KBC Securities - Hyloris Pharmaceuticals (HYL) Hyloris Valacyclovir oral suspension is delayed

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KBC Securities

Mathijs Geerts Danau

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.

19/02/2026 1 EN

Underlying

Hyloris Pharmaceuticals

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BE0974363955 Euronext Brussels Belgium

Provider

KBC Securities

We are a financial services provider for several types of professional clients, each with distinct needs.

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Analysts

Mathijs Geerts Danau

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Hyloris Valacyclovir oral suspension is delayed

We are a financial services provider for several types of professional clients, each with distinct needs.

Morning Notes : ABI BB, AGN NA, ARCAD NA, BESI NA, ENX FP, GIMB BB, HYL BB, IBAB BB, KIN BB, MTLS US, VGP BB, AZE BB, ZEAL DC

Morning Notes : ARCAD NA, GIMB BB, HYL BB, CTPNV NA

VGP FY25 results come a bit short, a new JV partner compensates

Materialise FIRST LOOK : 4Q25 results

Zealand Pharma FY25 results: Looking forward to petrelintide phase 2 data

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