Celcuity Inc.（CELC）資訊與事件CELCCelcuity Inc.

Celcuity Announces New Data from VIKTORIA-1 Study

Celcuity announced new subgroup analyses from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study evaluating gedatolisib in patients with HR+/HER2- locally advanced or metastatic breast cancer. These data were presented by Dr. Barbara Pistilli, Head of the Breast Cancer Unit, Gustave Roussy, at the European Society of Medical Oncology Congress 2026. Key highlights: Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases; ORR and median duration of response was 59% and 19.4 months for the gedatolisib triplet and 43% and 27.8 months for the gedatolisib doublet, respectively, compared to 33% and 7.5 months for alpelisib + fulvestrant; The discontinuation rate for gedatolisib due to treatment-emergent adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib

Celcuity Updates Clinical Results for Gedatolisib

Celcuity announced updated clinical results from the Phase 1b/2 study evaluating gedatolisib in patients with metastatic castration-resistant prostate cancer, or mCRPC. These data were presented at the European Society of Medical Oncology, or ESMO, Congress on Friday, October 23, 2026, at 9:15 a.m. EDT/3:15 p.m. CEST at a poster presentation: In this Phase 1b/2 study, 45 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1, 180 mg gedatolisib in Arm 2 and 240 mg gedatolisib in Arm 3. In all arms, gedatolisib was administered intravenously on days 1, 8, and 15 of a 28-day cycle, then two weeks off. Additionally, all patients received prophylactic treatment for stomatitis. Baseline characteristics were generally consistent across dose cohorts; over 50% had bone disease, 33% had phosphatase and tensin hemolog loss. Data was analyzed as of an August 14 cut-off date. Median rPFS was 15.7 months with an rPFS6 rate of 82.2% in patients with prior abiraterone exposure. Median rPFS was 9.1 months with an rPFS6 rate of 62.5% in patients with prior enzalutamide exposure. PSA greater than or equal to 50% decreases from baseline were observed across all dose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and 240-mg gedatolisib dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide. Exploratory analyses of patients according to their PTEN status suggest activity is independent of PTEN status. Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels with one dose limiting toxicity, no Grade 4/5 treatment related adverse events, and no TRAEs leading to treatment discontinuation or death. Grade 3 TRAEs occurred in 9 patients with only rash and pruritus occurring in more than one patient. The randomized Phase 2 study is expected to evaluate two different groups of patients with the objective of determining the recommended phase 3 dose level. Subjects in Group 1 will be those who received prior abiraterone for either hormone sensitive or castration resistant prostate cancer. Subjects in Group 2 will be those who received prior enzalutamide or apalutamide for either hormone sensitive or castration resistant prostate cancer. Celcuity anticipates initiating this study in the first half of 2027 after completion of the Phase 1b part of the study.

Celcuity Appoints David Gryska to Board of Directors

Celcuity (CELC) announced the appointment of David Gryska to its Board of Directors. Throughout the past 25 years, Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics (DFTX)