Krystal Biotech Stock Price, News & Analysis

Krystal Biotech (NASDAQ: KRYS) announced that it will allow patients with dystrophic epidermolysis bullosa (DEB) in the GEM-3 open-label extension study to receive treatment at home by a healthcare professional. This decision, based on FDA feedback, aims to ease patient burden and enhance compliance. The company plans to incorporate home dosing into its Biologics License Application (BLA) submission anticipated in Q2 2022. The GEM-3 study, which began in May 2021, aims to assess the long-term safety of the investigational gene therapy B-VEC.

Krystal Biotech, Inc. (NASDAQ: KRYS) recently announced promising results from the Phase 1 and 2 study of its investigational topical gene therapy, B-VEC, for treating dystrophic epidermolysis bullosa (DEB). The treatment showed robust functional COL7 expression and significantly improved durable wound closure compared to placebo, with minimal adverse events reported. This marks a potential breakthrough in corrective treatment options for DEB patients, previously limited to palliative care. The therapy has received various designations from the FDA and EMA, highlighting its potential impact on severe skin diseases.

Krystal Biotech (NASDAQ: KRYS) presented detailed results from the GEM-3 Phase 3 study of its investigational gene therapy, B-VEC, at the 2022 American Academy of Dermatology Annual Meeting. The study evaluated B-VEC's safety and efficacy for treating dystrophic epidermolysis bullosa (DEB) in 31 patients. Results showed a significant increase in complete wound healing compared to placebo at both 3 and 6 months (p < 0.005). B-VEC is designed to deliver the COL7A1 gene non-invasively, addressing DEB's molecular mechanisms. An investor call will discuss these findings on March 28, 2022.

Krystal Biotech (NASDAQ: KRYS) announced that its CEO, Krish S. Krishnan, will participate in two upcoming conferences: H.C. Wainwright's Gene Therapy and Gene Editing Conference on March 30, 2022, at 7:00 a.m. EDT and Guggenheim's 3rd Annual Genomic Medicines and Rare Disease Day on March 31, 2022, from 2:00 to 2:45 p.m. EDT. Webcasts of the presentations will be available, with links to access them provided in the press release. Krystal Biotech focuses on redosable gene therapy for serious diseases, leveraging proprietary technology for potential life-changing treatments.

Krystal Biotech (NASDAQ: KRYS) will showcase late-breaking research on March 26, 2022, at the American Academy of Dermatology Annual Meeting in Boston. The presentation focuses on Phase 3 study results of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa (DEB), a rare and severe skin disease. B-VEC is an investigational topical gene therapy designed to address the genetic causes of DEB by delivering a functional COL7A1 gene. With orphan drug and fast track designations from the FDA, B-VEC aims to provide crucial treatment for DEB patients.

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.