FX.co ★ Olema: FDA Clears Investigational New Drug Application For OP-3136; Trial To Initiate In Early 2025

Olema Pharmaceuticals (OLMA) has announced that the FDA has approved the Investigational New Drug application for OP-3136. This small molecule, which powerfully and selectively inhibits KAT6—a validated epigenetic target disrupted in breast and other cancers—will soon enter clinical trials. The company plans to begin the Phase 1 clinical trial early next year.

"We are thrilled to have received the go-ahead from the FDA to advance OP-3136 into clinical settings," remarked David Myles, Olema Oncology's Chief Discovery and Non-Clinical Development Officer.