Oragenics' ONP-002 Successfully Completes FDA-Required Genotoxicity Studies

OGEN
October 05, 2025

Oragenics, Inc. announced in August 2024 that its lead drug candidate, ONP-002, successfully completed FDA-required genotoxicity testing. These studies confirmed that the drug does not cause DNA damage.

This achievement further strengthens the safety profile of ONP-002 as it advances towards Phase II clinical trials. Demonstrating a lack of genotoxicity is a critical regulatory requirement for drug development.

The successful completion of these safety studies is an important de-risking event for the ONP-002 program. It supports the company's efforts to develop a novel treatment for concussions.

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