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, a clinical-stage biotechnology company, announced significant milestones, including dosing the first patient in the Phase 3 VIKTORIA-1 trial for gedatolisib, leading to a $100 million PIPE financing and a $20 million term loan. These funds extend cash runway into 2025. The company reported a net loss of $11.6 million for Q4 2022, increasing from $6.8 million in Q4 2021, with full-year losses of $40.4 million. Total operating expenses for Q4 were $11.6 million, up from $6.3 million the previous year. However, cash reserves at year-end stood at $168.6 million, ensuring operational stability for upcoming trials.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, will announce its fourth quarter and full year 2022 financial results on March 23, 2023, after market close. A webcast and teleconference will follow at 4:30 p.m. Eastern Time for discussion. The company is focused on developing targeted therapies for oncology, with its leading candidate, gedatolisib, currently in a Phase 3 clinical trial for HR+/HER2- advanced breast cancer. The VIKTORIA-1 trial is enrolling patients and represents a key development for Celcuity. More details can be found on ClinicalTrials.gov.
Celcuity Inc. (NASDAQ: CELC) announced the publication of preclinical data on gedatolisib, a pan-PI3K/mTOR inhibitor, demonstrating significant therapeutic effects against endometrial, ovarian, and cervical cancer cell lines. This data will be presented at the 2023 AACR Annual Meeting on April 18, 2023. The study showcases gedatolisib's efficacy through cell viability, proliferation, and flow cytometry assays, emphasizing its differentiated mechanism. The ongoing Phase 3 trial, VIKTORIA-1, is currently enrolling patients for HR+/HER2- advanced breast cancer. These results support further clinical development plans for gedatolisib.
MINNEAPOLIS, MN / ACCESSWIRE / March 1, 2023 / Celcuity (NASDAQ:CELC), a biotechnology company focused on oncology therapies, will participate in Cowen's 43rd Annual Health Care Conference in Boston from March 6-8, 2023. CEO Brian Sullivan is scheduled to present on March 8 at 11:10 a.m. ET. The presentation will be available via live webcast at this link and can also be accessed through the company's Investors section. Celcuity's lead candidate, gedatolisib, is currently being evaluated in a Phase 3 trial for advanced breast cancer.
Celcuity Inc. (NASDAQ:CELC) presented promising preclinical data on gedatolisib at the ASCO Genitourinary Cancers Symposium on February 16, 2023. Gedatolisib showcased superior potency and efficacy in treating prostate cancer cell lines, outperforming other PI3K/AKT/mTOR inhibitors, regardless of PI3K or PTEN status. This suggests its potential to overcome resistance to androgen receptor inhibitors in metastatic castration-resistant prostate cancer (mCRPC). The investigational drug is part of ongoing Phase 1b and Phase 3 clinical trials aimed at advanced breast cancer and solid tumors, respectively. Results imply a significant advancement in targeted cancer therapies.
Celcuity Inc. (NASDAQ:CELC) has successfully closed a private placement yielding approximately $100 million in gross proceeds. This event correlates with the initiation of the Phase 3 clinical trial, VIKTORIA-1, which tests its leading drug, gedatolisib. The funding will support operational needs through 2025 and enable a draw of $20 million from an existing debt facility. Led by Venrock Healthcare Capital Partners and other investors, the private placement includes shares sold at $5.75 each and warrants at a premium. Further details on securities registration are forthcoming.
Celcuity Inc. (Nasdaq: CELC) presented encouraging updates from its Phase 1b trial of gedatolisib for advanced breast cancer at the 2022 San Antonio Breast Cancer Symposium. High response rates were found, with a median progression-free survival (PFS) of 42.3 months for treatment-naïve patients. Efficacy was noted regardless of PIK3CA mutation status, with an overall response rate (ORR) of up to 85%. Celcuity plans further evaluation of gedatolisib combined with CDK4/6 inhibitors and endocrine therapy in future trials, highlighting its unique mechanism of action.
Celcuity Inc. (Nasdaq:CELC) has announced the dosing of its first patient in the Phase 3 clinical trial, VIKTORIA-1, which is testing gedatolisib for HR+/HER2- advanced breast cancer. This milestone enables the closing of a $100 million PIPE financing and draws down a $20 million term loan. Gedatolisib is designed to provide better treatment options for patients whose cancer progressed under previous therapies. The FDA has granted Breakthrough Therapy status to gedatolisib, signaling promising prospects for faster regulatory review.
Celcuity Inc. (NASDAQ:CELC) announced that an abstract for a Spotlight Poster presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website. The event occurs from December 6-10, 2022. The presentation will showcase updated efficacy and safety data from a Phase 1b study of gedatolisib and palbociclib in women with advanced breast cancer, highlighting promising results regardless of PIK3CA mutation status. Notably, treatment-naïve patients showed an objective response rate (ORR) of 85%.
Celcuity Inc. (NASDAQ:CELC) announced CEO Brian Sullivan's participation in one-on-one and small group meetings at the 13th Annual Craig-Hallum Alpha Select Conference on November 17, 2022, in New York. The clinical-stage biotechnology company focuses on developing targeted therapies for various cancers, with gedatolisib as its lead candidate. Gedatolisib is currently evaluated in the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer. The company also utilizes its CELsignia companion diagnostic platform to identify potential patients for targeted therapies.
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