Celcuity Inc. CELC
Updated: 11 Sep 2026
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Recent News
On July 14, 2026, Celcuity received U.S. FDA approval for REVTORPYK (gedatolisib) in combination with fulvestrant for HR+/HER2- advanced breast cancer. On August 26, 2026, the company submitted a supplemental New Drug Application (sNDA) to the FDA to expand the label to PIK3CA-mutant breast cancer following positive Phase 3 VIKTORIA-1 data. Commercial shipments of the drug in the U.S. are targeted to begin in late Q3 2026.
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