KBC Securities - Hyloris Pharmaceuticals (HYL) Morning Notes : HYL BB

Report

KBC Securities

Hilde Van Boxstael ...

Mathijs Geerts Danau
Wim Lewi

Morning Notes : HYL BB

: HYL BB

30/12/2025 1 EN

Underlying

Hyloris Pharmaceuticals

See profile

BE0974363955 Euronext Brussels Belgium

Provider

KBC Securities

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

See profile

Analysts

Hilde Van Boxstael

Mathijs Geerts Danau

Wim Lewi

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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.

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

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Morning Notes : HYL BB

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

Hyloris Valacyclovir oral suspension is delayed

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

Titan Completion of acquisition of Traçim Cement

Morning Notes : CRBN NA, ELI BB, EXM BB, TWEKA NA, VAN BB, ECMPA NA, ENRGY BB

Van de Velde FIRST LOOK - OK 2H25 but impairment at Top Form

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