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) 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.
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on cancer treatment, will have its CEO Brian Sullivan participate in virtual investor meetings at two upcoming conferences. The 12th Annual Craig-Hallum Alpha Select Conference is scheduled for November 16, 2021, followed by the Jefferies London Healthcare Conference on November 18-19, 2021. Celcuity utilizes a unique CELsignia companion diagnostic platform to identify patients who could benefit from targeted therapies by analyzing live tumor cells.
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