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, PIK3CA wild-type, after endocrine therapy. Its next catalyst on record is gedatolisib (VIKTORIA-2 Study 1): Topline data (2028).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: gedatolisib (VIKTORIA-2 Study 1) — Topline data (2028). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| REVTORPYK (gedatolisib) - VIKTORIA-1 2L HR+/HER2- ABC, PIK3CA WT | HR+/HER2- advanced breast cancer (PIK3CA WT) | small molecule | Approved |
| gedatolisib - VIKTORIA-1 PIK3CA mutant cohort | HR+/HER2- advanced breast cancer (PIK3CA MT) | small molecule | Phase 3 |
| gedatolisib - VIKTORIA-2 (first-line, Study 1 and Study 2) | Treatment-naive HR+/HER2- advanced breast cancer | small molecule | Phase 3 |
| gedatolisib + darolutamide (CELC-G-201) | Metastatic castration-resistant prostate cancer | small molecule | Phase 2 |
| gedatolisib subcutaneous formulation | HR+/HER2- advanced breast cancer | small molecule | Pre-clinical |
Recent results and decisions
- 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 - May 1, 2026met Met primary endpoint: gedatolisib triplet gave statistically significant PFS improvement vs alpelisib plus fulvestrant; doublet also significant on secondary comparison; no numbers disclosed.
today announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib
Filing
3 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
Other phase 3 oncology companies
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- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.