Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology

Rhea-AI Summary

Celcuity (NASDAQ: CELC) announced publication of Phase 3 VIKTORIA-1 PIK3CA wild-type cohort results in Journal of Clinical Oncology on March 9, 2026.

The gedatolisib triplet (gedatolisib+palbociclib+fulvestrant) showed median PFS 9.3 vs 2.0 months (HR=0.24; p<0.0001) and ORR 31.5%. The doublet showed median PFS 7.4 vs 2.0 months (HR=0.33; p<0.0001) and ORR 28.3%. FDA granted Priority Review with a PDUFA goal date of July 17, 2026.

Positive

• PFS +7.3 months with gedatolisib triplet versus fulvestrant
• PFS +5.4 months with gedatolisib doublet versus fulvestrant
• Objective response rate 31.5% for gedatolisib triplet
• Objective response rate 28.3% for gedatolisib doublet
• FDA Priority Review assigned; PDUFA date July 17, 2026

Negative

• Grade 3 neutropenia in 52.3% of gedatolisib triplet patients
• Grade 4 neutropenia in 10.0% of gedatolisib triplet patients
• Grade 3 stomatitis in 19.2% of gedatolisib triplet patients
• Treatment discontinuation due to TRAEs: 2.3% triplet, 3.1% doublet

Key Figures

Risk reduction (triplet): 76% reduction in risk of progression or death Risk reduction (doublet): 67% reduction in risk of progression or death Median PFS (triplet): 9.3 months vs 2.0 months +5 more

8 metrics

Risk reduction (triplet) 76% reduction in risk of progression or death Gedatolisib + palbociclib + fulvestrant vs fulvestrant in PIK3CA WT cohort

Risk reduction (doublet) 67% reduction in risk of progression or death Gedatolisib + fulvestrant vs fulvestrant in PIK3CA WT cohort

Median PFS (triplet) 9.3 months vs 2.0 months Phase 3 VIKTORIA-1 PIK3CA WT cohort

Median PFS (doublet) 7.4 months vs 2.0 months Phase 3 VIKTORIA-1 PIK3CA WT cohort

ORR (triplet vs control) 31.5% vs 1% Objective response rate in PIK3CA WT cohort

ORR (doublet) 28.3% Objective response rate for gedatolisib + fulvestrant

Median DOR 17.5 vs 12.0 months Duration of response for triplet vs doublet regimens

PDUFA goal date July 17, 2026 FDA Priority Review of gedatolisib NDA

Market Reality Check

Price: $115.16 Vol: Volume 962,902 is 56% abo...

high vol

$115.16 Last Close

Volume Volume 962,902 is 56% above the 20-day average of 616,148 shares. high

Technical Shares at $113.45 are trading above the 200-day MA of $65.06, near the -5.71% mark vs 52-week high.

Peers on Argus

CELC was down 1.35% pre-news while key biotech peers were mixed, with names like...

CELC was down 1.35% pre-news while key biotech peers were mixed, with names like TVTX up 6.47% and CGON slightly negative, indicating stock-specific dynamics rather than a coordinated sector move.

Common Catalyst Select peers such as IBRX also had oncology regulatory news, but overall moves were not uniformly aligned with CELC.

Previous Clinical trial Reports

5 past events · Latest: Jan 20 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 20	NDA acceptance	Positive	-1.5%	FDA accepted gedatolisib NDA with Priority Review and RTOR designation.
Dec 11	SABCS data update	Positive	-1.0%	Updated VIKTORIA-1 cohort results with strong PFS and well-being outcomes at SABCS.
Nov 26	SABCS presentation notice	Positive	+0.8%	Announcement of accepted oral presentation on updated VIKTORIA-1 data at SABCS.
Nov 17	NDA submission	Positive	-0.7%	Completion of gedatolisib NDA submission under FDA RTOR using Phase 3 data.
Oct 18	ESMO detailed results	Positive	+35.8%	Detailed VIKTORIA-1 Phase 3 results at ESMO showing improved PFS and ORR.

