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FDA/Panel Decisions

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

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Olema Pharmaceuticals (OLMA) announced the FDA has cleared Investigational New Drug application for OP-3136, a small molecule that potently and selectively inhibits KAT6, a validated epigenetic target that is dysregulated in breast and other cancers. The company expects to initiate the Phase 1 clinical trial early next year.

"We are very pleased to have received notification from the FDA that OP-3136 may proceed into the clinic, said David Myles, Chief Discovery and Non-Clinical Development Officer of Olema Oncology.

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