Olema Oncology Shares Ascend As FDA Grants Fast Track Status To Breast Cancer Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Olema Oncology’s OLMA lead asset OP-1250 for the treatment of ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer.

OP-1250 is currently being evaluated in an ongoing Phase 1/2 clinical trial and in Phase 1b combination with palbociclib in patients with recurrent, locally advanced, or metastatic ER+/HER2- breast cancer.

Sean P. Bohen, President and Chief Executive Officer, commented : "Receiving Fast Track designation from the FDA for OP-1250 is an important milestone for the development program and underscores OP-1250's potential clinical utility to address a significant unmet medical need in women living with advanced ER+/HER2- breast cancer. We look forward to working closely with the FDA to optimize and expedite the development program, with the goal of making OP-1250 available to patients sooner."

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action : Olema shares are trading around 10 percent higher at $5.16 on Thursday during pre-market session.