Philogen resubmits EMA marketing authorization application for Nidlegy in neoadjuvant melanoma treatment

Reuters2026/07/27 10:02

By:Reuters

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Philogen resubmitted a marketing authorization application to the EMA for Nidlegy in neoadjuvant treatment of resectable locally advanced melanoma.
The filing adds longer Phase III PIVOTAL follow-up of 33 months, up from 21 months in the prior June 2024 submission.
The updated dossier includes additional post-hoc event-free survival analyses, plus expanded CMC information to address previously raised issues.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Philogen S.p.A. published the original content used to generate this news brief via SDIR, the Italian regulatory disclosure system (Ref. ID: 994_170203_2026_oneinfo.pdf), on July 27, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Philogen resubmits EMA marketing authorization application for Nidlegy in neoadjuvant melanoma treatment

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