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.

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.