Celcuity Inc.CELC
Oncology14 cited findings · profile updated 2026-08-24
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About Celcuity Inc.
Celcuity Inc. (CELC) is an oncology research site focused on developing therapies for cancer. Their drug, REVTORPYK (gedatolisib), has received approval in the United States. REVTORPYK (gedatolisib) is also recognized with a preferred Category 1 NCCN Recommendation as a second-line and/or subsequent-line therapy, and as a preferred Category 1 option.
Clinical data for gedatolisib-triplet showed an Objective Response Rate (ORR) of 49% and a Median Duration of Response (DoR) of 15.7 months. The gedatolisib-triplet also demonstrated a Median PFS of 11.1 months, compared to 5.6 months for alpelisib plus fulvestrant. For gedatolisib-doublet, the Objective Response Rate (ORR) was 36% with a Median Duration of Response (DoR) of 24.2 months. The gedatolisib-doublet achieved a Median PFS of 11.3 months, compared to 5.6 months for alpelisib plus fulvestrant. The VIKTORIA-2 trial has been expanded.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Approval | approved in United States | Celcuity Inc. — SEC 8-K (2026-08-13), p.1 |
| NCCN Recommendation | preferred Category 1 second-line and/or subsequent-line therapy for REVTORPYK (gedatolisib) | Celcuity Inc. — SEC 8-K (2026-08-13), p.2 |
| Objective Response Rate (ORR) | 49% for gedatolisib-triplet | Celcuity Inc. — SEC 8-K (2026-08-13), p.3 |
| Median Duration of Response (DoR) | 15.7 months for gedatolisib-triplet | Celcuity Inc. — SEC 8-K (2026-08-13), p.3 |
| Median PFS | 11.1 months for gedatolisib-triplet vs 5.6 months for alpelisib plus fulvestrant | Celcuity Inc. — SEC 8-K (2026-08-13), p.2 |
| Median PFS | 11.3 months for gedatolisib-doublet vs 5.6 months for alpelisib plus fulvestrant | Celcuity Inc. — SEC 8-K (2026-08-13), p.3 |
Key projects
- REVTORPYK (gedatolisib) — United States
REVTORPYK (gedatolisib) was approved in the United States.
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