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 (CELC) delivers innovative oncology solutions through its integrated approach combining advanced cellular diagnostics with targeted therapeutic development. This dedicated news hub provides investors and researchers with essential updates on clinical milestones, regulatory developments, and strategic partnerships.
Access authoritative information about Celcuity's Phase 3 trials for gedatolisib in advanced breast cancer, progress in prostate cancer research, and advancements in their CELsignia companion diagnostic platform. Our curated collection includes press releases about trial enrollments, partnership announcements with pharmaceutical leaders, and financial disclosures critical for market analysis.
Key updates cover therapeutic pipeline progress, diagnostic technology enhancements, and scientific presentations at major oncology conferences. The resource serves both expert analysts and general investors seeking to understand Celcuity's position in precision medicine.
Bookmark this page for real-time access to verified CELC developments. For comprehensive tracking of this clinical-stage biotech leader's progress in personalized cancer treatment, revisit regularly as new information becomes available.
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.
Celcuity (NASDAQ: CELC) announced the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is fully enrolled and that topline data are expected in late Q1 2026 or Q2 2026.
Celcuity also released updated analysis from a Phase 1b trial of gedatolisib plus fulvestrant and palbociclib: for PIK3CA-mutated advanced HR+/HER2- breast cancer (n=30) median PFS was 14.6 months with an ORR of 48%; in the subgroup receiving the intermittent dose (n=11) median PFS was 19.7 months with ORR 64%. For PIK3CA wild-type (n=60) median PFS was 9.0 months and ORR 41%.
Celcuity (NASDAQ:CELC), a clinical-stage biotech company, has announced that results from its pivotal Phase 3 VIKTORIA-1 trial will be presented at the 2025 ESMO Congress in October. The late-breaking presentation will focus on efficacy and safety data from the PIK3CA wild-type cohort, specifically examining gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in HR+/HER2- advanced breast cancer patients.
The presentation is scheduled for October 18, 2025, from 10:15 am to 11:45 am CEST, with the abstract number 3535. The late-breaking abstracts will be published on ESMO's website on the presentation day.
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