Pattern Detected

Clinical VIKTORIA-1 updates and regulatory milestones have generally been positive but produced mixed price reactions, including several small declines and one large spike on detailed Phase 3 data.

Recent Company History

Over the past few months, Celcuity has repeatedly highlighted Phase 3 VIKTORIA-1 data for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. Detailed results at ESMO 2025 on Oct 18, 2025 and updates ahead of SABCS in Nov–Dec 2025 showed strong PFS and response metrics. These data supported completion of the NDA on Nov 17, 2025 and FDA acceptance with Priority Review and a July 17, 2026 PDUFA date announced on Jan 20, 2026. Today’s JCO publication reflects peer-reviewed confirmation of efficacy and safety already central to prior milestones.

Historical Comparison

+6.7% avg move · Across five recent clinical-trial-related announcements, CELC saw an average move of 6.69%, with rea...

clinical trial

+6.7%

Average Historical Move clinical trial

Across five recent clinical-trial-related announcements, CELC saw an average move of 6.69%, with reactions ranging from modest declines to a sharp gain on detailed VIKTORIA-1 data.

Clinical-trial news has traced a clear path: initial detailed VIKTORIA-1 results at ESMO 2025, further subgroup data and presentations at SABCS, completion and then FDA acceptance of the NDA, and now publication of pivotal cohort results in a top oncology journal.

Regulatory & Risk Context

Active S-3 Shelf · $400,000,000

Shelf Active

Active S-3 Shelf Registration 2026-01-09

$400,000,000 registered capacity

An effective S-3ASR automatic shelf filed on Jan 9, 2026 allows Celcuity to issue up to $400,000,000 of common stock via an at-the-market program with Jefferies and to offer additional unspecified securities, providing flexibility to raise capital for gedatolisib clinical and commercial activities.

Market Pulse Summary

This announcement highlights robust Phase 3 VIKTORIA-1 results in PIK3CA wild-type HR+/HER2- advance...

Analysis

This announcement highlights robust Phase 3 VIKTORIA-1 results in PIK3CA wild-type HR+/HER2- advanced breast cancer, with median PFS of 9.3 vs 2.0 months for the triplet and ORR of 31.5% vs 1%. The data underpin an NDA under Priority Review with a July 17, 2026 PDUFA date and now appear in a leading oncology journal. Investors may watch for regulatory decisions, real-world tolerability, and how Celcuity uses its $400,000,000 ATM capacity to support commercialization.

Key Terms

pi3k/akt/mtor, progression-free survival, objective response rate, duration of response, +4 more

8 terms

pi3k/akt/mtor medical

"gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor"

A cellular signaling pathway made of proteins called PI3K, AKT and mTOR that helps control cell growth, survival and metabolism; think of it as a central control system that tells cells when to divide, store energy or self-repair. It matters to investors because drugs or diagnostics that affect this pathway are key targets in cancer and other diseases, so progress, trial results or regulatory changes around these targets can strongly influence a biotech or pharmaceutical company’s value.

progression-free survival medical

"first Phase 3 study to show a significant improvement in median progression-free survival"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

objective response rate medical

"The objective response rate (“ORR”) of the gedatolisib triplet was 31.5%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

duration of response medical

"the median duration of response (“DOR”) was 17.5 months"

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

treatment-related adverse events medical

"mostly low-grade treatment-related adverse events (“TRAEs”). The most common grade 3 TRAEs"

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

cdk4/6 inhibitor medical

"following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor"

A CDK4/6 inhibitor is a type of cancer drug that blocks two proteins (CDK4 and CDK6) that tell cells to divide, effectively slowing or stopping the growth of tumors. Think of it as cutting power to a photocopier that keeps making cancer cells; that control can shrink tumors or delay progression. For investors, these drugs matter because clinical trial results, regulatory approvals, patent life, safety issues and competition directly affect sales potential and company value.

new drug application regulatory

"Priority Review of Celcuity’s New Drug Application for gedatolisib"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

prescription drug user fee act regulatory

"assigned a Prescription Drug User Fee Act goal date of July 17, 2026"

A federal program that lets drug makers pay fees to the U.S. regulator to fund and speed up the review of new medicines and label changes. Investors care because it affects how quickly a drug can move from testing to market and how predictable approval timelines and regulatory interactions are — like buying a faster lane at a busy checkpoint that can reduce uncertainty about a product’s commercial timing.

