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FDA grants priority review to Aicuris' pritelivir for refractory herpes in immunocompromised patients

Company Fundamentals
16 Apr 2026
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Bullish
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The FDA has granted Priority Review to Aicuris' New Drug Application for pritelivir, a novel treatment for refractory herpes simplex virus infections in immunocompromised patients. Phase 3 trial data showed pritelivir significantly improves lesion healing and reduces viral load compared to current therapies, with a favorable safety profile. The FDA's Prescription Drug User Fee Act (PDUFA) target date is set for Q4 2026. If approved, pritelivir would be the first new herpes treatment in over 20 years, addressing a critical unmet need in vulnerable patients.

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