Celcuity Stock Price, News & Analysis

Celcuity Inc. (Nasdaq: CELC) is a clinical-stage biotechnology company focused on the development of targeted therapies for oncology. According to the company’s disclosures, Celcuity is pursuing treatments for multiple solid tumor indications, with a particular emphasis on hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer and metastatic castration resistant prostate cancer. Celcuity’s work is centered on its lead therapeutic candidate, gedatolisib, an investigational, multi-target inhibitor of the PI3K/AKT/mTOR (PAM) signaling pathway. The company is headquartered in Minneapolis.

Celcuity describes gedatolisib as a potent pan-PI3K and mTORC1/2 inhibitor that is designed to comprehensively block the PAM pathway. Company materials state that its mechanism of action and pharmacokinetic properties are differentiated from currently approved and investigational therapies that target only PI3Kα, AKT, or mTORC1 alone or in combination. By targeting all four Class I PI3K isoforms as well as mTORC1 and mTORC2, gedatolisib is intended to provide broad inhibition of a key oncogenic pathway that drives tumor growth and resistance in HR+/HER2- breast cancer and other solid tumors.

Core therapeutic focus and lead program

The company identifies gedatolisib as its lead therapeutic candidate. Celcuity reports that it is developing gedatolisib primarily for patients with HR+/HER2- advanced breast cancer (ABC) whose disease has progressed following prior endocrine-based therapy, including CDK4/6 inhibitors. The company has advanced gedatolisib into multiple late- and early-stage clinical trials, with the goal of evaluating its efficacy and safety across distinct patient populations and treatment settings in solid tumors.

Celcuity highlights that gedatolisib is being evaluated in combination with fulvestrant, with or without palbociclib, in advanced breast cancer, and in combination with darolutamide in metastatic castration resistant prostate cancer (mCRPC). These combinations are designed to integrate PAM pathway inhibition with established endocrine or androgen receptor–targeted therapies and CDK4/6 inhibition, reflecting the company’s focus on targeted, mechanism-based combination regimens.

Key clinical programs and trial portfolio

Celcuity reports several active clinical trials for gedatolisib:

• VIKTORIA-1 (Phase 3): An open-label, randomized Phase 3 clinical trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease progressed on, or after, prior treatment with a CDK4/6 inhibitor and an aromatase inhibitor. The trial enrolled patients regardless of PIK3CA mutation status, with separate evaluation of PIK3CA wild-type (WT) and PIK3CA mutant (MT) cohorts. Celcuity states that enrollment in VIKTORIA-1 has been completed, that it has reported detailed results for the PIK3CA WT cohort, and that enrollment for the PIK3CA mutant cohort is complete.
• VIKTORIA-2 (Phase 3): A Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant. Celcuity reports that this study is currently enrolling patients.
• CELC-G-201 (Phase 1/2): A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer (mCRPC). Celcuity states that this trial is ongoing, with Phase 1 and Phase 1b portions designed to identify a recommended Phase 2 dose and a Phase 2 expansion to further characterize efficacy and safety.

Across these programs, Celcuity has reported that gedatolisib regimens have been generally well tolerated in clinical studies, with treatment-related adverse events (TRAEs) described as mostly low grade in the VIKTORIA-1 and prostate cancer trials. The company has disclosed detailed data on progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and safety outcomes for various patient subgroups, including PIK3CA WT and PIK3CA MT tumors, in its press releases and SEC filings.

Regulatory milestones and development status

Celcuity has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. According to the company, this NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to support more efficient review of oncology drugs. Celcuity reports that gedatolisib previously received Breakthrough Therapy and Fast Track designations from the FDA based on preliminary clinical data, and that the NDA submission is based on clinical results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial.

In addition, Celcuity has disclosed that the FDA accepted its request to submit the NDA for gedatolisib under the RTOR program and that it initiated a rolling NDA submission process. The company has described this regulatory progress as an important milestone in advancing gedatolisib toward potential availability for patients with HR+/HER2- advanced breast cancer, while noting that regulatory review and approval outcomes remain subject to FDA evaluation.

Mechanism of action and scientific rationale

Celcuity emphasizes that gedatolisib is an investigational multi-target PAM inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2. Company materials explain that inhibitors targeting only a single component of the PAM pathway, such as PI3Kα, AKT, or mTORC1, can permit adaptive cross-activation of uninhibited components, which may limit suppression of pathway activity. By contrast, Celcuity reports that gedatolisib’s comprehensive inhibition is intended to minimize this adaptive resistance and enable more complete suppression of PAM pathway signaling.

Celcuity has also noted that, in nonclinical studies and early clinical data, gedatolisib has demonstrated comparable potency and cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells. This characteristic underpins the company’s strategy of evaluating gedatolisib in both PIK3CA WT and PIK3CA MT HR+/HER2- advanced breast cancer populations within the VIKTORIA-1 trial.

Clinical data highlights disclosed by the company

In its press releases and Form 8-K filings, Celcuity has summarized several key findings from its clinical programs:

