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) 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.
Celcuity (Nasdaq: CELC) announced on November 17, 2025 the completion of its New Drug Application (NDA) submission to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the FDA’s Real-Time Oncology Review (RTOR) program.
The submission is supported by Phase 3 VIKTORIA-1 PIK3CA wild-type cohort data: the gedatolisib-triplet showed a HR 0.24 (PFS 9.3 vs 2.0 months, +7.3 months) and the gedatolisib-doublet showed a HR 0.33 (PFS 7.4 vs 2.0 months, +5.4 months). Gedatolisib holds prior Breakthrough Therapy and Fast Track designations.
Celcuity (Nasdaq: CELC) reported Q3 2025 results and clinical updates on November 12, 2025. The company presented detailed Phase 3 VIKTORIA-1 PIK3CA wild-type results at ESMO showing the gedatolisib triplet HR 0.24 (median PFS 9.3 vs 2.0 months, +7.3 months) and the gedatolisib doublet HR 0.33 (median PFS 7.4 vs 2.0 months, +5.4 months). The PIK3CA mutant cohort is fully enrolled with topline data expected in late Q1 2026–Q2 2026. An NDA submission for gedatolisib based on the WT cohort is on track for Q4 2025 under FDA RTOR. Q3 financials: operating expenses $42.8M, net loss $43.8M ($0.92/share), cash and equivalents $455.0M, and management expects funding through 2027.
Celcuity (Nasdaq: CELC) will release its third quarter 2025 financial results after market close on Wednesday, November 12, 2025.
Management will host a webcast and teleconference the same day at 4:30 p.m. Eastern Time to discuss results and provide a corporate update. Domestic callers may dial 1-800-717-1738, international callers 1-646-307-1865, and a live webcast is available at the provided link. A replay will be posted on the Celcuity website following the event.
Celcuity (Nasdaq: CELC) will present at the Stifel 2025 Healthcare Conference in New York on November 11-13, 2025. CEO and co-founder Brian Sullivan is scheduled for a fireside chat at 10:00 a.m. ET on Tuesday, November 11, 2025. A live webcast will be available via the provided event link and from the company Investors web page, with a replay posted shortly after the live session.
Celcuity (Nasdaq: CELC) presented detailed Phase 3 VIKTORIA-1 PIK3CA wild-type results at ESMO 2025 showing gedatolisib regimens substantially improved outcomes in HR+/HER2- advanced breast cancer after prior CDK4/6 and aromatase inhibitor therapy.
The gedatolisib triplet median PFS was 9.3 months vs 2.0 months (increment +7.3 months; HR=0.24; 95% CI 0.17-0.35; p<0.0001); the doublet median PFS was 7.4 vs 2.0 months (increment +5.4 months; HR=0.33; 95% CI 0.24-0.48; p<0.0001). ORR was 31.5% (triplet) and 28.3% (doublet) vs 1% control; median DOR 17.5 and 12.0 months.
Safety showed mostly low-grade TRAEs; discontinuation for TRAEs was 2.3% (triplet) and 3.1% (doublet). A rolling NDA is in progress with completion targeted in Q4 2025.
Celcuity (NASDAQ: CELC) reported updated Phase 1 data (data cut-off Aug 15, 2025) for gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (mCRPC).
Key results for 38 patients with median follow-up 9.0 months: combined six-month radiographic PFS 67% and median rPFS 9.1 months. By dose: 120 mg gedatolisib — six-month rPFS 74%, median rPFS 9.5 months; 180 mg — six-month rPFS 61%, median rPFS 7.4 months.
Safety: no dose-limiting toxicities, no Grade 4/5 TRAEs, no treatment discontinuations due to TRAEs; Grade 3 TRAEs included rash 5.3%, stomatitis 2.6%, pruritus 2.6%. The company is enrolling an amended Phase 1/1b to identify the recommended Phase 2 dose.
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