Benzinga | Sep 21, 2021 04:35PM EDT

Summit Therapeutics Recent 8-K Shows Co. Received Feedback From FDA That Agency 'does not agree with the change to the primary endpoint that Summit proposed and has subsequently implemented in its ongoing Phase III Ri-CoDIFy studies...'

Summit Therapeutics Inc. ("Summit") received feedback from the United States Food and Drug Administration (the "FDA") that the FDA does not agree with the change to the primary endpoint that Summit proposed and has subsequently implemented in its ongoing Phase III Ri-CoDIFy studies when combining the studies. As Summit previously communicated, it has combined the Phase III studies into a single study and will provide the combined results to all stakeholders, as the top line results become available. These top line results will best inform all parties as to the next appropriate course of action regarding ridinilazole. Summit anticipates communicating these results during the first quarter of 2022.