• In the VIKTORIA-1 PIK3CA wild-type cohort, Celcuity reports that the gedatolisib triplet (gedatolisib + palbociclib + fulvestrant) and the gedatolisib doublet (gedatolisib + fulvestrant) each demonstrated statistically significant and clinically meaningful improvements in median PFS compared with fulvestrant alone. The company states that the hazard ratios and incremental PFS improvements versus fulvestrant are more favorable than previously reported in Phase 3 trials for HR+/HER2- advanced breast cancer receiving at least a second line of endocrine therapy–based regimens.
• Celcuity has highlighted that gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to show positive Phase 3 results in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer whose disease progressed after CDK4/6 inhibitor treatment, based on the VIKTORIA-1 PIK3CA WT cohort.
• The company reports that in VIKTORIA-1, treatment discontinuation due to treatment-related adverse events for both the gedatolisib triplet and doublet was low, and that the regimens were generally well tolerated with mostly low-grade TRAEs. Frequently cited grade 3 TRAEs include neutropenia, stomatitis, rash, and hyperglycemia, with hyperglycemia rates described as relatively low and no clinically relevant hyperglycemia–related dose reductions or withdrawals in certain analyses.
• In the Phase 1 study of gedatolisib plus darolutamide in mCRPC, Celcuity reports a six-month radiographic PFS rate of 67% and a median radiographic PFS of 9.1 months across both dose arms, with no dose-limiting toxicities observed and no patients discontinuing treatment due to a treatment-related adverse event in the data sets described.
• Additional analyses from a Phase 1b trial in HR+/HER2- advanced breast cancer have been reported, including median PFS and ORR by PIK3CA mutation status for patients treated with gedatolisib plus palbociclib and fulvestrant, with particularly notable median PFS values in PIK3CA mutant tumors receiving the intermittent gedatolisib dosing regimen used in VIKTORIA-1.

Capital structure and financing activities

Celcuity’s SEC filings describe several financing and capital structure developments that support its clinical and potential commercial plans for gedatolisib. The company has entered into amendments to its senior secured term loan facility with lenders including Oxford Finance LLC and Innovatus Life Sciences Lending Fund I, LP, increasing the total term loan facility size and adding additional term loan tranches that may be drawn upon the achievement of specified milestones, such as FDA approval of gedatolisib in certain indications or revenue thresholds.

In addition, Celcuity has completed public offerings of common stock, pre-funded warrants, and convertible senior notes. For example, the company has disclosed an offering of 2.750% Convertible Senior Notes due 2031 and a concurrent equity offering of common stock and pre-funded warrants, with net proceeds intended for working capital and general corporate purposes, including research and development, clinical trial expenditures, and commercial launch preparations for gedatolisib. These transactions, along with warrant issuances to lenders, form part of the company’s disclosed strategy to fund its operations and late-stage development programs.

Business model and industry context

Based on its public statements, Celcuity’s business model is that of a clinical-stage oncology biotechnology company focused on discovering, developing, and advancing targeted therapies for solid tumors. The company’s current activities are centered on clinical development, regulatory interactions, and preparation for potential commercialization of gedatolisib, particularly in HR+/HER2- advanced breast cancer. Celcuity has not described commercial-stage product revenue in the provided disclosures; instead, its reported financial results emphasize research and development expenses, general and administrative costs, and financing activities that support ongoing trials and launch-readiness efforts.

Celcuity operates within the health care and social assistance sector, in the medical laboratories and biotechnology segment as characterized in the input data. Its programs are positioned at the intersection of targeted oncology, endocrine therapy, CDK4/6 inhibition, and PAM pathway modulation, with clinical collaborations that incorporate agents such as fulvestrant, palbociclib, and darolutamide.

Headquarters and listing

Celcuity states that it is headquartered in Minneapolis and that its common stock trades on Nasdaq under the ticker symbol CELC. The company’s SEC filings and press releases reference its Minneapolis, Minnesota principal executive offices and confirm its status as a Nasdaq-listed issuer.

FAQs about Celcuity Inc. (CELC)

• What does Celcuity Inc. do?
  Celcuity Inc. is a clinical-stage biotechnology company that, according to its public disclosures, is pursuing the development of targeted therapies for oncology. Its programs focus on multiple solid tumor indications, with a lead emphasis on HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
• What is gedatolisib?
  Gedatolisib is Celcuity’s lead therapeutic candidate. The company describes it as an investigational, multi-target PI3K/AKT/mTOR (PAM) inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2, with the goal of comprehensively blocking the PAM pathway in solid tumors.
• Which cancers is Celcuity targeting with gedatolisib?
  Celcuity reports that gedatolisib is being evaluated in HR+/HER2- advanced breast cancer, including both PIK3CA wild-type and PIK3CA mutant tumors, and in metastatic castration resistant prostate cancer. The company notes that it is pursuing development of targeted therapies for multiple solid tumor indications.
• What are the main clinical trials for gedatolisib?
  The company highlights three principal trials: VIKTORIA-1, a Phase 3 trial of gedatolisib plus fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer; VIKTORIA-2, a Phase 3 trial of gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer; and CELC-G-201, a Phase 1/2 trial of gedatolisib plus darolutamide in metastatic castration resistant prostate cancer.
• What regulatory steps has Celcuity taken for gedatolisib?
  Celcuity has announced completion of the submission of a New Drug Application to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. The company reports that the NDA was submitted under the FDA’s Real-Time Oncology Review program and that gedatolisib previously received Breakthrough Therapy and Fast Track designations.
• How does Celcuity describe the safety profile of gedatolisib regimens?
  In its press releases and SEC filings, Celcuity states that gedatolisib regimens in the VIKTORIA-1 trial and in the prostate cancer study were generally well tolerated, with mostly low-grade treatment-related adverse events. The company has reported low rates of treatment discontinuation due to adverse events and has highlighted the incidence of specific grade 3 events such as neutropenia, stomatitis, rash, and hyperglycemia.
• Where is Celcuity headquartered and on which exchange is it listed?
  Celcuity reports that it is headquartered in Minneapolis and that its common stock is listed on Nasdaq under the symbol CELC.
• How does Celcuity fund its clinical development programs?
  According to its SEC filings, Celcuity funds its operations through a combination of term loan facilities with lenders such as Oxford Finance LLC and Innovatus Life Sciences Lending Fund I, LP, as well as public offerings of common stock, pre-funded warrants, and convertible senior notes. The company states that proceeds are used for working capital, clinical trial expenditures, and commercial launch preparations for gedatolisib.