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The FDA's call for another trial indicates regulatory uncertainty, negatively affecting investor confidence. Historical cases show similar FDA mandates often lead to price declines.
What happened, with direct paths to the underlying reporting
FDA requires confirmatory Phase 3 trial for apraglutide approval. Ironwood engaged Goldman Sachs to explore strategic alternatives. Strong efficacy data from STARS trial but lower than expected doses. Completion of NDA submission expected by Q3 2025. IRWD stock dropped 30.28% to 66 cents.
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