Krystal Biotech Inc（KRYS）资讯与事件KRYSKrystal Biotech Inc

Krystal Biotech Provides Clinical Update on KB113 Efficacy

Krystal Biotech announced a clinical update supporting initial proof of concept for KB113, an intratumoral immunotherapy designed to drive sustained, localized expression of interleukin-2, or IL-2, and interleukin-12, or IL-12, in the tumor microenvironment and promote systemic immune-mediated tumor clearance, in the treatment of basal cell carcinomas, or BCCs, in patients with Gorlin syndrome: broad antitumor responses were detected in all three Gorlin syndrome patients treated with KB113, with over 80% of assessed BCC lesions reducing in size; responses were observed in both injected and non-injected lesions, including substantial regression in lesions that were not directly injected with KB113, consistent with an abscopal effect; and complete clearance of an injected lesion was also confirmed histologically for each of the three patients treated with KB113. KB113 is the low dose of intratumoral KB707 that showed promising early efficacy signals in patients with BCC in the company's OPAL-1 Phase 1/2 study, an open label, multicenter, dose escalation and expansion Phase 1/2 study in patients with injection-accessible solid tumors. The Gorlin Syndrome Pilot Study was a multicenter, single-arm, open label study designed to evaluate the safety and preliminary efficacy of KB113 for the treatment of BCCs in patients with Gorlin syndrome. Three adult patients with Gorlin syndrome were enrolled in the study. All three patients received six doses of up to 2 mL of 108 PFU/mL KB113 over a period of 14 weeks, with the first two doses spaced two weeks apart followed by dosing once every three weeks. Landmark lesions, defined as facial BCCs greater than or equal to5 mm in diameter or non-facial BCCs greater than or equal to9 mm in diameter, were identified by the investigator and visually assessed for clinical regression throughout the 14-week treatment period and again 30 days after the final dose using a pre-specified, investigator-assessed 5-point clearance scale. The scale categorizes each lesion by magnitude of regression. Only landmark lesions were eligible for injection with KB113. The investigator selected which landmark lesions to inject, irrespective of anatomical location, and determined the injection volume for each lesion based on its clinical presentation. Regression of landmark lesions was observed as early as two weeks after initiation of treatment, with responses broadening and deepening over time. At the final assessment conducted 30 days after last dose, over 80% of all assessed landmark lesions had regressed. Over half of all landmark lesions demonstrated greater than 50% clinical regression, and a subset demonstrated at least 90% clinical regression, as assessed using the investigator-assessed 5-point clearance scale. Substantial regression was observed in lesions that had never been directly injected, providing preliminary evidence of an abscopal effect. To further assess clinical regression, one injected lesion from each patient that had achieved at least 90% clinical regression was biopsied. All three biopsied lesions demonstrated histologically confirmed complete response, with no evidence of residual tumor tissue. Consistent with prior experience in the low dose escalation cohort of OPAL-1, KB113 was well tolerated by all three patients enrolled in the Gorlin Syndrome Pilot Study. All reported adverse events were mild or moderate in severity, transient, and resolved during the study. The company has initiated discussions with the United States Food and Drug Administration (FDA) regarding the advanced clinical development of KB113 for the treatment of Gorlin syndrome. The Company will provide an update on its clinical development plans following alignment with the FDA.

Stock Futures Rise as Investors Improve Risk Appetite

Stock futures are higher as investors begin a new month with improving risk appetite after easing tensions in the Middle East sent oil prices sharply lower. Technology shares are helping lead the gains as investors look ahead to another busy week of corporate earnings and economic data.Geopolitical developments are driving sentiment after President Donald Trump announced a pause in military strikes against Iran and renewed diplomatic efforts aimed at reopening the Strait of Hormuz. Brent crude has fallen roughly 5% and U.S. crude has dropped below $80 per barrel. Treasury yields have also moved lower as investors scale back expectations for additional inflationary pressure from energy markets.Earnings season remains a catalyst, with investors awaiting results from Palantir after Monday's close, followed later this week by reports from AMD, McDonald's, Pfizer, Eli Lilly, Disney and Uber. The market is also preparing for SpaceX's first earnings report since its public listing. Recent results from Microsoft and Amazon have helped restore confidence in the AI trade, though investors remain sensitive to signs of rising capital expenditures and slowing returns on AI investments.Looking ahead, investors will monitor this week's economic calendar for fresh insight into the health of the U.S. economy. Friday's July employment report is expected to provide an important update on labor market conditions and could influence expectations for future Federal Reserve policy.In pre-market trading, S&P 500 futures rose 0.60%, Nasdaq futures rose 0.19% and Dow futures rose 1.20%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Atkoreup 28% after entering into a definitive agreement to be acquired by Prysmian in an all-cash transaction representing an enterprise value of approximately $3.8BFergusonup 8% ahead of its entry into the S&P 500Supernusup 15% after the company and Indivior entered into a definitive agreement to combine in a tax-free all-stock merger of equals transactionIndiviorup 4% after Supernus and the company entered into a definitive agreement to combine in a tax-free all-stock merger of equals transactionBristol Myersup 3% after Financial TimesAstraZenecais in discussions to combine with the company in a deal valued at nearly $400BDOWN AFTER EARNINGS -Sportradardown 17%Krystal Biotechdown 5%Marriottdown 2%LOWER -AstraZenecadown 7% after Financial Timesthe company is in discussions to combine with Bristol Myers Squibb in a deal valued at nearly $400BCircle Internet (CRCL) down 6% after Morgan Stanley downgraded the stock to Underweight with a price target of $38, down from $106

Krystal Biotech Q2 Revenue $119.22M, Below Consensus

Reports Q2 revenue $119.22M, consensus $121.04M. "Our second quarter reflects the strength of the Krystal model: a global commercial product that continues to perform, a strong balance sheet, and a pipeline now moving toward multiple registrational readouts," said Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech. "VYJUVEK is not only changing the standard of care for DEB patients around the world, it is also giving us the ability to advance high-conviction rare disease programs across the eye, lung, and skin with focus and discipline. We believe the next 12 to 18 months have the potential to mark an important transition for Krystal from a commercial success story to a multi-product genetic medicines company."