Celcuity shares fall as delayed breast cancer drug launch eclipses first US FDA approval on July 16, 2026 advanced breast cancer Approved CELC Celcuity Deferred drug launch Falls gedatolisib launch Malignant neoplasm of breast Mutation PIK3CA gene Revtorpyk U.S. United States Food and Drug Administration +
Celcuity Wins FDA Approval for First-in-Class Breast Cancer Drug Revtorpyk (gedatolisib) on July 15, 2026 Approved Celcuity gedatolisib HER2-negative HR-positive Malignant neoplasm of breast mTORC1/2 inhibitor PI3 K inhibitor PIK3CA gene Revtorpyk United States Food and Drug Administration VIKTORIA-1 trial wild-type +
Celcuity's Gedatolisib Achieves Phase 3 Success in PIK3CA-Mutant Breast Cancer as FDA Decision on Wild-Type NDA Nears on May 05, 2026 Celcuity gedatolisib Malignant neoplasm of breast NDA Phase 3 PIK3CA-mutant United States Food and Drug Administration VIKTORIA-1 +
SABCS 2025 Highlights: Celcuity's Phase 3 VIKTORIA-1 Updates and Relay PI3K Inhibitor News on December 12, 2025 Celcuity gedatolisib Malignant neoplasm of breast Phase 3 PI3 K inhibitors PIK3CA gene Relay Device SABCS25 VIKTORIA-1 wild-type +