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 breakthrough topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial evaluating gedatolisib combinations for HR+/HER2- advanced breast cancer. The gedatolisib triplet therapy showed a 76% reduction in disease progression risk (HR=0.24) with 9.3 months median PFS vs. 2.0 months for fulvestrant alone. The gedatolisib doublet demonstrated a 67% reduction (HR=0.33) with 7.4 months median PFS.
These results represent unprecedented efficacy in HR+/HER2- advanced breast cancer treatment, with both combinations showing better safety profiles than previous trials. Treatment discontinuation rates were lower than observed in Phase 1b and other Phase 3 trials. Celcuity plans to submit a New Drug Application to the FDA in Q4 2025, with full data presentation scheduled for later this year.
Celcuity (NASDAQ:CELC), a clinical-stage biotechnology company focused on targeted oncology therapies, has scheduled a conference call and webcast for July 28, 2025, at 8:00 AM ET to present topline results from the PIK3CA Wild-Type Cohort of their Phase 3 VIKTORIA-1 trial in HR+/HER2- advanced breast cancer.
The management team will host the presentation with a live webcast available, and participants can register for the teleconference in advance. A replay will be accessible on Celcuity's website after the event.
Celcuity (NASDAQ:CELC) has initiated patient dosing in its Phase 3 VIKTORIA-2 clinical trial, evaluating gedatolisib combination therapy as a first-line treatment for HR+/HER2- advanced breast cancer (ABC) patients with endocrine therapy resistance.
Gedatolisib, a novel multi-target PI3K/AKT/mTOR inhibitor, demonstrated promising results in a Phase 1b trial when combined with palbociclib and letrozole, achieving a median progression-free survival of 48.6 months, median overall survival of 77.3 months, and an objective response rate of 79%.
The VIKTORIA-2 study aims to evaluate gedatolisib's efficacy in combination with CDK4/6 inhibitor and fulvestrant, regardless of patients' PIK3CA status or metabolic profile.
Celcuity (Nasdaq: CELC) has secured a new U.S. patent (No. 12,350,276) for the clinical dosing regimen of gedatolisib, its lead drug candidate for ER+/HER2- breast cancer patients. This patent extends the company's exclusivity until 2042.
The company's gedatolisib patent portfolio now includes 13 U.S. patents and 290 foreign patents, covering composition, formulations, and methods of use. Celcuity expects to release topline data from the VIKTORIA-1 clinical trial for the PIK3CA wild-type cohort in Q3 2025 and the PIK3CA mutant cohort in Q4 2025.
Celcuity (NASDAQ:CELC) has reported promising clinical data from two early-phase studies of gedatolisib, their multi-target inhibitor drug. The first study, a Phase 1 trial in metastatic castration-resistant prostate cancer (mCRPC), showed a 66% six-month radiographic progression-free survival rate when gedatolisib was combined with darolutamide.
In the second study, a Phase 2 trial for HER2+ metastatic breast cancer, gedatolisib combined with trastuzumab-pkrb demonstrated an objective response rate of 43% in heavily pre-treated patients. The median progression-free survival was 6.0 months, with median overall survival reaching 24.7 months.
Both studies demonstrated favorable safety profiles, with no patients discontinuing gedatolisib due to treatment-related adverse events. The company is now exploring additional dosing options in the mCRPC trial, with plans to enroll more patients across multiple cohorts to determine the recommended Phase 2 dose.
Celcuity Inc. (NASDAQ: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced upcoming presentations at two major investor conferences. CEO and Co-founder Brian Sullivan will participate in:
- A fireside chat at the TD Cowen 6th Annual Oncology Innovation Summit on May 28, 2025, at 9:30 a.m. ET
- A fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, at 7:35 a.m. ET
Both presentations will be available via live webcast and can be accessed through the company's investor relations website, with recordings available shortly after the events.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced the timing for its Q1 2025 financial results release. The company will release its results after market close on Wednesday, May 14, 2025, followed by a management-hosted webcast and conference call at 4:30 p.m. Eastern Time. Domestic participants can dial 1-800-717-1738, while international callers should use 1-646-307-1865. A live webcast will be available, and a replay will be accessible on Celcuity's website after the event.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company focused on targeted oncology therapies, has announced its participation in two upcoming investor conferences in April 2025.
CEO and Co-founder Brian Sullivan will present at:
- The Stifel 2025 Virtual Targeted Oncology Forum on Wednesday, April 9, 2025, at 10:00 a.m. ET
- The 24th Annual Needham Virtual Healthcare Conference on Thursday, April 10, 2025, at 11:00 a.m. ET
Both presentations will be available via live webcast and can be accessed through the company's investor relations website, with replays available after the events.
Celcuity Inc. (NASDAQ: CELC) reported its Q4 and full year 2024 financial results, highlighting several upcoming clinical milestones. The company's VIKTORIA-1 Phase 3 trial's PIK3CA wild-type cohort is set to report topline data in Q2 2025, while the VIKTORIA-2 Phase 3 trial's first patient enrollment is expected in Q2 2025.
Financial highlights include:
- Q4 2024 net loss of $36.7 million ($0.85 per share)
- Full year 2024 net loss of $111.8 million ($2.83 per share)
- R&D expenses increased to $33.5 million in Q4 2024
- Cash position of $235.1 million expected to fund operations through 2026
The company presented encouraging preliminary overall survival data from their Phase 1b study of gedatolisib combination therapy at the 2024 SABCS, showing median overall survival of 77.3 months in treatment-naïve patients and 33.9 months in previously treated patients.