin condition.
Krystal Biotech (NASDAQ: KRYS) announced the presentation of pre-clinical data on KB407, a redosable gene therapy for cystic fibrosis, at the North American Cystic Fibrosis Conference. The data highlighted results from an IND-enabling GLP toxicology study. The company received approval for a Phase 1 clinical trial of inhaled KB407 in Australia and plans to initiate a clinical trial in the U.S. in 2022. KB407 targets the underlying genetic cause of cystic fibrosis, addressing a significant unmet medical need for patients not responsive to current therapies.