Monitor for potential label expansion into PIK3CA mutant population and any updates on VIKTORIA-2 first-line trial. The data supports gedatolisib's differentiation but the stock's prior approval is already priced in; watch for commercial adoption metrics in upcoming quarters.
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Executive Summary
Celcuity presented new subgroup analyses from the Phase 3 VIKTORIA-1 study at ESMO 2026, showing gedatolisib triplet significantly improved median PFS (21.5 months) vs alpelisib + fulvestrant (9.1 months) in PIK3CA-mutant HR+/HER2- advanced breast cancer patients without liver metastases. The data also showed superior ORR (59% vs 33%) and duration of response (19.4 vs 7.5 months) with lower discontinuation rates (5% vs 19%). These results strengthen the clinical profile of REVTORPYK (gedatolisib) but the stock has already been approved and the data is incremental, not transformative.
Key Facts
- Gedatolisib triplet showed median PFS of 21.5 months vs 9.1 months for alpelisib + fulvestrant in patients without liver metastases (HR 0.46, p=0.0016)
- ORR was 59% for gedatolisib triplet vs 33% for alpelisib + fulvestrant in PIK3CA mutant cohort
- Median duration of response was 19.4 months for gedatolisib triplet vs 7.5 months for alpelisib + fulvestrant
- Discontinuation rate due to TEAEs was 5% for gedatolisib triplet vs 19% for alpelisib
- Network meta-analysis showed gedatolisib triplet/doublet statistically significant 2x and 1.5x more likely to survive without progression vs imlunestrant + abemaciclib
Financial Impact
Positive read-through for REVTORPYK commercial prospects; strengthens competitive positioning against alpelisib and imlunestrant regimens in HR+/HER2- advanced breast cancer
Risk Factors
- Competitive landscape includes alpelisib, imlunestrant, and other PI3K/AKT/mTOR pathway inhibitors
- VIKTORIA-1 data is subgroup analysis, not a new registration study
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3387663 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 24, 2026 3d ago | Press Release | $63.20 | awaiting T+5 | — | $68.57 (+8.50%) |
Oct 5, 2026 21d ago | 3 | $71.25 $63.19 | ▼ −11.31% | ▼ −11.17% | $68.57 (−3.75%) |
Oct 2, 2026 25d ago | 8-K | $72.10 $67.94 | ▼ −5.77% | ▼ −6.93% | $68.57 (−4.89%) |
Sep 30, 2026 27d ago | 8-K | $79.52 $65.78 | ▼ −17.28% | ▼ −19.19% | $68.57 (−13.76%) |
Sep 22, 2026 5w ago | Institutional Cluster | $84.10 $77.38 | ▼ −7.99% | ▼ −6.80% | $68.57 (−18.46%) |
Aug 26, 2026 8w ago | 8-K | $95.08 $96.20 | ▲ +1.18% | ▲ +1.30% | $68.57 (−27.88%) |
Jul 14, 2026 14w ago | 144 | $91.51 $90.14 | ▲ +1.50% | ▲ +0.52% | $68.57 (+25.06%) |
Jul 14, 2026 14w ago | Press Release | $91.51 $90.14 | ▼ −1.50% | ▼ −0.52% | $68.57 (−25.06%) |
Jun 11, 2026 19w ago | Institutional Cluster | $89.49 $88.05 | ▼ −1.61% | ▼ −2.04% | $68.57 (−23.37%) |
Jun 8, 2026 20w ago | 8-K | $92.59 $88.24 | ▼ −4.70% | ▼ −7.11% | $68.57 (−25.94%) |
US Market Status
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