(RTTNews) - Celcuity Inc. (CELC), a clinical-stage biotechnology company developing targeted therapies for solid tumors, reported fourth-quarter and full-year 2025 financial results and outlined key clinical and regulatory milestones expected to shape the company's progress in 2026.
The company said the U.S. FDA has accepted its NDA for Gedatolisib in HR+/HER2/PIK3CA wild-type advanced breast cancer and granted Priority Review, assigning a PDUFA goal date of July 17, 2026. Updated efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial were recently published in the Journal of Clinical Oncology, and topline results from the PIK3CA-mutant cohort are expected in the second quarter of 2026.
For the fourth quarter of 2025, Celcuity reported a net loss of $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, for the fourth quarter of 2024.
For the full year, the company posted a net loss of $177.0 million, or $3.79 per share, compared to a net loss of $111.8 million, or $2.83 per share, in 2024.
Celcuity said it anticipates a transformative year ahead, with preparations underway for a potential commercial launch of Gedatolisib, pending FDA approval. The company also expects to release topline data from the PIK3CA-mutant cohort of VIKTORIA-1 in the second quarter of 2026.
Celcuity's pipeline is centered on Gedatolisib, PI3K and mTORC1/2 inhibitor targeting the PAM pathway. The program includes multiple ongoing clinical studies.
The Phase 3 VIKTORIA-1 trial evaluating Gedatolisib with Fulvestrant, with or without Palbociclib in HR+/HER2- advanced breast cancer has completed enrolment, with detailed results already reported for the PIK3CA wild-type cohort.
A second Phase 3 study, VIKTORIA-2, is evaluating Gedatolisib plus a CDK4/6 inhibitor and Fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer. In addition, a Phase 1/2 trial, CELC G-201, is assessing Gedatolisib in combination with Darolutamide in patients with metastatic castration-resistant prostate cancer.
Celcuity ended the year with $441.5 million in cash, cash equivalents and short-term investments, which it expects will fund operations through 2027.
CELC has traded between $7.57 and $120.32 over the past year. The stock closed Wednesday's trading at $110.22, up 8.05%. In pre-market trading the stock is trading at $108.45, down 1.61%.
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