European Medicines Agency validates submission of MAA for Nidlegy

Philogen S.p.A. and Sun Pharmaceutical Industries announced that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy , which was finalized on 03 June 2024.

Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. Both companies jointly made the following announcements: - 23 October 2023 - Phase III PIVOTAL trial met the primary endpoint

- 31 May 2024 - Primary results of PIVOTAL presented at ASCO

- 04 June 2024 - MAA submission to EMA

The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024.

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