Celcuity to Present Updated Data 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) announced an accepted oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) covering updated results from the PIK3CA wild-type cohort of the randomized, phase 3 VIKTORIA-1 trial.

The presentation (RF7-04, Rapid Fire 7) by Barbara Pistilli, MD, is scheduled for December 11, 2025 and will include additional subgroup efficacy analyses and safety data for gedatolisib plus fulvestrant with or without palbociclib as second-line treatment for HR+/HER2-/PIK3CA-WT advanced breast cancer.

The SABCS meeting runs December 9–12, 2025 and the abstract is available on the SABCS website.

News Market Reaction

+0.79%

1 alert

+0.79% News Effect

On the day this news was published, CELC gained 0.79%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Trial phase: Phase 3 Presentation number: RF7-04 Presentation date: December 11, 2025 +1 more

4 metrics

Trial phase Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA-WT advanced breast cancer

Presentation number RF7-04 SABCS Rapid Fire 7 session identifier

Presentation date December 11, 2025 SABCS oral presentation of updated VIKTORIA-1 data

Symposium dates December 9–12, 2025 2025 San Antonio Breast Cancer Symposium schedule

Market Reality Check

Price: $114.48 Vol: Volume 753,871 is below 2...

normal vol

$114.48 Last Close

Volume Volume 753,871 is below 20-day average 966,837 (relative volume 0.78x). normal

Technical Price 100.77 is trading above 200-day MA 37.08.

Peers on Argus

Peers show mixed moves: APGE +0.45%, FOLD +0.61%, TVTX +1.71%, while CGON -2.09%...

Peers show mixed moves: APGE +0.45%, FOLD +0.61%, TVTX +1.71%, while CGON -2.09% and IBRX -4.78%, suggesting stock-specific drivers for CELC.

Common Catalyst One peer (CGON) had management-related news; no broad clinical or sector theme visible.

Historical Context

5 past events · Latest: Nov 26 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 26	SABCS trial update	Positive	+0.8%	Oral SABCS slot for updated VIKTORIA-1 PIK3CA wild-type data.
Nov 26	Investor conference	Neutral	+1.3%	Evercore healthcare conference appearance and webcast details.
Nov 17	NDA completion	Positive	-0.5%	Completion of FDA NDA submission for gedatolisib under RTOR.
Nov 12	Earnings & clinical	Positive	+7.6%	Q3 2025 results plus detailed VIKTORIA-1 PIK3CA WT efficacy data.
Nov 05	Earnings scheduling	Neutral	+2.2%	Announcement of timing and access details for Q3 2025 call.

Pattern Detected

Recent news often aligns with price moves, with one notable divergence on the NDA completion headline.

Recent Company History

Over recent months, Celcuity has advanced gedatolisib through late-stage development, with key milestones including positive Phase 3 VIKTORIA-1 PIK3CA wild-type data, Q3 2025 financials, and completion of a New Drug Application submission on November 17, 2025. Conference and corporate events on November 12–26, 2025 generally saw shares react positively. Today’s SABCS oral presentation notice extends the sequence of detailed VIKTORIA-1 updates, focusing on subgroup efficacy and safety within the same PIK3CA wild-type Phase 3 program.

Market Pulse Summary

This announcement adds granularity to Celcuity’s VIKTORIA-1 program, highlighting an oral SABCS pres...

Analysis

This announcement adds granularity to Celcuity’s VIKTORIA-1 program, highlighting an oral SABCS presentation on updated PIK3CA wild-type Phase 3 data scheduled for December 11, 2025. The focus on subgroup efficacy and safety complements prior topline and NDA-related disclosures. Investors tracking the story may focus on how these details refine the overall benefit–risk profile of gedatolisib combinations in HR+/HER2- advanced breast cancer and how they integrate with previous VIKTORIA-1 outcomes.

Key Terms

pik3ca, pi3k/akt/mtor, fulvestrant, palbociclib, +2 more

6 terms

pik3ca medical

"Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1"

PIK3CA is a gene that helps control cell growth and survival by sending signals inside cells; when it carries certain mutations, those signals can become stuck in the “on” position and drive cancer growth. For investors, PIK3CA matters because its mutations are a biomarker used to identify patients for targeted drugs and diagnostics, affecting clinical trial design, approval chances, and potential market size for therapies aimed at those mutations.

pi3k/akt/mtor medical

"Gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant"

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.

fulvestrant medical

"plus fulvestrant with or without palbociclib for second-line (2L) treatment"

Fulvestrant is a prescription anti-cancer medication given by injection that treats certain hormone-driven breast cancers by blocking estrogen’s influence on tumor cells and promoting removal of the receptors those cells use to grow. Investors care about fulvestrant because clinical trial results, regulatory approvals, pricing and sales determine revenue potential and competitive position for drug makers—like whether a new product becomes a dependable new revenue engine.

palbociclib medical

"plus fulvestrant with or without palbociclib for second-line (2L) treatment"

Palbociclib is an oral cancer medicine that slows tumor growth by blocking proteins cancer cells use to multiply, acting like a temporary brake on cell division. Investors watch palbociclib because its clinical results, regulatory approvals, patent status and sales directly influence a drug maker’s revenues and valuation; positive trial data or new approvals can boost future earnings, while setbacks or generic competition can reduce a company’s market value.

hr+/her2- medical

"patients with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer"

A cancer subtype where tumor cells have hormone receptors for estrogen and/or progesterone (HR+) but lack excess HER2 protein (HER2−). Think of receptors as locks: HR+ tumors have locks that can be targeted by hormone-blocking drugs, while HER2− means a different lock is absent, so HER2-targeted medicines won’t work. For investors this classification matters because it determines which therapies are appropriate, how large the patient market is, and which clinical trials and regulatory paths are relevant.

phase 3 medical

"updated results from the randomized, phase 3 VIKTORIA-1 trialAuthor"

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.

MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today 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. The 2025 SABCS is being held virtually and in-person from December 9-12, 2025. The presentation will include additional sub-group efficacy analyses and safety data.

Abstract presentation details are provided below.

Abstract Title: Gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant with or without palbociclib for second-line (2L) treatment of patients with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer (ABC): updated results from the randomized, phase 3 VIKTORIA-1 trial
Author: Barbara Pistilli, MD
Presentation number: RF7-04
Session Title: Rapid Fire 7
Presentation Date: December 11, 2025

For more details about SABCS please visit: https://www.sabcs.org/.

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.

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 will Celcuity (CELC) present at SABCS 2025 and when?

Celcuity will present updated VIKTORIA-1 PIK3CA-WT cohort results on December 11, 2025 (presentation RF7-04).

What cohort and treatment does the VIKTORIA-1 SABCS abstract cover for CELC (CELC)?

The abstract covers the PIK3CA wild-type cohort evaluating gedatolisib plus fulvestrant with or without palbociclib in 2L HR+/HER2-/ABC.

What types of data will Celcuity (CELC) report at the December 11, 2025 presentation?

The presentation will include additional subgroup efficacy analyses and safety data from the VIKTORIA-1 trial.

How can investors access Celcuity's SABCS 2025 abstract and presentation details?

The abstract is available on the SABCS website and the meeting runs December 9–12, 2025; details list presentation RF7-04 at Rapid Fire 7.

What is the clinical context of Celcuity's VIKTORIA-1 data being presented at SABCS 2025?

VIKTORIA-1 is a randomized, phase 3 trial testing gedatolisib (PAM inhibitor) plus fulvestrant ± palbociclib in second-line HR+/HER2-/PIK3CA-WT advanced breast cancer.