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Summit Therapeutics Down 20% As FDA Do Not Agree To Endpoint Change To Late-Stage Ri-CoDIFy Studies

Shares of Summit Therapeutics Inc. (SMMT) are slipping over 20% on Wednesday morning after the company announced that the U.S. FDA disagreed with its proposed change to the primary endpoint in Phase 3 Ri-CoDIFy studies.

SMMT is currently trading at $5.07, down $1.41 or 21.76%, on the Nasdaq. The stock has traded between $3.15 and $12.30 in the 52 week period.

In an SEC filing, Summit Therapeutics said it received a feedback from the FDA saying that the regulator "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."

In August, Summit said that the two blinded pivotal Phase 3 trials would be combined into a single study. The company plans to provide the results to all stakeholders as the top line results become available, which it expects during the first quarter of 2022.

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