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 clinical-stage biotechnology company headquartered in Minneapolis and focused on targeted therapies for oncology. News about Celcuity primarily centers on the development of its lead investigational drug, gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) pathway inhibitor being studied in multiple solid tumor indications, including HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
On this page, readers can follow Celcuity’s clinical trial milestones, such as topline and detailed results from the Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA wild-type and mutant advanced breast cancer, as well as updates on the Phase 3 VIKTORIA-2 first-line trial and the Phase 1/2 CELC-G-201 study of gedatolisib plus darolutamide in mCRPC. Company press releases frequently report progression-free survival data, objective response rates, safety outcomes, and subgroup analyses from these studies.
Celcuity’s news flow also includes regulatory and corporate developments, such as the submission of a New Drug Application to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the Real-Time Oncology Review program, participation in major medical meetings like the ESMO Congress and the San Antonio Breast Cancer Symposium, and presentations at healthcare investment conferences. In addition, the company announces financing transactions, including equity offerings, convertible senior notes, and amendments to its term loan facilities that support ongoing clinical and potential commercial activities.
Investors and healthcare professionals can use this news feed to monitor Celcuity’s latest disclosures on gedatolisib’s clinical performance, safety profile, regulatory progress, and capital strategy. Regular updates provide context on how the company’s oncology pipeline is advancing through late-stage development and regulatory review.
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.
Celcuity Inc. (NASDAQ: CELC) reported financial results for Q3 2021, showing a net loss of $6.0 million or $0.41 per share, up from a loss of $2.5 million or $0.24 per share year-over-year. Operating expenses rose to $5.6 million, primarily driven by R&D costs of $5.0 million associated with the gedatolisib program. The company plans to initiate a Phase 3 trial for gedatolisib in early 2022 and update Phase 1b data at the San Antonio Breast Cancer Symposium in December. Cash reserves increased to $90.4 million compared to $11.6 million at year-end 2020.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, announced it will release its third quarter 2021 financial results on November 8, 2021, after the market closes. A webcast and teleconference will follow at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. The company focuses on extending cancer patients' lives through an integrated companion diagnostic and therapeutic strategy, utilizing its CELsignia platform to identify patients likely to benefit from targeted therapies.
Celcuity announced a Phase 2 clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate NERLYNX (neratinib) combined with XELODA (capecitabine) in patients with metastatic HER2-negative breast cancer with brain metastases. The trial, utilizing Celcuity's CELsignia HER2 Activity Test to select patients, aims to find effective treatment options for this underserved group. Interim results are expected within 12-15 months post-enrollment.
Celcuity raised approximately $56.3 million through a follow-on public offering, enhancing its balance sheet to support clinical developments for gedatolisib, a potential first-in-class PI3K/mTOR inhibitor. Following the offering, Celcuity reported $94.4 million in cash on hand. Recent clinical trials showed a promising 65% objective response rate in a Phase 1 study combining gedatolisib with paclitaxel and carboplatin. The company plans to initiate a Phase 2/3 trial for ER+/HER2- metastatic breast cancer in early 2022.