The latest update is out from Hyloris Pharmaceuticals SA ( (DE:52U) ).
Hyloris Pharmaceuticals announced that the FDA has accepted their New Drug Application for Valacyclovir oral suspension, setting a target action date of October 12, 2025. This development marks a significant milestone for the company, potentially enhancing patient compliance by offering a more convenient form of an existing therapy for herpes virus infections. The acceptance is supported by data from pivotal clinical trials, indicating comparable bioavailability to existing tablet forms. This advancement could strengthen Hyloris’ position in the market by addressing unmet medical needs and improving treatment adherence.
More about Hyloris Pharmaceuticals SA
Hyloris Pharmaceuticals SA is a specialty biopharma company based in Liège, Belgium, focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs. The company leverages established regulatory pathways to reduce clinical burdens and shorten development timelines, aiming to deliver improvements for patients, healthcare professionals, and payors. Hyloris has a broad portfolio of reformulated and repurposed medicines, with some products in early commercialization phases.
YTD Price Performance: -28.01%
Average Trading Volume: 424
Technical Sentiment Consensus Rating: Buy
Current Market Cap: €147.8M
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