Celcuity Inc. CELC
Celcuity Inc. (Nasdaq: CELC) is an oncology drug developer. Its lead program, REVTORPYK (gedatolisib), is in Phase 3 for HR+/HER2- advanced breast cancer. Its next catalyst on record is REVTORPYK (gedatolisib): Further updates from PIK3CA WT and MT cohorts of VIKTORIA-1 at San Antonio Breast Cancer Symposium (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: REVTORPYK (gedatolisib) — Further updates from PIK3CA WT and MT cohorts of VIKTORIA-1 at San Antonio Breast Cancer Symposium (2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| REVTORPYK (gedatolisib) | HR+/HER2- ABC without PIK3CA mutation (second-line) | small molecule | Approved |
| gedatolisib (sNDA) | HR+/HER2- ABC with PIK3CA mutation (second-line) | small molecule | Phase 3 |
| gedatolisib (VIKTORIA-2 Study 1) | endocrine-resistant HR+/HER2- ABC (first-line) | small molecule | Phase 3 |
| gedatolisib (VIKTORIA-2 Study 2) | endocrine-sensitive HR+/HER2- ABC (first-line) | small molecule | Phase 3 |
| gedatolisib + darolutamide (CELC-G-201) | metastatic castration-resistant prostate cancer | small molecule | Phase 2 |
| gedatolisib subcutaneous formulation | various (development for future indications) | small molecule | Pre-clinical |
Recent results and decisions
- Nov 5, 2026positive Updated Phase 1b/2 data showed median rPFS of 15.7 months in patients with prior abiraterone exposure and 9.1 months with prior enzalutamide exposure.
Median radiographic progression free survival ("rPFS") was 15.7 months and the six-month rPFS rate ("rPFS6") was 82.2% in patients with prior exposure to abiraterone. Median rPFS was 9.1 months and rPFS6 was 62.5% in patients with prior exposure to enzalutamide.
Filing - Aug 26, 2026submitted Celcuity submitted an sNDA to FDA for REVTORPYK in PIK3CA mutant HR+/HER2- advanced breast cancer (triplet HR 0.50, median PFS 11.1 vs 5.6 months vs alpelisib plus fulvestrant).
The application to the FDA is supported by positive results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial.
Filing - Jul 14, 2026approval FDA approved REVTORPYK (gedatolisib) with fulvestrant, with or without palbociclib, for PIK3CA wild-type HR+/HER2- advanced breast cancer after endocrine therapy (triplet PFS 9.3 vs 2.0 months, HR 0.24).
REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.