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. (Nasdaq: CELC) is a cutting-edge biotechnology company committed to developing targeted therapies for oncology. The company's proprietary functional cellular analysis platform offers a unique approach to personalized medicine by assessing the functionality of disease-related signaling pathways directly from a patient's diseased cells ex vivo. This innovative technology provides specific insights into how effectively a drug therapy impacts a patient's tumor cells, thereby transforming the treatment paradigm.
Celcuity's lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that targets all Class I PI3K isoforms and mTOR. Gedatolisib exhibits a highly differentiated mechanism of action and pharmacokinetic properties compared to other approved and investigational therapies that focus on PI3K or mTOR pathways individually or together. The company is actively pursuing multiple clinical trials to explore the efficacy of gedatolisib in various oncology indications.
Currently, Celcuity is enrolling patients for its Phase 3 VIKTORIA-1 clinical trial, which evaluates gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer. The Phase 1b/2 clinical trial (CELC-G-201) is assessing gedatolisib in combination with darolutamide for treating metastatic castration-resistant prostate cancer (mCRPC).
In recent preclinical studies, gedatolisib has been shown to be more effective than single node PAM inhibitors in controlling crucial cellular functions necessary for cancer cell survival and proliferation. These promising results underline the potential of gedatolisib as a transformative treatment option for multiple solid tumor indications.
Celcuity has also announced the initiation of the Phase 3 VIKTORIA-2 clinical trial, which will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer in patients who are endocrine therapy resistant. The trial is expected to start enrolling patients in the second quarter of 2025 and aims to add significant value to existing treatment protocols.
Celcuity's financial health is robust, supported by recent equity placements and a substantial debt facility agreement, which provides adequate capital to fund their operational activities into 2026. Further information about Celcuity, its pipeline, and ongoing clinical trials can be found on their official website.
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.
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.
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