Krystal Biotech Stock Price, News & Analysis

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.

Krystal Biotech and GeneDx have launched the Krystal Decode DEB™ program, providing no-charge genetic testing for Epidermolysis Bullosa (EB), specifically the dystrophic form known as DEB. This collaboration aims to accelerate diagnosis, allowing quicker access to optimal care. The program is designed for US residents presenting EB symptoms who haven't undergone genetic testing. It utilizes a comprehensive gene panel to aid in accurate diagnosis, addressing the significant diagnostic delays often faced by patients. This initiative has the potential to improve patient outcomes significantly.

Krystal Biotech (NASDAQ: KRYS) announced its participation in the Chardan Virtual 5th Annual Genetic Medicines Conference on October 4-5, 2021. CEO Krish Krishnan will engage in a fireside chat, while SVP Whitney Ijem will join a panel on non-traditional viral vectors on October 5. The fireside chat is scheduled for 11:00 AM ET, following the panel at 9:30 AM ET. Interested parties can access live webcasts through the provided links, with replays available for 30 days post-event. Krystal Biotech focuses on developing therapies for rare diseases using its innovative gene therapy platform.

Krystal Biotech has received approval from the Bellberry Human Research Ethics Committee in Australia for a Phase 1 clinical trial of its investigational inhaled gene therapy, KB407, aimed at treating cystic fibrosis (CF). This therapy delivers the CFTR gene to lung cells via nebulization. Enrollment for the trial is expected to start soon, following additional institutional approvals. The study will assess safety and tolerability, focusing on lung function improvements over three dosing cohorts. The company's efforts follow COVID-related delays, with plans to initiate a US trial in 2022.