Philogen provides update on marketing authorisation application for Nidlegy in the European Union

Philogen

24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA for Nidlegy, a biological investigational medicinal product which is intended to be used for the neo-adjuvant treatment of adult patients with locally advanced fully resectable melanoma.

The company's decision to withdraw the application was due to the timing of the availability of Chemistry Manufacturing and Controls and additional clinical data to better characterise the benefit:risk profile in patients with locally advanced resectable melanoma.

Read Philogen press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier