Gedatolisib is a small molecule commercialized by Celcuity, with a leading Phase II program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to Globaldata, it is involved in 21 clinical trials, of which 7 were completed, 4 are ongoing, 3 are planned, and 7 were terminated. GlobalData uses proprietary data and analytics to provide a complete picture of Gedatolisib’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

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The revenue for Gedatolisib is expected to reach an annual total of $261 mn by 2035 in the US based off GlobalData’s Expiry Model. The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Gedatolisib Overview

Gedatolisib (PF-05212384, PKI-587) is under development for ER+/HER2-negative metastatic breast cancer, HER-2 positive breast cancer and triple-negative breast cancer, head and neck cancer squamous cell carcinoma, small-cell lung cancer, pancreatic cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, gynaecological cancer, solid tumor. It is administered as intravenous infusion. The drug candidate acts by targeting dual PI3K/mTOR. It was also under development for endometrial cancer as second and third line therapy, metastatic colorectal cancer, glioblastoma, renal cancer and pancreatic ductal adenocarcinoma.

It was under development for the treatment of relapsed refractory acute myeloid leukemia and myelodysplastic syndrome, non-small cell lung cancer, squamous small cell lung carcinoma, endometrial cancer, ovarian cancer, cervical cancer, metastatic breast cancer, metastaic ovarian cancer, esophagal-gastric cancer, head and neck cancer squamous cell carcinoma and hormone refractory (castration resistant, androgen-independent) prostate cancer, transitional cell cancer (urothelial cell cancer), oropharyngeal cancer, ovarian cancer and pancreatic cancer.

Celcuity Overview

Celcuity is a cellular analysis company. It develops companion diagnostic tests to identify new patient populations for targeted therapies. The company’s CELx signaling function diagnostic platform utilizes a patient’s living tumor cells to identify the specific abnormal cellular activity. It also develops CELx multi-pathway (MP) signaling function test for breast cancer which measures HER1, HER2, HER3, and c-Met signaling activity in a patient’s live tumor cells. The company partners with pharmaceutical companies to evaluate the efficacy of targeted therapies in patients diagnosed with cancer. Celcuity is headquartered in Minneapolis, Minnesota, the US.
The operating loss of the company was US$39.4 million in FY2022, compared to an operating loss of US$28.4 million in FY2021. The net loss of the company was US$40.4 million in FY2022, compared to a net loss of US$29.6 million in FY2021.

For a complete picture of Gedatolisib’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.

This content was updated on 18 March 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, drug margins and company expenses. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate valuation, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA) and phase transition success rate (PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.