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. develops targeted oncology therapies as a clinical-stage biotechnology company, with news centered on gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor for solid tumors. Company updates frequently cover Phase 3 VIKTORIA-1 data in HR+/HER2- advanced breast cancer, including PIK3CA wild-type and mutant cohorts and combination regimens with fulvestrant and palbociclib.
Recurring announcements also address FDA regulatory submissions and review status for gedatolisib, publications and medical-meeting presentations, quarterly financial results, corporate updates, investor conference participation, and board governance changes.
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Celcuity Inc. (Nasdaq:CELC) recently presented preclinical studies on gedatolisib, a pan-PI3K and mTOR inhibitor, showcasing its enhanced anti-tumor efficacy in gynecological cancer models, including endometrial, ovarian, and cervical cancers. The data, revealed at the 2023 AACR Annual Meeting, indicate gedatolisib outperformed other PAM inhibitors irrespective of mutational status, demonstrating significant tumor growth inhibition in vivo. The findings suggest gedatolisib's potential across various solid tumors, reinforcing its differentiated mechanism of action. Currently, a Phase 3 trial, VIKTORIA-1, is ongoing to further evaluate gedatolisib's effectiveness in treating HR+/HER2- advanced breast cancer. These developments highlight the investigational drug's promising profile and potential market impact in oncology.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, will participate in the 22nd Annual Needham Virtual Healthcare Conference on April 19, 2023. Brian Sullivan, the company's CEO, is scheduled to present at 1:30 p.m. ET. The presentation can be accessed via a live webcast linked here or through the company's Investors section, where a replay will also be available afterwards.
Celcuity's lead candidate, gedatolisib, is designed to target multiple solid tumors and is currently in a Phase 3 trial (VIKTORIA-1) for HR+/HER2- advanced breast cancer. The company's CELsignia platform analyzes live patient tumor cells to identify cancer patients who may benefit from existing therapies. For more information, visit Celcuity.com.
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.