NASDAQ — Healthcare: Manufacturing, Biotechnology: Biological Products (No Disgnostic Substances)
www.krystalbio.comThe company will showcase its research through a poster presentation at the ASCO Annual Meeting.
conference talkKrystal Biotech plans to launch VYJUVEK in Germany in mid-2025, following its recent approval for treating DEB from birth in Europe.
product launchKrystal Biotech will present a poster at the ARVO Annual Meeting, focusing on its advancements in vision research.
conference talkKrystal Biotech will present preclinical data on its HSV-1-based gene therapy platform, including investigational candidates KB111 and KB112 for Hailey-Hailey and Darier diseases, at the Society for Investigative Dermatology (SID) 2025 Annual Meeting in Pittsburgh. The company’s platform, which underpins the approved B-VEC therapy for dystrophic epidermolysis bullosa, is being expanded to address additional rare genetic skin disorders. KB111 and KB112 are topical gene therapies designed to restore ATP2C1 and ATP2A2 function, respectively, in keratinocytes. The presentation will cover efficacy and safety data from in vitro and animal studies.
conference talkThe final decision from the European Commission regarding the approval of VYJUVEK for treating DEB is anticipated in Q2 2025, following a positive recommendation from the CHMP.
fda decisionKrystal Biotech is conducting a natural history study of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB), with trial completion anticipated by July 1, 2025. The study aims to characterize the frequency and duration of corneal abrasions in DEB patients using remote symptom diaries and monthly questionnaires. Enrollment is set at 40 participants. Results may inform future therapeutic development for ocular complications in DEB.
trial completionKrystal Biotech is conducting a Phase 1/2 clinical trial of KB304, an investigational gene therapy for moderate to severe wrinkles in the décolleté region in women. KB304 uses a genetically engineered HSV-1 vector to deliver human collagen and elastin genes via injection. The randomized, double-blind study is expected to complete by August 1, 2025, with 21 participants. Trial results may inform further development of KB304 for aesthetic dermatology applications.
trial completionKrystal Biotech is conducting a Phase 1 clinical trial of KB408, a gene therapy using a non-integrating HSV-1 vector to deliver functional SERPINA1 for adults with Alpha-1 Antitrypsin Deficiency (AATD). The study, which began in February 2024, is evaluating safety and pharmacodynamics across three dose levels in patients with PI*ZZ or PI*ZNull genotypes. Trial completion is anticipated by May 1, 2026. KB408 is administered via nebulization and aims to address the underlying genetic deficiency in AATD, a rare inherited disorder.
trial completionKrystal Biotech is conducting a Phase 1/2 clinical trial of KB707, a genetically modified herpes simplex virus designed to stimulate anti-tumor immune response in patients with advanced or refractory solid tumors, including melanoma. The trial, which began in October 2023, is expected to complete on July 1, 2027. The study will assess safety, tolerability, and preliminary efficacy, with both dose escalation and expansion phases, and includes combination therapy with immune checkpoint inhibitors. KB707 is an investigational oncolytic virus therapy.
trial completionKrystal Biotech is conducting a Phase 1/2 clinical trial of KB707, a replication-defective HSV-1 vector designed to stimulate anti-tumor immune response in advanced solid tumor malignancies affecting the lungs. The study, expected to complete on February 1, 2028, evaluates safety, tolerability, and preliminary efficacy of KB707 as monotherapy and in combination with Keytruda, with or without chemotherapy, in adults with advanced non-small cell lung cancer (NSCLC) who have limited treatment options.
trial completion