Nidlegy marketing authorisation application resubmitted to EMA

Philogen

27 July 2026 - Philogen is pleased to announce the submission of an updated marketing authorisation application to the EMA for the approval of Nidlegy, an investigational product for the neo-adjuvant treatment of adult patients with locally advanced, fully resectable melanoma.

The updated submission is based on clinical data from the randomised Phase 3 PIVOTAL study (PHL19IL2TNF-02/15).

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier , Registration