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) priced an upsized underwritten public offering of $500 million 0.250% convertible senior notes due 2032, increased from $400 million. The notes carry a 0.250% annual coupon, mature August 1, 2032, and are senior unsecured obligations.
The initial conversion rate is 8.0302 CELC shares per $1,000 principal (conversion price about $124.53, a 40% premium). Net proceeds are estimated at $484.3 million (or $557.0 million with full over-allotment), to repay Celcuity’s Oxford Finance loan and fund working capital, clinical and commercialization activities, and general corporate purposes.
Celcuity (Nasdaq: CELC) announced a proposed underwritten public offering of $400 million convertible senior notes due 2032, with a $60 million over-allotment option.
According to Celcuity, net proceeds will repay its Oxford Finance loan in full, with the balance for working capital and general corporate purposes.
Celcuity (Nasdaq: CELC) reported detailed Phase 3 VIKTORIA-1 results in PIK3CA-mutant HR+/HER2- advanced breast cancer. Gedatolisib plus fulvestrant and palbociclib cut risk of progression or death by 50% vs alpelisib/fulvestrant (HR=0.50) with median PFS 11.1 vs 5.6 months and ORR 48.9% vs 26.0%.
The gedatolisib doublet showed HR=0.51 and median PFS 11.3 months. Safety was generally manageable with low discontinuation rates. Celcuity plans an sNDA for PIK3CA-mutant disease and already has Priority Review for PIK3CA wild-type, with a PDUFA date of July 17, 2026.
Celcuity (Nasdaq: CELC) will host a conference call and live webcast on June 2, 2026 to discuss results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial in HR+/HER2- advanced breast cancer.
The event begins at 8:00 a.m. EDT / 7:00 a.m. CDT, with a replay available on Celcuity's website.
Celcuity (Nasdaq: CELC) announced CEO Brian Sullivan will present and hold one-on-one investor meetings at two upcoming healthcare investor conferences in June 2026.
Both fireside chats at Jefferies and Goldman Sachs will be available via live webcast and replay through dedicated links and the company’s investor relations website.
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.