Celcuity Inc is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumors. Its candidate, gedatolisib, is a kinase inhibitor of the PI3K/AKT/mTOR (PAM) pathway, binding all class I PI3K isoforms and mTORC1/2, offering comprehensive inhibition with a mechanism and pharmacokinetics differentiated from other therapies. The Phase 3 VIKTORIA-1 trial, evaluating gedatolisib with fulvestrant, with or without palbociclib, in HR+/HER2- breast cancer, has completed enrollment and reported results for PIK3CA WT tumors, with cohort 2 (PIK3CA MT) also enrolled. Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials, evaluating combinations in endocrine-resistant HR+/HER2- breast cancer and metastatic castration-resistant prostate cancer, are ongoing.