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) 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.
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.
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