This section highlights FDA-related milestones and regulatory updates for drugs developed by Celcuity (CELC).
Over the past two years, Celcuity has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Gedatolisib and VIKTORIA-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Gedatolisib FDA Regulatory Timeline and Events
Gedatolisib is a drug developed by Celcuity for the following indication: HR+ / HER2- Metastatic Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Gedatolisib
- Announced Date:
- May 14, 2026
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced updates to the Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-") locally advanced or metastatic breast cancer ("ABC").
AI Summary
Celcuity Inc. announced updated plans for its Phase 3 VIKTORIA-2 trial of gedatolisib, a first-line treatment for people with HR+/HER2- locally advanced or metastatic breast cancer. The revised study is being split into two parts to better match patients by endocrine sensitivity. Study 1 will enroll about 440 patients whose cancer became resistant during or soon after adjuvant endocrine therapy. It will compare gedatolisib plus palbociclib and fulvestrant with ribociclib plus fulvestrant.
Study 2 will enroll about 740 patients whose cancer is endocrine-sensitive or de novo metastatic. It will compare gedatolisib plus palbociclib and letrozole with ribociclib plus letrozole. The main goal in both studies is progression-free survival, measured by blinded independent review. The global trial may run at up to 200 sites across North America, Europe, and Asia-Pacific. Celcuity said the new design is meant to better support future development of gedatolisib, including a possible subcutaneous version for longer treatment use.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- May 1, 2026
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA mutant locally advanced or metastatic breast cancer ("ABC"), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
AI Summary
Celcuity announced positive topline results from the PIK3CA-mutant cohort of the Phase 3 VIKTORIA-1 trial. The study evaluated gedatolisib plus fulvestrant, with or without palbociclib, in patients with hormone receptor–positive, HER2‑negative, PIK3CA‑mutant locally advanced or metastatic breast cancer who progressed on or after a CDK4/6 inhibitor and an aromatase inhibitor. The company said the findings support its approach to targeting the PI3K/AKT/mTOR pathway and suggested the results could have implications beyond this second‑line setting.
Celcuity intends to submit these PIK3CA‑mutant data to the U.S. Food and Drug Administration as a supplemental New Drug Application (sNDA) and to pursue submissions with other regulatory authorities after the sNDA filing. The company also plans further development efforts to explore gedatolisib in additional patient groups whose cancers involve the same pathway.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- March 9, 2026
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced publication of efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in the Journal of Clinical Oncology.
AI Summary
Celcuity Inc. announced publication in the Journal of Clinical Oncology of efficacy and safety results from the PIK3CA wild-type (WT) cohort of the Phase 3 VIKTORIA-1 trial. The cohort enrolled patients with hormone receptor–positive (HR+), HER2‑negative advanced breast cancer whose disease progressed on or after a CDK4/6 inhibitor and an aromatase inhibitor. Gedatolisib is an investigational pan‑PI3K/mTORC1/2 inhibitor being studied in this setting.
As previously presented, the gedatolisib triplet (gedatolisib + palbociclib + fulvestrant) and the gedatolisib doublet (gedatolisib + fulvestrant) reduced the risk of disease progression or death versus fulvestrant alone by 76% and 67%, respectively. The published paper reports both the efficacy and safety findings, and Celcuity states these results could be practice changing for patients with limited treatment options. The JCO publication adds peer‑reviewed support to the company’s clinical data.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- January 20, 2026
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced that the U.S. Food and Drug Administration ("FDA") has accepted for filing its New Drug Application ("NDA") for gedatolisib in hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA wild-type advanced breast cancer ("ABC").
AI Summary
Celcuity announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application (NDA) for gedatolisib to treat hormone receptor–positive (HR+), HER2‑negative, PIK3CA wild‑type advanced breast cancer. The FDA granted Priority Review and set a PDUFA goal date of July 17, 2026. The NDA was submitted under the FDA’s Real‑Time Oncology Review (RTOR) program to help speed the review, and the application is based on clinical data from the PIK3CA wild‑type cohort of the Phase 3 VIKTORIA‑1 trial.
