KB707 - (KYANITE-1)

November 2, 2026: Krystal Biotech (NASDAQ: KRYS) reported 3Q 2026 results and a pipeline/commercial update. VYJUVEK for dystrophic epidermolysis bullosa generated $127.3 million in quarterly global revenue ($1.1 billion since launch); Germany and Italy pricing negotiations are complete, Italy launch is expected in early 2027, Spain reimbursement/pricing decisions are expected later in 2026, France no earlier than 2027, and marketing applications were submitted/planned for Australia and Switzerland.

Pipeline catalysts: KB111 (Hailey-Hailey disease) completed enrollment in HALITE-1 (5 patients), with interim data due before year-end 2026; FDA meeting is planned in 1Q 2027 to discuss results, a severity scale, and a registrational study start in 2027. KB113 (Gorlin syndrome-associated basal cell carcinoma) showed investigator-assessed regression in more than 80% of assessed lesions in a 3-patient pilot, including injected and non-injected lesions; histology confirmed complete clearance of one injected lesion per patient, and the company is discussing advanced development with FDA.

KB803 (corneal abrasions in DEB) now expects last patient visit in February 2027 and topline results shortly after. KB801 (neurotrophic keratitis) topline data are now expected in 2027. KB407 (cystic fibrosis) interim data are expected in 1H 2027; FDA CID discussions support a planned registrational study start in 2027. KB408 (AATD lung disease) interim data are expected in 2027. Inhaled KB707 in NSCLC previously showed ORR 31% and DCR 75% with pembrolizumab; a global chemotherapy-combination expansion is enrolling, targeting about 70 patients by mid-2027. The board also authorized up to a $400 million share repurchase program.