AI-generated analysis. Not financial advice.

• As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the risk of disease progression or death versus fulvestrant by 76% and 67%, respectively
  

MINNEAPOLIS, March 09, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today 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. The cohort consists of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) PIK3CA WT advanced breast cancer (“ABC”), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

The publication is titled “VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer.”

“VIKTORIA-1 is the first Phase 3 study to show a significant improvement in median progression-free survival with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type HR+/HER2- advanced breast cancer who previously received a CDK4/6 inhibitor,” said Sara Hurvitz, MD, lead study author and Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine.

In the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 trial, median progression-free survival (“PFS”) with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate (“ORR”) of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response (“DOR”) was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.

The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events (“TRAEs”). The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group), and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.

“The efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort represent an important addition to the clinical evidence in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “Importantly, these findings are potentially practice changing for patients with limited options.”

The U.S. Food and Drug Administration has granted Priority Review of Celcuity’s New Drug Application for gedatolisib and assigned a Prescription Drug User Fee Act goal date of July 17, 2026.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.³ Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.^4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.⁸ Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and did not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed PI3KCA mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.^9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.¹¹ Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.^11,12

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer (“ABC”), has completed enrollment, and the company has reported detailed results for the PIK3CA wild-type cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is ongoing. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the status and timing of the FDA’s review of our New Drug Application for gedatolisib; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials or the FDA’s review of our NDA for gedatolisib; and unanticipated developments that may impact the design of our clinical trials. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References:

1. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today, accessed 09 March 2026.
   
   
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025). 
   https://seer.cancer.gov/statfacts/html/breast-subtypes.html
   
   
3. Alves, C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J Mol Sci, 2023;24(5),4522. https://doi.org/10.3390/ijms24054522
   
   
4. United States Package Insert, US FDA, ITOVEBI
   
   
5. United States Package Insert, US FDA, PIQRAY
   
   
6. United States Package Insert, US FDA, TRUCAP
   
   
7. United States Package Insert, US FDA, AFINITOR
   
   
8. Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30
   
   
9. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p
   
   
10. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694
    
    
11. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0
    
    
12. Layman, R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487. https://doi.org/10.1016/S1470-2045(24)00034-2

Contacts:

For investors:
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For media:
Sam Brown LLC
Mike Beyer, mikebeyer@sambrown.com
(312) 961-2502

FAQ

What were the VIKTORIA-1 PIK3CA wild-type results for CELC on March 9, 2026?

The gedatolisib triplet showed median PFS 9.3 months versus 2.0 months. According to Celcuity, the triplet had HR=0.24 (p<0.0001) and ORR 31.5%, while the doublet showed median PFS 7.4 months and ORR 28.3%.

How did gedatolisib triplet (CELC) perform versus fulvestrant in PFS and ORR?

Gedatolisib triplet improved median PFS by 7.3 months versus fulvestrant. According to Celcuity, median PFS was 9.3 vs 2.0 months, ORR 31.5%, and median DOR 17.5 months.

What safety issues were reported for gedatolisib regimens in the VIKTORIA-1 PIK3CA WT cohort?

The regimens were generally tolerable but had notable hematologic events. According to Celcuity, grade 3 neutropenia occurred in 52.3% (triplet) and grade 4 neutropenia in 10.0% (triplet); stomatitis and hyperglycemia were also reported.

Does Celcuity (CELC) have regulatory progress after the VIKTORIA-1 publication?

Yes, the FDA granted Priority Review with a PDUFA goal date of July 17, 2026. According to Celcuity, the New Drug Application for gedatolisib received this assignment.

What is the median duration of response (DOR) reported for CELC's gedatolisib treatments?

Median DOR was 17.5 months for the gedatolisib triplet and 12.0 months for the doublet. According to Celcuity, fulvestrant had only one response, so median DOR was not determinable.