The sNDA submission is a major catalyst that could double REVTORPYK's addressable market. Traders should monitor for FDA acceptance of the filing and a PDUFA date, as well as any updates on the ongoing VIKTORIA-2 first-line trial. The stock has a strong historical win rate (60% at T+20) on prior reports, supporting a bullish read on this pipeline-expanding event.
Price Chart
Executive Summary
Celcuity submitted a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK (gedatolisib) to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation. This follows the drug's recent FDA approval on July 14, 2026, for the PIK3CA wild-type population. The sNDA is supported by Phase 3 VIKTORIA-1 data showing a 50% reduction in the risk of disease progression or death versus alpelisib, potentially doubling the drug's addressable patient population.
Key Facts
- Celcuity submitted an sNDA to the FDA for REVTORPYK (gedatolisib) for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
- The sNDA is supported by the Phase 3 VIKTORIA-1 trial, which showed the REVTORPYK-triplet reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; p<0.0001).
- Median progression-free survival (PFS) was 11.1 months with the REVTORPYK-triplet vs. 5.6 months with alpelisib plus fulvestrant.
- REVTORPYK was already approved by the FDA on July 14, 2026, for the PIK3CA wild-type population, and this sNDA seeks to expand the label to include PIK3CA mutant patients.
- Approximately 40% of HR+/HER2- breast cancers have PIK3CA mutations, potentially doubling the drug's addressable patient population.
Financial Impact
Expanding the addressable patient population by approximately 40% (PIK3CA mutant share of HR+/HER2- breast cancer) could significantly increase peak revenue potential for REVTORPYK.
Risk Factors
- FDA may issue a Complete Response Letter (CRL) or require additional data before approval.
- Competition from other PI3K inhibitors (e.g., alpelisib, inavolisib) could limit market share.
- Commercial launch execution risks for a drug recently approved in a narrower indication.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 3 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-365975 |
| Document: 0001193125-26-365975-index.html | 0001193125-26-365975 |
| Document: 0001193125-26-365975.txt | 0001193125-26-365975 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 26, 2026 5w ago | 8-K | $95.08 $84.00 | ▼ −11.65% | ▼ −12.86% | $72.69 (−23.55%) |
Jul 15, 2026 11w ago | 144 | $91.51 $92.08 | ▼ −0.62% | ▲ +1.72% | $72.69 (+20.57%) |
Jul 14, 2026 11w ago | Press Release | $91.51 $92.08 | ▲ +0.62% | ▼ −1.72% | $72.69 (−20.57%) |
Jun 11, 2026 16w ago | Institutional Cluster | $89.49 $113.51 | ▲ +26.84% | ▲ +24.95% | $72.69 (−18.77%) |
Jun 8, 2026 16w ago | 8-K | $92.59 $115.72 | ▲ +24.98% | ▲ +23.53% | $72.69 (−21.49%) |
Jun 5, 2026 17w ago | 424B5 | $88.28 $108.58 | ▲ +23.00% | ▲ +21.13% | $72.69 (−17.66%) |
Jun 4, 2026 17w ago | Press Release | $92.47 $107.95 | ▲ +16.74% | ▲ +18.11% | $72.69 (−21.39%) |
Jun 3, 2026 17w ago | Press Release | $88.95 $107.95 | ▼ −21.36% | ▼ −22.36% | $72.69 (+18.28%) |
Jun 3, 2026 17w ago | 424B5 | $88.95 $107.95 | ▼ −21.36% | ▼ −22.36% | $72.69 (+18.28%) |
Jun 2, 2026 17w ago | 8-K | $91.42 $104.49 | ▲ +14.30% | ▲ +15.86% | $72.69 (−20.49%) |
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