Business
Celcuity Inc. Reports Third Quarter 2021 Financial Results and Provides Corporate Update
On track to obtain FDA feedback and initiate a Phase 3 study for gedatolisib during the first half of 2022Will present updated Phase 1b data during a
About this update from Celcuity Inc.
[{"type":"text","content":"On track to obtain FDA feedback and initiate a Phase 3 study for gedatolisib during the first half of 2022Will present updated Phase 1b data during a Spotlight Poster Discussion Session at the 2021 San Antonio Breast Cancer Symposium in December 2021Entered into clinical trial collaboration with University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate new therapeutic option for metastatic breast cancer patients with brain metastasesManagement to host webcast and conference call today, November 8, 2021, at 4:30 p.m. ET / 1:30 p.m. PTMINNEAPOLIS, MN / ACCESSWIRE / November 8, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced financial results for the third quarter ended September 30, 2021 and summarized recent business progress.\"We made great progress advancing our gedatolisib program this past quarter. We initiated preparation for a Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced or metastatic breast cancer that we expect to activate in the first half of 2022,\" said Brian Sullivan, CEO and co-founder of Celcuity. \"Site identification and feasibility activities are underway. We are excited to have the opportunity to present updated results from our Phase 1b clinical trial in patients with ER+/HER2- advanced breast cancer at the San Antonio Breast Cancer Symposium in December. Finally, we are pleased to have entered into another clinical trial collaboration to evaluate CELsignia® selected patients with advanced breast cancer. The collaboration with University of Rochester Wilmot Cancer Center and Puma represents an important opportunity to identify a potential new treatment for patients with breast cancer that has metastasized to the brain.\"Third Quarter 2021 Business Highlights and Other Recent DevelopmentsCompleted transfer of regulatory, clinical trial, and safety reporting responsibilities for gedatolisib from Pfizer to Celcuity ahead of schedule.Updated data from Celcuity's ongoing Phase 1b clinical trial for patients with ER+/HER2- advanced breast cancer will be presented at the San Antonio Breast Cancer Symposium during a Spotlight Poster Discussion Session on December 10, 2021. Rac...