Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

Rhea-AI Summary

Celcuity (NASDAQ: CELC) presented updated Phase 3 VIKTORIA-1 results for gedatolisib in HR+, HER2-, PIK3CA wild-type advanced breast cancer at SABCS on Dec 11, 2025. Key efficacy: for patients with prior therapy time-to-progression >18 months, median PFS was 12.4 months (triplet) and 10.0 months (doublet) versus 1.9 months for fulvestrant; for patients in U.S./Canada/Western Europe/Asia Pacific median PFS was 16.6 months (triplet) and 7.1 months (doublet) versus 1.9 months for fulvestrant. Patient-reported well-being deterioration was delayed (median 23.7 months triplet). Safety: stomatitis was generally manageable; no clinically relevant hyperglycemia observed.

Positive

• Median PFS 16.6 months in regional subgroup (triplet)
• Median PFS 12.4 months for prior TTP >18 months (triplet)
• Time to definitive deterioration 23.7 months (triplet)
• No clinically relevant hyperglycemia observed

Negative

• Fulvestrant control median PFS only 1.9 months
• Stomatitis required management; Grade 2–3 improvement 8–14 days

Key Figures

Median PFS >18m prior tx, triplet 12.4 months Patients with >18 months on prior therapy, gedatolisib + palbociclib + fulvestrant

Median PFS >18m prior tx, doublet 10.0 months Patients with >18 months on prior therapy, gedatolisib + fulvestrant

Median PFS control 1.9 months Fulvestrant comparator arm in highlighted subgroups

Median PFS regional, triplet 16.6 months Patients from U.S., Canada, Western Europe, Asia Pacific, triplet regimen

Median PFS regional, doublet 7.1 months Patients from U.S., Canada, Western Europe, Asia Pacific, doublet regimen

Time to QoL deterioration, triplet 23.7 months Median time to definitive deterioration vs 4.0 months for fulvestrant

HR QoL deterioration, triplet HR=0.39; p=0.0003 EQ-5D-5L well-being measures vs fulvestrant

Stomatitis improvement time 8–14 days Median time to lower grade for Grade 2/3 stomatitis across regimens

Market Reality Check

$100.77 Last Close

Volume Volume 808,760 is below the 20-day average of 989,737, suggesting no pre-news volume spike. normal

Technical Shares traded above the 200-day MA of 36.62 with a price of 101.83 ahead of this update.

Peers on Argus

Peers showed mixed, mostly modest moves (e.g., IBRX +3.14%, FOLD +0.72%, APGE -0.68%, TVTX -0.38%), while CELC was down 0.87%, pointing to a stock-specific setup rather than a sector-wide trade.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 26	SABCS preview	Positive	+0.8%	Announcement of SABCS oral presentation with updated VIKTORIA-1 subgroup data.
Nov 26	Conference appearance	Neutral	+1.3%	Scheduling of Evercore healthcare conference fireside chat and webcast access details.
Nov 17	NDA completion	Positive	-0.5%	Completion of FDA NDA submission for gedatolisib in HR+/HER2-/PIK3CA WT ABC.
Nov 12	Earnings & data	Positive	+7.6%	Q3 results plus detailed Phase 3 PIK3CA WT efficacy and development timelines.
Nov 05	Earnings scheduling	Neutral	+2.2%	Scheduling of Q3 2025 earnings release and corporate update webcast.

Pattern Detected

Positive clinical and corporate updates have mostly aligned with favorable price reactions, with one divergence on an NDA completion headline.

Recent Company History

Over recent months, Celcuity has advanced gedatolisib through Phase 3 VIKTORIA-1, reported strong PFS data, and submitted an NDA to the FDA. Clinical trial news on Jul 28 and subsequent NDA-related updates have featured substantial efficacy gains versus fulvestrant alone. Earnings and conference announcements on Nov 12 and Nov 26 coincided with moderate gains. Today’s detailed subgroup and quality-of-life results extend this sequence of data-driven milestones from the PIK3CA wild-type cohort.

Market Pulse Summary

This announcement adds detailed subgroup and quality-of-life results to prior Phase 3 VIKTORIA-1 data, highlighting extended median PFS and delayed deterioration in EQ-5D-5L scores with gedatolisib-based regimens versus fulvestrant. Historical releases show a sequence from topline efficacy to NDA submission, underlining how central this program is for Celcuity. Investors may watch for regulatory milestones, additional mutant-cohort data, and any updates on safety management such as stomatitis.

Key Terms

progression-free survival medical

"median progression-free survival (“PFS”) was 12.4 months with gedatolisib"

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.

hazard ratio medical

"median PFS was 12.4 months (HR=0.17; 95% CI: 0.11-0.28)"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

stomatitis medical

"For patients who experienced stomatitis, measures to mitigate it were generally"

Inflammation of the mouth lining, often causing soreness, ulcers, redness or swelling, like an irritating rash inside the mouth. Investors care because stomatitis can affect patient comfort and adherence in clinical trials and routine treatment, influence safety labeling, trigger additional healthcare costs or regulatory scrutiny, and therefore impact a therapy’s marketability and a healthcare company’s financial outlook.

hyperglycemia medical

"gedatolisib did not produce clinically relevant hyperglycemia and induced no dose"

Hyperglycemia is a condition where there is too much sugar in the bloodstream because the body cannot move glucose into cells effectively, like a sink with the drain partially blocked so water pools. It matters to investors because persistent high blood sugar drives demand for diabetes treatments, medical devices and hospital care, affects clinical trial outcomes and regulatory decisions, and can signal long-term cost and liability risks for healthcare companies.

