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UniQure Q1 Earnings Review: Limited Progress With FDA, But UK Approval In Play
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UniQure Q1 Earnings Review: Limited Progress With FDA, But UK Approval In Play

Seeking Alpha·Edmund Ingham·21 days ago
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Home Earnings Analysis Healthcare  Summary UniQure is upgraded from Hold to Buy, driven by near-term UK approval prospects for AMT-130 and a robust cash runway to 2029. Despite FDA requiring a new Phase 3 trial for AMT-130 in Huntington's, a UK submission is imminent, positioning QURE for a major catalyst. QURE’s pipeline, including AMT-260 for epilepsy and AMT-191 for Fabry, offers additional upside, though AMT-162 was discontinued. With potential UK approval, $750m peak annual revenue by 2030 is projected, and QURE’s valuation could trend toward $3bn if milestones are met. It will additionally be intriguing to see if high-profile departures at the FDA, plus updated four-year data from a Phase 1/2 study, soften the FDA's stance on approval. Looking for a helping hand in the market? Members of Haggerston BioHealth get exclusive ideas and guidance to navigate any climate.…

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