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. (NASDAQ: CELC) is a clinical-stage biotechnology company headquartered in Minneapolis and focused on targeted therapies for oncology. News about Celcuity primarily centers on the development of its lead investigational drug, gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) pathway inhibitor being studied in multiple solid tumor indications, including HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
On this page, readers can follow Celcuity’s clinical trial milestones, such as topline and detailed results from the Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA wild-type and mutant advanced breast cancer, as well as updates on the Phase 3 VIKTORIA-2 first-line trial and the Phase 1/2 CELC-G-201 study of gedatolisib plus darolutamide in mCRPC. Company press releases frequently report progression-free survival data, objective response rates, safety outcomes, and subgroup analyses from these studies.
Celcuity’s news flow also includes regulatory and corporate developments, such as the submission of a New Drug Application to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the Real-Time Oncology Review program, participation in major medical meetings like the ESMO Congress and the San Antonio Breast Cancer Symposium, and presentations at healthcare investment conferences. In addition, the company announces financing transactions, including equity offerings, convertible senior notes, and amendments to its term loan facilities that support ongoing clinical and potential commercial activities.
Investors and healthcare professionals can use this news feed to monitor Celcuity’s latest disclosures on gedatolisib’s clinical performance, safety profile, regulatory progress, and capital strategy. Regular updates provide context on how the company’s oncology pipeline is advancing through late-stage development and regulatory review.
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.
Celcuity (Nasdaq: CELC) announced FDA acceptance of its New Drug Application for gedatolisib to treat HR+/HER2-/PIK3CA wild-type advanced breast cancer. The FDA granted Priority Review, assigned a PDUFA goal date of July 17, 2026, and accepted the NDA under the FDA’s Real-Time Oncology Review (RTOR) program. The submission uses data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial. Gedatolisib is an investigational multi-target PI3K/AKT/mTOR (PAM) inhibitor that targets all four Class I PI3K isoforms and both mTOR complexes. The program previously received Breakthrough Therapy and Fast Track designations.
Celcuity (NASDAQ: CELC) presented updated Phase 3 VIKTORIA-1 results for gedatolisib in HR+, HER2-, PIK3CA wild-type advanced breast cancer at SABCS on Dec 11, 2025. Key efficacy: for patients with prior therapy time-to-progression >18 months, median PFS was 12.4 months (triplet) and 10.0 months (doublet) versus 1.9 months for fulvestrant; for patients in U.S./Canada/Western Europe/Asia Pacific median PFS was 16.6 months (triplet) and 7.1 months (doublet) versus 1.9 months for fulvestrant. Patient-reported well-being deterioration was delayed (median 23.7 months triplet). Safety: stomatitis was generally manageable; no clinically relevant hyperglycemia observed.
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.
Celcuity (Nasdaq: CELC) will present at the 8th Annual Evercore Healthcare Conference in Miami, Florida on December 2-4, 2025. CEO and co-founder Brian Sullivan is scheduled for a fireside chat at 7:30 a.m. ET on December 3, 2025. A live webcast will be available at https://wsw.com/webcast/evercore52/celc/2320846 and from the company's investor events page at https://ir.celcuity.com/events-presentations/, with a replay posted shortly after.