Gedatolisib is an investigational drug that blocks multiple nodes in the PI3K/AKT/mTOR (PAM) pathway. Celcuity says this broader inhibition may reduce adaptive pathway activation and showed activity in preclinical and early clinical studies. The company views the FDA’s acceptance and assigned review timeline as an important step toward making a new treatment option available for these patients and plans to work with the agency during the review.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- December 11, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc announced updated results from the randomized, Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR ("PAM") inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA wild-type ("WT"), advanced breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
AI Summary
Celcuity reported updated Phase 3 VIKTORIA-1 results for gedatolisib, a multi‑target PI3K/AKT/mTOR (PAM) inhibitor, in adults with HR+, HER2‑, PIK3CA wild‑type advanced breast cancer after progression on a CDK4/6 inhibitor and an aromatase inhibitor.
In patients whose time to progression on immediate prior therapy was >18 months (nearly half of enrollees), median progression‑free survival (PFS) was 12.4 months with gedatolisib+palbociclib+fulvestrant (triplet) and 10.0 months with gedatolisib+fulvestrant (doublet) versus 1.9 months for fulvestrant. For patients enrolled in the U.S., Canada, Western Europe and Asia Pacific (about 60%), median PFS was 16.6 months (triplet) and 7.1 months (doublet) versus 1.9 months for fulvestrant.
Safety analyses showed stomatitis was generally manageable: median time to improvement for Grade 2 and 3 stomatitis was 12 and 14 days with the triplet and 8 and 9 days with the doublet. Gedatolisib did not cause clinically relevant hyperglycemia, and median fasting and non‑fasting glucose levels remained stable.
Patient‑reported outcomes also favored the gedatolisib regimens: time to definitive deterioration was 23.7 months with the triplet and was not reached with the doublet, versus 4.0 months for fulvestrant.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- November 17, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc announced the completion of the submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for gedatolisib in hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), advanced breast cancer ("ABC").
AI Summary
Celcuity Inc. announced it completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for gedatolisib to treat hormone receptor–positive (HR+), HER2‑negative advanced breast cancer.
The NDA is based on data from the PIK3CA wild‑type cohort of the Phase 3 VIKTORIA‑1 trial. In that group, the gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) cut the risk of progression or death by 76% versus fulvestrant alone (hazard ratio 0.24). Median progression‑free survival (PFS) was 9.3 months versus 2.0 months, an improvement of 7.3 months. The gedatolisib doublet (gedatolisib and fulvestrant) reduced risk by 67% (HR 0.33) with median PFS of 7.4 months versus 2.0 months, an improvement of 5.4 months.
Gedatolisib is an investigational drug that targets multiple nodes of the PI3K/AKT/mTOR pathway. Celcuity says these trial results support the NDA and the company will engage with the FDA during the review process.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- October 18, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant ("MT") tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
AI Summary
Celcuity Inc said its Phase 3 VIKTORIA-1 trial’s PIK3CA mutant cohort is now 100% enrolled. This study compares gedatolisib plus fulvestrant, with or without palbociclib, against alpelisib plus fulvestrant in adults with HR-positive, HER2-negative, PIK3CA-mutant advanced breast cancer after a CDK4/6 inhibitor and an aromatase inhibitor. The company expects to report topline data in late Q1 or Q2 2026.
Data from a Phase 1b trial showed that patients with PIK3CA-mutant tumors (n=30) treated with gedatolisib, fulvestrant, and palbociclib had a median progression-free survival (PFS) of 14.6 months and an objective response rate (ORR) of 48%. Among those on the intermittent gedatolisib schedule used in VIKTORIA-1, median PFS was 19.7 months and ORR was 64%. Celcuity’s Chief Medical Officer described these results as promising ahead of Phase 3 results.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- July 28, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
AI Summary
Celcuity reported top results from the PIK3CA wild-type group of its Phase 3 VIKTORIA-1 trial. The study tested gedatolisib plus fulvestrant, with or without palbociclib, against fulvestrant alone in HR+/HER2- advanced breast cancer after progression on CDK4/6 and aromatase inhibitor therapy.
