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Celcuity, Inc. is a clinical-stage biotechnology company focused on the development of targeted therapies for treatment of multiple solid tumor indications. Its CELsignia companion diagnostic platform is able to analyze live patient tumor cells to identify new groups of cancer patients to benefit from targeted therapies. Its lead therapeutic candidate is gedatolisib, a potent, small molecule dual inhibitor that selectively targets all Class I isoforms of PI3K and mammalian target of rapamycin (mTOR). Its mechanism of action and pharmacokinetic properties are highly differentiated from other investigational therapies that target PI3K or mTOR alone or together. Its initial clinical development program for gedatolisib focus on the treatment of patients with hormone receptor positive (HR+), HER2-negative, advanced or metastatic breast cancer. Its VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer.
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