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) 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.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced it will release its Q4 and full year 2024 financial results after market close on Monday, March 31, 2025.
The company will host a webcast/conference call at 4:30 p.m. Eastern Time on the same day, where management will discuss the results and provide a corporate update. Domestic participants can dial 1-800-717-1738, while international callers should use 1-646-307-1865 to join the teleconference.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced its participation in two upcoming investor conferences.
Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, will represent the company at both events where he will present and be available for one-on-one investor meetings.
The first appearance will be a fireside chat at the TD Cowen 45th Annual Health Care Conference in Boston on Tuesday, March 4, 2025, at 10:30 a.m. ET. The second presentation will take place at the Leerink Global Healthcare Conference 2025 in Miami on Wednesday, March 12, 2025, at 9:20 a.m. ET.
Live webcasts of both presentations will be available through dedicated weblinks provided in the announcement.
Celcuity (CELC) announced overall survival (OS) data from a Phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy for HR+, HER2- advanced breast cancer. The study showed promising results with a median OS of 77.3 months in treatment-naïve patients and 33.9 months in patients previously treated with CDK4/6 inhibitors.
The data was presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The trial results support Celcuity's clinical development strategy of simultaneously blocking ER, CDK4/6, and PAM signaling pathways, which forms the basis for their ongoing VIKTORIA-1 and planned VIKTORIA-2 Phase 3 trials.
Celcuity Inc. (CELC) announced its Q3 2024 financial results and corporate updates. The company reported 100% enrollment completion for the PIK3CA wild-type cohort in the Phase 3 VIKTORIA-1 trial, with topline data expected in late Q1 2025 or Q2 2025. The PIK3CA mutant cohort data is anticipated in H2 2025. Financial highlights include $264.1 million in cash and investments, expected to fund operations through 2026. Q3 operating expenses were $30.1 million, with a net loss of $29.8 million ($0.70 per share). R&D expenses increased to $27.6 million, primarily due to clinical trial activities and increased personnel costs.
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