EQ-5D-5L medical

"well-being measures that included mobility... (the EQ-5D-5L score)."

A standardized questionnaire that measures a patient's health across five areas — mobility, self-care, usual activities, pain/discomfort and anxiety/depression — using five levels of severity. Think of it as a concise health “report card” that converts how patients feel into a single score; investors use those scores to judge how much a treatment or product improves quality of life, informs pricing, reimbursement and market potential.

Phase 3 medical

"updated results from the randomized, Phase 3 VIKTORIA-1 trial for gedatolisib"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months for fulvestrant
  
  
• For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7.1 months with the gedatolisib doublet versus 1.9 months for fulvestrant
  
  
• Measures to mitigate stomatitis were generally effective; most patients experienced resolution to a lower grade of stomatitis within 2 weeks
  

MINNEAPOLIS, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today 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. The additional study results were presented in an oral presentation session at the 2025 San Antonio Breast Cancer Symposium (“SABCS”) today, Thursday, December 11.

Efficacy was further evaluated in several additional patient sub-groups. For patients whose time to progression on immediate prior therapy was >18 months, representing nearly half of those enrolled, median PFS was 12.4 months (HR=0.17; 95% CI: 0.11-0.28) with the gedatolisib triplet and 10.0 months (HR=0.19; 95% CI: 0.12-0.31) with the gedatolisib doublet versus 1.9 months for fulvestrant. For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, representing nearly 60% of those enrolled, median PFS was 16.6 months (HR=0.14; 95% CI: 0.09-0.26) with the gedatolisib triplet and 7.1 months (HR=0.36; 95% CI: 0.24-0.57) with the gedatolisib doublet versus 1.9 months for fulvestrant.

Additional safety analyses were also performed. For patients who experienced stomatitis, measures to mitigate it were generally effective. The median time to improvement to a lower grade of stomatitis for patients with Grade 2 or 3 stomatitis who received the gedatolisib triplet was 12 and 14 days, respectively, and for patients with Grade 2 or 3 stomatitis who received the gedatolisib doublet, the median time to improvement was 8 and 9 days, respectively. As reported previously, gedatolisib did not produce clinically relevant hyperglycemia and induced no dose reductions or withdrawals due to hyperglycemia. Consistent with these results, median glucose levels, both fasting and non-fasting, were stable over time.

Both the gedatolisib regimens delayed time to definitive deterioration versus fulvestrant according to patient reported outcomes for well-being measures that included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (the EQ-5D-5L score). The median time to definitive deterioration was 23.7 months (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003) for patients treated with the gedatolisib triplet and not reached for the gedatolisib doublet (HR=0.37; 95% CI: 0.24-0.66; p = 0.0003) versus 4.0 months for fulvestrant.

“The updated results provide further evidence of the potential for gedatolisib combined with fulvestrant with or without palbociclib to offer paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “We are very excited that patients reported nearly two years of delay in definitive deterioration of their well-being. This provides meaningful evidence of how well patients tolerated the gedatolisib regimens. This safety-profile, combined with the 16.6 months of median PFS reported for patients from the U.S., Canada, Western Europe, and Asia Pacific who received the gedatolisib triplet, further highlights the differentiated profile of the gedatolisib regimens.”

The gedatolisib clinical data being presented at the SABCS is available on the publications page of the Celcuity website.

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for 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- ABC has completed enrollment and the company has reported detailed results for the PIK3CA wild-type cohort, and has completed enrollment of patients for the PIK3CA mutant 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 currently enrolling patients. 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 clinical trial data; the ability of our data to support the filing of a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”); our expectations regarding the timing of and our ability to obtain FDA approval under the RTOR program and to commercialize 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 clinical results are based on an ongoing analysis of key efficacy and safety data and our interpretation of such data may change; unforeseen delays in the review of our NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. 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.

View source version of release on GlobeNewswire.com

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com 
Vicky Hahne, vhahne@celcuity.com 
(763) 392-0123 

ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
(415) 513-1284

FAQ

What did Celcuity announce at SABCS on December 11, 2025 for CELC?

Celcuity presented updated Phase 3 VIKTORIA-1 results showing improved median PFS with gedatolisib regimens versus fulvestrant in PIK3CA wild-type advanced breast cancer.

How long was median PFS with gedatolisib triplet in the U.S./Canada/Western Europe/Asia Pacific subgroup for CELC?

Median PFS was 16.6 months with the gedatolisib triplet in that regional subgroup.

What median PFS did CELC report for patients with prior therapy time-to-progression >18 months?

For those patients, median PFS was 12.4 months with the gedatolisib triplet and 10.0 months with the doublet.

Did Celcuity report major metabolic safety issues like hyperglycemia in VIKTORIA-1?

No; gedatolisib did not produce clinically relevant hyperglycemia and median glucose levels remained stable.

How quickly did stomatitis improve for CELC patients on gedatolisib regimens?

Median time to improvement for Grade 2–3 stomatitis ranged from 8 to 14 days depending on regimen and grade.

What does the VIKTORIA-1 data mean for CELC shareholders in the near term?

The data show clinically measurable PFS and quality-of-life improvements that could affect clinical development value and regulatory discussions.