Clinical-stage oncology biotech developing targeted PI3K/AKT/mTOR inhibitor for solid tumors
Celcuity is a public clinical-stage biotech advancing gedatolisib, a potential first-in-class PAM pathway inhibitor for HR+/HER2- breast cancer and metastatic prostate cancer. The hiring mix—dominated by sales (11 roles) and healthcare (10 roles) with senior/director-level fills—signals an organization scaling toward Phase 3 readiness and commercialization rather than core drug discovery. Tech stack leans on regulatory and trial-management tools (Veeva, Medidata Rave, EudraVigilance, SAS) with active pain points in clinical site identification, trial conduct, and payer alignment, indicating execution friction common to late-stage development.
Notable leadership hires: Biostatistics Director, Medical Director
Celcuity develops targeted cancer therapies focused on solid tumors. The lead program, gedatolisib, is an intravenous PI3K/AKT/mTOR pathway inhibitor currently in Phase 3 development for hormone receptor-positive, HER2-negative advanced breast cancer (first- and second-line settings) and Phase 1b/2 evaluation in combination with darolutamide for metastatic castration-resistant prostate cancer. The company is headquartered in Minneapolis and operates as a publicly traded clinical-stage entity. Current operational focus spans clinical trial execution, site identification and education, commercial planning for territory rollout, and alignment with payer evidence requirements.
Gedatolisib, an intravenous PI3K/AKT/mTOR pathway inhibitor with Phase 3 programs in HR+/HER2- advanced breast cancer and Phase 1b/2 in metastatic castration-resistant prostate cancer with darolutamide.
Primary tools include Medidata Rave (trial data management), Veeva suite (quality and regulatory), EudraVigilance (pharmacovigilance), SAS and SQL (analysis), and Salesforce (CRM).
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