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 of Celcuity Inc.
Celcuity Inc. (Nasdaq: CELC) is a clinical-stage biotechnology company specializing in the development of targeted therapies and companion diagnostics for oncology. Based in Minneapolis, Celcuity aims to transform cancer treatment by leveraging precision medicine to improve therapeutic outcomes for patients with advanced solid tumors. The company’s innovative approach focuses on addressing critical gaps in cancer care by combining its proprietary diagnostic platform with cutting-edge therapeutic candidates.
Therapeutic Innovations: Gedatolisib
Celcuity’s lead therapeutic candidate, gedatolisib, is a potent, reversible inhibitor targeting the PI3K/AKT/mTOR signaling pathway, a critical driver in many cancers. Unlike other therapies that selectively inhibit individual components of this pathway, gedatolisib uniquely targets all Class I PI3K isoforms as well as mTORC1 and mTORC2. This comprehensive mechanism of action minimizes the potential for drug resistance, making it a highly differentiated candidate among currently approved and investigational therapies. Gedatolisib has demonstrated robust clinical efficacy and a manageable safety profile in Phase 1b trials, particularly in patients with HR+/HER2- advanced breast cancer.
The drug is currently being evaluated in multiple clinical trials, including:
- VIKTORIA-1: A Phase 3 trial assessing gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with HR+/HER2- advanced breast cancer.
- CELC-G-201: A Phase 1b/2 trial exploring gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer.
- VIKTORIA-2: An upcoming Phase 3 trial investigating gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer in combination with a CDK4/6 inhibitor and fulvestrant.
Diagnostic Breakthrough: CELsignia Platform
Complementing its therapeutic efforts, Celcuity has developed the CELsignia companion diagnostic platform, a proprietary technology designed to analyze live tumor cells and identify patients most likely to benefit from specific targeted therapies. Unlike traditional genomic or proteomic diagnostics, CELsignia assesses the functional activity of signaling pathways in real-time, providing actionable insights for personalized treatment strategies. This platform has the potential to redefine patient selection and improve clinical trial outcomes by identifying previously unrecognized patient subgroups.
Strategic Positioning in Oncology
Celcuity operates at the forefront of precision oncology, a rapidly growing segment of the biotechnology industry. By combining innovative drug development with advanced diagnostics, the company addresses the increasing demand for personalized medicine. Its focus on solid tumor indications, particularly HR+/HER2- advanced breast cancer and metastatic prostate cancer, positions it within high-need therapeutic areas. The FDA’s Breakthrough Therapy designation for gedatolisib underscores its potential to deliver significant clinical benefits.
Challenges and Opportunities
As a clinical-stage biotechnology company, Celcuity faces challenges typical of its industry, including the high costs and risks associated with clinical trials and regulatory approvals. However, its differentiated approach and robust pipeline provide significant opportunities for growth. The company’s focus on combination therapies and its ability to address resistance mechanisms in cancer treatment set it apart from competitors.
Conclusion
Celcuity Inc. is a pioneering force in the biotechnology sector, combining innovative targeted therapies with advanced diagnostic solutions to address unmet needs in oncology. Its dual focus on gedatolisib and the CELsignia platform highlights its commitment to advancing precision medicine and improving patient outcomes. With multiple clinical trials underway and a strong foundation in personalized oncology, Celcuity is well-positioned to make a lasting impact on cancer treatment.
Celcuity Inc. (NASDAQ:CELC) has made significant strides in its Phase 3 VIKTORIA-1 clinical trial for gedatolisib, completing the selection of 200 clinical sites and activating the first site. The FDA granted Breakthrough Therapy designation for gedatolisib in July 2022, expediting the review process. Financially, the company reported a net loss of $10.9 million for Q3 2022, up from $6.0 million in Q3 2021, with total operating expenses at $10.6 million. Cash and cash equivalents stood at $57.5 million as of September 30, 2022.
Celcuity Inc. (NASDAQ:CELC) will release its financial results for Q3 2022 on November 10, 2022, after market close. Management will host a webcast and conference call at 4:30 p.m. ET the same day to discuss the results. Celcuity is focused on developing targeted therapies for various cancers, with its leading candidate, gedatolisib, targeting Class 1 PI3K isoforms and mTOR. A Phase 3 study for gedatolisib in patients with HR+/HER2- advanced breast cancer is expected to begin soon.
