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) 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) 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) 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), 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.
Celcuity (NASDAQ:CELC) has significantly expanded its senior secured credit facility with Innovatus Capital Partners and Oxford Finance to $500 million, up from its previous amount. The enhanced facility includes $350 million in committed capital and an additional $150 million at mutual discretion.
The amendment provides $170 million in new committed capital, including $100 million tied to FDA approval of gedatolisib for second-line wild-type advanced breast cancer, and $120 million linked to commercial revenue milestones. The initial funding was $30 million, bringing the total outstanding loan to $130 million. The deal extends the interest-only period by 14 months, with a potential 7-month extension upon FDA approval.
Celcuity (NASDAQ:CELC) announced that the FDA has agreed to review its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer under the Real-Time Oncology Review program. The company plans to initiate a rolling submission in September 2025, with completion targeted for Q4 2025.
The submission is based on groundbreaking Phase 3 VIKTORIA-1 trial results where the gedatolisib-triplet therapy reduced disease progression risk by 76% compared to fulvestrant alone, with a median PFS of 9.3 vs 2.0 months. The gedatolisib-doublet showed a 67% risk reduction with median PFS of 7.4 vs 2.0 months. These results represent unprecedented improvements in HR+/HER2- advanced breast cancer treatment.