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Gedatolisib + Palbociclib + Letrozole/Fulvestrant

HR+/HER2- Advanced Breast Cancer (PIK3CA Mutant)

Phase 3ActiveNCT05501886

Key Facts

Indication
HR+/HER2- Advanced Breast Cancer (PIK3CA Mutant)
Phase
Phase 3
Status
Active
Company

About Celcuity

Celcuity is a clinical-stage biotech focused on developing targeted therapies for cancers driven by the PAM pathway. Its strategic pivot from diagnostics to therapeutics is centered on the late-stage development of gedatolisib, a highly differentiated dual inhibitor. Recent Phase 3 data in HR+/HER2- advanced breast cancer suggests practice-changing potential, positioning the company for a pivotal transition to commercialization if successful.

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