Celcuity Inc.
celcuity.comWhat Do They Do?
Develops gedatolisib, a targeted cancer medicine for patients with breast and prostate cancers.
10-K for FY2025, filed Mar 26, 2026We are a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor…View ↗
How Do They Make Money?
No revenue reported yet.
10-K for FY2025, filed Mar 26, 2026
How Are They Changing?
- Net income
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Sources
10-Q for Q2 FY2026, filed Aug 13, 2026
−$78.9MView ↗
- ▲ +74% (Loss)
- vs −$45.3M in Q2 FY2025
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Aug 26, 2026
Celcuity submits an application for REVTORPYK in PIK3CA-mutant breast cancer
The application seeks use in locally advanced or metastatic breast cancer with a PIK3CA mutation after endocrine therapy.
Sources
8-K, filed Aug 26, 2026
On August 26, 2026, Celcuity Inc. (the "Company") issued a press release announcing the submission of its supplemental New Drug Application…View ↗
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Jul 15, 2026
FDA approves REVTORPYK for PIK3CA wild-type advanced breast cancer
The approval covers locally advanced or metastatic disease after progression on endocrine therapy.
Sources
8-K, filed Jul 15, 2026
On July 14, 2026, Celcuity Inc. (the “Company”) issued a press release announcing U.S. Food and Drug Administration (“FDA”) approval of…View ↗
Diagnostics to drug development
The older report paired gedatolisib development with CELsignia, a live-cell tumor diagnostic platform; the latest business description focuses on developing gedatolisib for solid tumor treatments.
10-K for FY2022, filed Mar 23, 2023 10-K for FY2025, filed Mar 26, 2026We are a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor…View ↗
Broader cancer focus
The older report described the initial clinical program as focused on advanced breast cancer; the latest report also describes a gedatolisib trial for metastatic prostate cancer.
10-K for FY2022, filed Mar 23, 2023 10-K for FY2025, filed Mar 26, 2026Our therapeutic candidate, gedatolisib, is a potent, well-tolerated, small molecule dual inhibitor, administered intravenously, that…View ↗
We are a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor…View ↗
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