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.
Overview
Celcuity Inc (CELC) is a clinical-stage biotechnology company that operates at the intersection of cutting-edge cell-based assays and targeted oncology therapeutics. Leveraging its proprietary CELsignia companion diagnostic platform, Celcuity provides unique, patient-specific cellular assessments by directly analyzing live tumor cells to gauge the functional response of disease-related signaling pathways. This dual approach enables improved decision-making in personalized medicine by identifying the groups of patients most likely to benefit from existing targeted treatments as well as novel therapeutic candidates.
Core Technologies and Capabilities
At the heart of Celcuity’s innovative approach is its state-of-the-art functional cellular analysis platform. This sophisticated system enables clinicians and pharmaceutical partners to measure the effectiveness of drug therapies by directly assessing their impact on the intracellular signaling cascades. Such pathophysiological insights are integral to advancing precision medicine, empowering more informed treatment strategies in the complex oncology landscape.
Clinical-Stage Programs and Therapeutic Focus
The company is notably advancing its lead therapeutic candidate, gedatolisib, a potent inhibitor that uniquely targets multiple facets of the PI3K/AKT/mTOR signaling pathway. Its mechanism of action and pharmacokinetic profile distinguish it from other agents that target individual components of this pathway. Celcuity is actively involved in Phase 3 trials with gedatolisib in combination therapies for patients with HR+/HER2- advanced breast cancer, and it is pursuing additional clinical evaluations in metastatic castration-resistant prostate cancer. These clinical trials not only underscore the potential impact of gedatolisib but also highlight Celcuity’s commitment to developing integrated treatment options that can improve outcomes for solid tumor indications.
Diagnostic Integration and Personalized Medicine
Celcuity fortifies its therapeutic development with its diagnostic capabilities. Through the CELsignia platform, the company broadens its scope by enabling a deeper understanding of a patient’s disease biology. This bespoke diagnostic tool identifies cellular responses and signaling profiles in real time, paving the way for precision treatment strategies. The integration of diagnostic data into the clinical trial process exemplifies how Celcuity is bridging the gap between laboratory insights and patient care.
Competitive Landscape and Market Position
In a highly competitive field of biotechnology, Celcuity distinguishes itself by combining advanced cellular analysis with a robust clinical-stage pipeline focused on oncology. The company’s methodological emphasis on assessing live tumor cells, along with its innovative inhibitor targeting a comprehensive spectrum of the PI3K/mTOR pathway, positions it distinctively among its peers. By continually advancing its diagnostic and therapeutic platforms, Celcuity aims to provide greater clarity on drug efficacy and patient response, crucial parameters in contemporary personalized medicine.
Operational Excellence and Strategic Vision
Celcuity is committed to excellence in research and development, collaborating with clinical investigators and industry stakeholders to refine its product candidates and diagnostic tools. This strategic focus ensures that the company remains well-positioned to address unmet medical needs within the oncology sector. While its clinical trials continue to generate critical insights, the interplay between diagnostic innovation and targeted therapy remains central to Celcuity’s overarching mission to transform personalized cancer treatment.
Conclusion
In summary, Celcuity Inc stands out through its dual-pronged approach, combining sophisticated cell-based assays with the development of novel therapeutic candidates such as gedatolisib. By integrating diagnostic precision with targeted treatment strategies, Celcuity is redefining the paradigms of personalized medicine in oncology, offering a model of operational expertise and scientific rigor that is critical for advancing patient care in a challenging therapeutic landscape.
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.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on oncology targeted therapies, has announced upcoming presentations at two major investor conferences. CEO and Co-founder Brian Sullivan will participate in fireside chats at the Stifel 2024 Healthcare Conference on November 19 at 1:15 p.m. ET and the Jefferies London Healthcare Conference on November 21 at 11:30 a.m. GMT/6:30 a.m. ET. Both events will feature live webcasts and one-on-one investor meetings.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company focused on targeted oncology therapies, has announced it will release its third quarter 2024 financial results after market close on Thursday, November 14, 2024. The company will host a webcast and conference call at 4:30 p.m. Eastern Time on the same day to discuss results and provide a corporate update. Domestic callers can dial 1-800-717-1738, while international callers should use 1-646-307-1865 to participate.
Celcuity Inc. (Nasdaq: CELC) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Plan to initiate Phase 3 VIKTORIA-2 trial for gedatolisib in HR+, HER2- advanced breast cancer, with first patient enrollment expected in Q2 2025.
2. VIKTORIA-1 PIK3CA WT cohort enrollment target expected in Q4 2024, with topline data anticipated in late Q4 2024 or Q1 2025.
3. Raised $129 million in gross proceeds from equity and debt financings, extending operational runway through 2026.
4. Q2 2024 financial results: Total operating expenses of $24.3 million, net loss of $23.7 million ($0.62 per share), and cash position of $283.1 million as of June 30, 2024.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced the schedule for its second quarter 2024 financial results release. The company will disclose its financial performance after the market closes on Wednesday, August 14, 2024. Following the release, management will host a webcast and teleconference at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.
Investors and interested parties can participate in the teleconference by dialing 1-800-717-1738 (domestic) or 1-646-307-1865 (international). Additionally, a live webcast presentation will be accessible via the provided weblink. For those unable to attend the live event, a replay of the webcast will be made available on the Celcuity website.
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