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IRWD
Benzinga
127 days

Ironwood Pharmaceuticals Stock Plunges, FDA Wants Another Trial For Gastrointestinal Drug

1. FDA requires confirmatory Phase 3 trial for apraglutide approval. 2. Ironwood engaged Goldman Sachs to explore strategic alternatives. 3. Strong efficacy data from STARS trial but lower than expected doses. 4. Completion of NDA submission expected by Q3 2025. 5. IRWD stock dropped 30.28% to 66 cents.

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FAQ

Why Bearish?

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.

How important is it?

The article outlines critical developments surrounding apraglutide's FDA approval prospects, essential for IRWD's future.

Why Long Term?

The need for additional trials extends the approval timeline, delaying potential revenues and impacting long-term investor outlook.

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