Monitor initial prescription data and payer coverage decisions over the next 2-4 quarters to gauge launch trajectory. The sNDA for the PIK3CA-mutated indication, if approved, would roughly double the addressable patient population.
Price Chart
Executive Summary
Celcuity announced that REVTORPYK (gedatolisib) is now commercially available in the U.S. for eligible HR+/HER2- advanced breast cancer patients without a PIK3CA mutation. The drug was FDA-approved on July 14, 2026, and the company has launched a patient support program. This marks the transition from regulatory approval to actual revenue generation, a key milestone for this pre-revenue biotech.
Key Facts
- REVTORPYK (gedatolisib) is now commercially available in the U.S.
- Indicated for HR+/HER2- advanced breast cancer without a PIK3CA mutation after prior endocrine therapy.
- FDA approval was granted on July 14, 2026.
- In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet reduced risk of disease progression or death by 76% vs fulvestrant.
- A supplemental NDA was submitted in August 2026 to expand the label to include PIK3CA-mutated patients.
- Celcuity launched REVTORPYK Support Services for patient access and financial assistance.
Financial Impact
First commercial sales of REVTORPYK begin; revenue potential depends on market adoption and label expansion. No financial figures provided in the filing.
Risk Factors
- Commercial adoption may be slower than expected due to competition from existing PI3K/AKT/mTOR inhibitors.
- Safety profile includes high rates of stomatitis (72% in triplet) and hyperglycemia, which may limit use.
- sNDA for PIK3CA-mutated patients is pending FDA review; rejection would cap market opportunity.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-408353 |
| Document: celc-ex99_1.htm | 0001193125-26-408353 |
| Document: 0001193125-26-408353-index-headers.html | 0001193125-26-408353 |
| Document: 0001193125-26-408353-index.html | 0001193125-26-408353 |
| Document: 0001193125-26-408353.txt | 0001193125-26-408353 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 24, 2026 3d ago | Press Release | $63.20 | awaiting T+5 | — | $67.99 (+7.58%) |
Oct 5, 2026 21d ago | 3 | $71.25 $63.19 | ▼ −11.31% | ▼ −11.17% | $67.99 (−4.58%) |
Oct 2, 2026 25d ago | 8-K | $72.10 $67.94 | ▼ −5.77% | ▼ −6.93% | $67.99 (−5.70%) |
Sep 30, 2026 27d ago | 8-K | $79.52 $65.78 | ▼ −17.28% | ▼ −19.19% | $67.99 (−14.50%) |
Sep 22, 2026 4w ago | Institutional Cluster | $84.10 $77.38 | ▼ −7.99% | ▼ −6.80% | $67.99 (−19.16%) |
Aug 26, 2026 8w ago | 8-K | $95.08 $96.20 | ▲ +1.18% | ▲ +1.30% | $67.99 (−28.49%) |
Jul 14, 2026 14w ago | 144 | $91.51 $90.14 | ▲ +1.50% | ▲ +0.52% | $67.99 (+25.70%) |
Jul 14, 2026 14w ago | Press Release | $91.51 $90.14 | ▼ −1.50% | ▼ −0.52% | $67.99 (−25.70%) |
Jun 11, 2026 19w ago | Institutional Cluster | $89.49 $88.05 | ▼ −1.61% | ▼ −2.04% | $67.99 (−24.03%) |
Jun 8, 2026 20w ago | 8-K | $92.59 $88.24 | ▼ −4.70% | ▼ −7.11% | $67.99 (−26.57%) |
US Market Status
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