Celcuity Inc. (NASDAQ:CELC) has announced the appointment of Polly Murphy, D.V.M., Ph.D. to its Board of Directors on September 14, 2022. Dr. Murphy brings over 20 years of experience in pharmaceutical business development, including leadership roles at Pfizer. Her expertise includes overseeing global marketing and strategy in oncology. As Chief Business Officer at UroGen Pharma, she enhances Celcuity's strategic capabilities, especially as the company advances its lead candidate, gedatolisib, towards a Phase 3 clinical trial for HR+/HER2- advanced breast cancer.
On August 11, 2022, Celcuity announced key developments including the FDA granting Breakthrough Therapy designation for its drug gedatolisib in treating HR+/HER2- advanced breast cancer. The company entered into a $100 million private placement agreement and expanded its debt facility from $25 million to $75 million to finance operations through 2025. The Phase 3 VIKTORIA-1 clinical trial is on track to begin dosing patients soon. Despite a net loss of $10 million in Q2 2022, operating expenses were reduced significantly, indicating a focus on maintaining financial health.
Celcuity Inc. (NASDAQ:CELC), a biotechnology firm concentrating on targeted therapies for hormonally driven cancers, will release its Q2 2022 financial results on August 11, 2022, after market close. A webcast/teleconference will follow at 4:30 p.m. Eastern Time for discussion of the results and corporate updates. Celcuity's lead candidate, gedatolisib, is a dual inhibitor targeting Class I PI3K isoforms and mTOR, with a Phase 3 study expected to begin in 2022 for HR+/HER2- advanced breast cancer. The CELsignia platform identifies patients likely to benefit from targeted therapies.
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company, announced its participation in the Canaccord Genuity 42nd Annual Growth Conference in Boston from August 8-11, 2022. CEO Brian Sullivan will present on August 10 at 11:30 a.m. ET. A live webcast will be accessible via this link and from the company's Investors section. Celcuity focuses on developing targeted therapies for hormonally driven cancers, including its lead candidate gedatolisib, expected to enter Phase 3 trials for advanced breast cancer in 2022.
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company, has received FDA Breakthrough Therapy designation for gedatolisib, a potential treatment for HR+/HER2- metastatic breast cancer in patients whose condition has worsened after receiving CDK4/6 therapy and an aromatase inhibitor. This designation enables expedited development and review, emphasizing gedatolisib's potential to improve significant clinical outcomes. Gedatolisib acts as a pan-PI3K/mTOR inhibitor and is set to enter Phase 3 clinical trials in 2022.
MINNEAPOLIS, MN / ACCESSWIRE / May 26, 2022 / Celcuity (NASDAQ:CELC) announced that CEO Brian Sullivan will participate in two investor conferences: the 19th Annual Craig-Hallum Institutional Investor Conference on June 1, 2022 (virtual), and a fireside chat at the Jefferies Healthcare Conference in New York on June 9, 2022, at 2:30 p.m. ET. A live webcast will be available for the Jefferies event. Celcuity focuses on advancing cancer treatment through its lead candidate, gedatolisib, and its CELsignia companion diagnostic platform, aiming for a Phase 3 study in HR+/HER2- advanced breast cancer.
Celcuity (NASDAQ:CELC) announced a $100 million private placement agreement aimed at supporting the clinical development of gedatolisib for HR+/HER2- advanced breast cancer. The company reported a net loss of $7.9 million or $0.53 per share for Q1 2022, compared to a loss of $2.8 million or $0.25 per share in Q1 2021. Operating expenses grew to $7.5 million, significantly driven by R&D costs for gedatolisib. The FDA granted Fast Track designation for gedatolisib, positioned to address unmet needs in targeted therapies.
Celcuity Inc. (Nasdaq:CELC) announced a $100 million private placement to advance gedatolisib clinical development, specifically the Phase 3 study VIKTORIA-1. Lead investor Venrock Healthcare Capital Partners participated alongside others, with shares priced at $5.75. The placement will support clinical activities and general corporate needs. The closing hinges on the first patient enrollment in VIKTORIA-1, anticipated by year-end 2022. Results are expected in late 2024. The company also plans to register resale securities with the SEC.
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