OnKure Therapeutics, Inc. (NASDAQ: OKUR) is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapies for fibrotic diseases and oncology. The company leverages an integrated, data-driven platform that combines target identification, machine learning and functional screening to accelerate the selection of small molecules and biologics with the potential to reverse fibrosis or modulate the tumor microenvironment. OnKure’s approach is designed to address high-unmet-need diseases where current treatment options are limited.
OnKure’s pipeline includes ONK-002, a first-in-class small molecule targeting key drivers of liver fibrosis in nonalcoholic steatohepatitis (NASH); ONK-004, an orally administered agent aimed at attenuating fibrotic scarring across multiple organ systems; ONK-501, a selective apoptosis inducer in Phase I development for pancreatic adenocarcinoma; and ONK-103, a next-generation immuno-modulator advancing through IND-enabling studies. Each program is supported by biomarker-driven patient stratification strategies to optimize clinical development and therapeutic impact.
Headquartered in Cambridge, Massachusetts, OnKure maintains research facilities in North America and Europe, fostering collaborations with academic institutions, contract research organizations and strategic industry partners. The company’s global footprint enables it to conduct multi-site clinical trials and to tap into specialized expertise in fibrosis biology, oncology drug development and translational sciences.
Founded in 2015 and publicly listed following a business combination in 2023, OnKure is led by a management team with extensive experience in pharmaceutical R&D, clinical development and regulatory affairs. The senior leadership includes seasoned executives who have held senior roles at leading biotechnology and pharmaceutical companies, providing deep expertise in target validation, clinical operations and commercialization planning.
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