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) will announce its Q1 2022 financial results on May 16, 2022, post-market close. A webcast and conference call are scheduled for the same day at 4:30 p.m. ET to discuss results and corporate updates. The company is focused on an integrated therapeutic and companion diagnostic strategy for cancer treatment. Its lead drug, gedatolisib, is a dual inhibitor targeting PI3K and mTOR, with a Phase 3 study expected to begin in 2022 for HR+/HER2- advanced breast cancer. More details can be found on its website.
Celcuity Inc. (NASDAQ:CELC) has announced participation in two upcoming virtual investor conferences. Chairman and CEO Brian Sullivan will present at the 21st Annual Needham Healthcare Conference on April 12, 2022, at 3:45 p.m. ET, with a live webcast available here. He will also present at the Canaccord Genuity Horizons in Oncology Conference on April 14, 2022, at 11 a.m. ET, with a live webcast here. Webcasts will be accessible from their website shortly after the events.
Celcuity announced its finalized pivotal Phase 3 trial design for gedatolisib, which received FDA Fast Track designation for HR+/HER2- metastatic breast cancer. The trial, named VIKTORIA-1, will evaluate gedatolisib combined with fulvestrant, with or without palbociclib. Management reported a net loss of $6.8 million for Q4 2021, with total operating expenses reaching $6.3 million. Cash and cash equivalents as of December 31, 2021, totaled $84.3 million, a significant increase from $11.6 million in the prior year. A webcast to discuss these results was held on March 23, 2022.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, announced it will release its financial results for Q4 and full year 2021 on March 23, 2022, after market close. A webcast will follow at 4:30 p.m. ET for discussion of results and corporate updates. Celcuity's mission focuses on extending cancer patients' lives through an integrated therapeutic and diagnostic approach. The CELsignia diagnostic platform uniquely identifies suitable patient groups for existing targeted therapies.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, will participate in the virtual Cowen 42nd Annual Health Care Conference from March 7-9, 2022. Brian Sullivan, the CEO, will join the "Breast Cancer" panel session on March 9 at 2:10 p.m. ET. Investors can access a live webcast of the event via this link or through the company's website, with a replay available post-event.
Celcuity focuses on developing targeted therapies and companion diagnostics to improve cancer treatment.
Celcuity has received FDA Fast Track designation for its drug gedatolisib, aimed at treating HR+/HER2- metastatic breast cancer after CDK4/6 therapy failure. This designation accelerates development and approval opportunities. The company plans to finalize Phase 3 trial design by Q1 2022 and initiate two Phase 2 trials to evaluate gedatolisib in select patients based on CELsignia tests. With an anticipated enrollment of 40%-45% of tested patients qualifying for trials, Celcuity aims to enhance patient screening and maximize participation.
Celcuity Inc. (Nasdaq:CELC) presented updated results from a Phase 1b study at the 2021 San Antonio Breast Cancer Symposium. The study evaluated gedatolisib combined with palbociclib and endocrine therapy for treating women with ER+/HER2- advanced breast cancer. Notably, a 78% objective response rate (ORR) was reported in patients with two or more prior treatments and a 63% ORR overall. Gedatolisib showed good tolerability with minimal discontinuations due to adverse events. The company plans to initiate a Phase 3 trial in the first half of 2022.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology firm, has announced the acceptance of a poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place from December 7-10, 2021. The poster titled "Phase 1b expansion study of gedatolisib in combination with palbociclib and endocrine therapy in women with ER+ advanced breast cancer" will be presented by Dr. Rachel M. Layman on December 10, 2021, during Poster Session 5 from 7 - 8:30 a.m. CT. The presentation will also be available on Celcuity's website.
Celcuity Inc. (Nasdaq:CELC) has announced the recruitment of two senior executives, Michael Snitkovsky as VP of Program Management and David Bridge as VP of Quality Assurance and Process Development. Michael brings over 15 years of drug development experience, while David has a solid background in quality assurance compliance. Their expertise is expected to strengthen Celcuity's leadership and enhance its clinical development initiatives, particularly aimed at improving cancer patient outcomes through innovative therapies and companion diagnostics.
Celcuity Inc. (NASDAQ:CELC) has entered into a clinical trial collaboration and supply agreement with Pfizer to provide Ibrance® (palbociclib) at no cost for its upcoming Phase 3 clinical trial aimed at treating ER+/HER2- advanced breast cancer. The trial will evaluate the efficacy of gedatolisib combined with palbociclib and Faslodex® (fulvestrant). Anticipated initiation is in the first half of 2022. Positive outcomes from a Phase 1b trial indicate potential for addressing unmet needs in treatment options for patients who have progressed on their first-line therapy.
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