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, Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company headquartered in Pittsburgh, Pennsylvania, focused on genetic medicines for diseases with high unmet medical needs. Its news flow reflects the evolution of a gene therapy business built around VYJUVEK, the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for dystrophic epidermolysis bullosa, and a growing pipeline across respiratory, ophthalmology, dermatology, oncology, and aesthetics.
On this page, readers can follow KRYS news related to commercial performance and global launches of VYJUVEK, including label updates, reimbursement milestones, and market expansions in regions such as Europe and Japan. Company updates also cover strategic objectives for building a rare disease franchise, including plans to increase the number of marketed rare disease medicines and to reach more patients worldwide through direct launches and specialty distributor networks.
Investors and observers will find frequent clinical and regulatory news on Krystal Biotech’s pipeline programs. This includes interim data from studies such as CORAL‑1 for KB407 in cystic fibrosis, SERPENTINE‑1 for KB408 in alpha‑1 antitrypsin deficiency lung disease, IOLITE for KB803 in ocular complications of DEB, EMERALD‑1 for KB801 in neurotrophic keratitis, and oncology trials of KB707 in non‑small cell lung cancer. Updates often detail safety and molecular findings, study design progress, and interactions with regulators, such as FDA platform technology designation for the HSV‑1 vector used in KB801.
Krystal Biotech also regularly announces participation in major healthcare and investor conferences, quarterly financial results, and corporate guidance through press releases and SEC filings. This news page aggregates those disclosures so that users tracking KRYS stock can review earnings announcements, business updates, and key clinical milestones in one place.
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.
Krystal Biotech (NASDAQ: KRYS) has appointed Laurent Goux as General Manager of Europe, bringing over 20 years of experience in biotechnology. Previously a key player at Galderma, Goux has successfully launched multiple dermatologic medicines and will enhance Krystal’s commercial capabilities in Europe. This leadership change comes as the company advances its lead investigational program, B-VEC for DEB, and aims to build a fully integrated biotechnology company. Goux expressed enthusiasm for contributing to Krystal's mission of developing treatments for rare diseases.
Krystal Biotech, a leader in redosable gene therapies, announced it will present data on its product candidate, beremagene geperpavec (B-VEC), for treating dystrophic epidermolysis bullosa (DEB) at the DEBRA International Conference 2021. The data includes findings from a murine model demonstrating safety and collagen VII expression after B-VEC application. The U.S. FDA approved a compassionate use request for topical B-VEC in a DEB patient's eye following surgery. DEB currently lacks approved treatments for corneal lesions.
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