Welcome to our dedicated page for Celcuity news (Ticker: CELC), a resource for investors and traders seeking the latest updates and insights on Celcuity stock.
Celcuity Inc. develops targeted oncology therapies as a clinical-stage biotechnology company, with news centered on gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor for solid tumors. Company updates frequently cover Phase 3 VIKTORIA-1 data in HR+/HER2- advanced breast cancer, including PIK3CA wild-type and mutant cohorts and combination regimens with fulvestrant and palbociclib.
Recurring announcements also address FDA regulatory submissions and review status for gedatolisib, publications and medical-meeting presentations, quarterly financial results, corporate updates, investor conference participation, and board governance changes.
Celcuity (Nasdaq: CELC) reported Q1 2026 results and key updates for gedatolisib in HR+/HER2- advanced breast cancer.
The Phase 3 VIKTORIA-1 trial met its primary endpoint with statistically significant, clinically meaningful PFS benefit in PIK3CA mutant patients; an NDA has Priority Review with a July 17, 2026 PDUFA date. Cash was $387.1 million, expected to fund operations through 2027.
Celcuity (Nasdaq: CELC) updated its Phase 3 VIKTORIA-2 trial of gedatolisib as first-line therapy for HR+/HER2- advanced breast cancer. The trial now includes separate studies for endocrine-resistant and endocrine-sensitive patients, each with independent statistical plans and PFS primary endpoints.
According to Celcuity, prior Phase 1b data in endocrine-sensitive patients treated with gedatolisib plus palbociclib and letrozole showed median PFS of 48.6 months, median OS of 77.3 months, and a 79% objective response rate. The company also submitted its first patent application for a subcutaneous gedatolisib formulation and is developing it to demonstrate clinical equivalence to the current IV form.
Celcuity (Nasdaq: CELC) will release first quarter 2026 financial results after market close on Thursday, May 14, 2026. Management will host a live webcast and teleconference the same day at 4:30 p.m. Eastern Time to review results and provide a corporate update. A webcast replay will be available on the company website.
Celcuity (NASDAQ: CELC) reported positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial. The gedatolisib triplet (gedatolisib+fulvestrant+palbociclib) met the primary endpoint with a statistically significant, clinically meaningful improvement in progression-free survival versus alpelisib+fulvestrant; the gedatolisib doublet also showed a significant PFS benefit. Both regimens were generally well tolerated with manageable safety. Celcuity plans an sNDA submission to the FDA and will present detailed data at ASCO 2026 (June 2, 2026).
Celcuity (NASDAQ: CELC) reported Phase 3 and corporate updates on March 25, 2026. Key clinical milestones include FDA acceptance of the gedatolisib NDA with Priority Review and a PDUFA date of July 17, 2026, and publication of PIK3CA WT VIKTORIA-1 results showing PFS 16.6 vs 1.9 months (HR=0.14).
Financially, 2025 operating expenses and net loss widened versus 2024; cash and short-term investments were $441.5M, expected to fund operations through 2027.
Celcuity (Nasdaq: CELC) will release fourth quarter and full year 2025 financial results after market close on Wednesday, March 25, 2026. Management will host a webcast/teleconference at 4:30 p.m. ET the same day to discuss results and provide a corporate update.
Domestic dial-in is 1-800-717-1738, international dial-in is 1-646-307-1865, and a live webcast is available via the company link; a replay will be posted on Celcuity's website.
Celcuity (NASDAQ: CELC) announced publication of Phase 3 VIKTORIA-1 PIK3CA wild-type cohort results in Journal of Clinical Oncology on March 9, 2026.
The gedatolisib triplet (gedatolisib+palbociclib+fulvestrant) showed median PFS 9.3 vs 2.0 months (HR=0.24; p<0.0001) and ORR 31.5%. The doublet showed median PFS 7.4 vs 2.0 months (HR=0.33; p<0.0001) and ORR 28.3%. FDA granted Priority Review with a PDUFA goal date of July 17, 2026.
Celcuity (Nasdaq: CELC) announced CEO and co-founder Brian Sullivan will present and hold investor meetings at three investor conferences in March 2026. Presentations include a fireside chat at the TD Cowen Healthcare Conference on March 4, 2026 and at the Leerink Global Healthcare Conference on March 10, 2026, plus investor meetings at Jefferies Biotech on the Beach on March 11, 2026.
Live webcasts will be available via provided summitcast links and the company’s Investors page, with replays posted shortly after each live event.
Celcuity (Nasdaq: CELC) appointed Charles (Chip) R. Romp to its Board of Directors effective Feb. 12, 2026. Mr. Romp brings 25+ years of pharmaceutical commercial experience, currently serves as CEO of Secura Bio, and has led major oncology commercial organizations.
Management expects Romp's commercialization expertise to support Celcuity's programs and the potential approval and launch of gedatolisib later in 2026.
Celcuity (Nasdaq: CELC) will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on February 11-12, 2026. CEO and co‑founder Brian Sullivan will appear for a fireside chat at 9:30 a.m. ET on February 11, 2026. A live webcast and replay will be available via the company's Investors website.