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Summit Therapeutics Inc (NASDAQ: SMMT) announced that the FDA disagrees with its proposed change to the primary endpoint in Phase 3 Ri-CoDIFy studies.
In a regulatory filing, the Company said that the federal agency does not agree with its proposed change to the primary endpoint implemented in the ongoing trials.
In August, Summit said that the two blinded pivotal Phase 3 trials would be combined into a single study.
The trials were designed to evaluate ridinilazole versus vancomycin for Clostridioides difficile infection.
The trial's primary endpoint seeks to prove ridinilazole's superiority in sustained clinical response compared to vancomycin.
The Company plans to disclose the combined results of the study when topline data become available.
"These topline results will best inform all parties as to the next appropriate course of action regarding ridinilazole," Summit added in the 8-K filing. The topline data from the trial are expected in Q1 2022.
Related content: Benzinga's Full FDA Calendar.
Price Action: SMMT stock dropped 19.7% at $6.48 during after-hours trading on Tuesday.
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