The gedatolisib triplet cut the risk of disease progression or death by 76% versus fulvestrant (hazard ratio 0.24; p<0.0001), boosting median progression-free survival to 9.3 months versus 2.0. The gedatolisib doublet lowered risk by 67% (HR 0.33; p<0.0001), raising median PFS to 7.4 months.
Both gedatolisib regimens showed good safety, with fewer treatment-related dropouts and lower rates of hyperglycemia and stomatitis than seen in earlier studies or approved regimens.
Celcuity will present full wild-type results at a medical conference later this year. It aims to file an NDA for gedatolisib in Q4 2025 and expects mutation-cohort data by the end of that year.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- July 28, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc reported topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, which evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant.
AI Summary
Celcuity Inc. reported positive topline results from the PIK3CA wild-type group of the Phase 3 VIKTORIA-1 trial, which tested gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant alone in HR-positive, HER2-negative advanced breast cancer. The gedatolisib triplet cut progression or death risk by 76% (HR=0.24; p<0.0001), extending median progression-free survival (PFS) to 9.3 months versus 2.0 months. The gedatolisib doublet reduced risk by 67% (HR=0.33; p<0.0001), with median PFS of 7.4 months versus 2.0 months.
These hazard ratios and PFS gains are unprecedented in this setting. Both gedatolisib regimens were well tolerated, with fewer treatment-related discontinuations and lower rates of hyperglycemia and stomatitis than seen in prior studies of approved drug combinations for similar patients.
Celcuity will present full data at a medical conference later this year and expects to file a New Drug Application in the U.S. in the fourth quarter of 2025. Topline results for the PIK3CA mutation cohort are anticipated by the end of 2025.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- July 24, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc announced that the first patient has been dosed in VIKTORIA-2, its 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 ("ABC") who are endocrine therapy resistant.
AI Summary
Celcuity Inc. has dosed the first patient in VIKTORIA-2, its Phase 3 trial testing gedatolisib with a CDK4/6 inhibitor plus fulvestrant as a first-line treatment for endocrine therapy–resistant HR-positive, HER2-negative advanced breast cancer. Gedatolisib is an investigational drug that blocks multiple targets in the PI3K/AKT/mTOR pathway to stop cancer cell growth.
In an earlier Phase 1b study, patients treated with gedatolisib, palbociclib, and letrozole saw a median progression‐free survival of 48.6 months, overall survival of 77.3 months, and a 79% response rate. These results suggest that comprehensive inhibition of this pathway could help treatment‐naïve patients whose disease no longer responds to standard endocrine therapies.
VIKTORIA-2 will enroll about 638 participants worldwide, assigning them to gedatolisib plus fulvestrant and either ribociclib or palbociclib versus fulvestrant plus a CDK4/6 inhibitor. The primary goal is to measure progression‐free survival separately in tumors with and without PIK3CA mutations, aiming to bring a new first‐line option to patients.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- June 30, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that addresses all four class I PI3K isoforms and the mTOR complexes mTORC1 and mTORC2 to induce comprehensive blockade of the PI3K/AKT/mTOR ("PAM") pathway.
AI Summary
Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that blocks all four class I PI3K isoforms and both mTOR complexes, mTORC1 and mTORC2, to stop the PI3K/AKT/mTOR pathway. This comprehensive blockade is aimed at stopping cancer growth. In a Phase 1 trial for men with metastatic castration-resistant prostate cancer, combining gedatolisib with darolutamide, researchers observed a 66% six-month radiographic progression free survival rate. In a Phase 2 trial involving patients with HER2-positive metastatic breast cancer, the combination of gedatolisib with trastuzumab-pkrb led to a 43% objective response rate. Importantly, no patients stopped treatment due to side effects from gedatolisib, highlighting its good tolerability so far.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- December 11, 2024
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced overall survival (OS) data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2-advanced or metastatic breast cancer.
