Report
Hyloris Valacyclovir oral suspension is delayed
Hyloris provided an update regarding the review of valacyclovir for oral suspension which had a PDUFA target action date of 12 October 2025. It appears that the FDA identified significant inspection observations at the third party manufacturing plant in Greece. The manufacturer confirmed that it is actively implementing its remediation plans. Currently, Hyloris believes that resolution of the manufacturing situation is required to obtain an FDA product approval and is working on a solution. We reiterate our € 6 TP and Hold rating.
Underlying
Hyloris Pharmaceuticals
Provider
KBC Securities
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Mathijs Geerts Danau
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