AI Summary
Celcuity Inc. recently announced overall survival data from a Phase 1b trial evaluating gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant for treating HR+, HER2– advanced or metastatic breast cancer. The study focused on two patient groups. One group, consisting of patients who were treatment-naïve in the advanced setting, achieved a median overall survival of 77.3 months. In contrast, patients who had previously been treated with a CDK4/6 inhibitor showed a median overall survival of 33.9 months.
According to Celcuity’s Chief Medical Officer, these findings are encouraging and compare favorably to published data for current first- and second-line treatments. The results will be presented in a poster session at the upcoming San Antonio Breast Cancer Symposium, highlighting a strategy that blocks the ER, CDK4/6, and PI3K/AKT/mTOR pathways simultaneously.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- May 30, 2024
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced that it plans to initiate a Phase 3 clinical trial to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer ("ABC") who are endocrine therapy resistant. In conjunction with its plan to conduct this study, Celcuity today entered into an amendment to an existing debt facility agreement and received an additional term loan of approximately $62 million.
AI Summary
Celcuity Inc. announced plans to launch a Phase 3 clinical trial to investigate a new first‐line treatment for patients with HR+/HER2- advanced breast cancer who are resistant to endocrine therapy. The study will test a combination of gedatolisib with fulvestrant and a CDK4/6 inhibitor, with investigators having the choice between ribociclib or palbociclib. The trial aims to compare this new treatment approach against the current standard of care, addressing a pressing need for better therapies in resistant breast cancer cases.
Alongside the trial announcement, Celcuity amended an existing debt facility agreement and secured an additional term loan of approximately $62 million. The extra financing is expected to accelerate the trial’s initiation and support the company’s continued development of targeted therapies against advanced breast cancer.
Read Announcement
VIKTORIA-1 FDA Regulatory Events
VIKTORIA-1 is a drug developed by Celcuity for the following indication: in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VIKTORIA-1
- Announced Date:
- November 26, 2025
- Indication:
- in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer
Announcement
Celcuity Inc. announced that an abstract was accepted for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) and is now available on the SABCS website.
AI Summary
Celcuity Inc. announced that an abstract has been accepted for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) and is now available on the SABCS website. The symposium runs December 9–12, 2025, and Celcuity says the presentation will include additional subgroup efficacy analyses and safety data for the study. This gives clinicians and researchers a chance to review updated results and assess how the treatment performed across different patient groups.
The abstract, from the randomized Phase 3 VIKTORIA-1 trial, is titled "Gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/PIK3CA-wild type advanced breast cancer: updated results." Author: Barbara Pistilli, MD. Presentation number RF7-04 in Rapid Fire 7 is scheduled for December 11, 2025. For details, visit the SABCS website.
Read Announcement- Drug:
- VIKTORIA-1
- Announced Date:
- September 22, 2025
- Indication:
- in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer
Announcement
Celcuity Inc. announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025.
AI Summary
Celcuity Inc., a clinical‐stage biotech company, announced that a late‐breaking abstract from its Phase 3 VIKTORIA‐1 trial will be presented orally at the European Society of Medical Oncology (ESMO) Congress, October 17–21, 2025. This selection highlights key clinical data for advanced breast cancer treatment.
The presentation will report detailed efficacy and safety results from the PIK3CA wild‐type cohort. Titled “Gedatolisib + fulvestrant ± palbociclib vs fulvestrant in patients with HR+/HER2-/PIK3CA wild‐type advanced breast cancer,” the abstract is numbered 3535.
It will appear in Proffered Paper Session 1: Breast Cancer, metastatic, on October 18, 2025, from 10:15 am to 11:45 am CEST. Late‐breaking abstracts accepted for this session will be published online on the day of the presentation.
Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor targeting the PAM pathway. VIKTORIA-1 has completed enrollment for the wild-type cohort and is now enrolling patients with PIK3CA mutations.
Read Announcement
