Sun Pharma Shares in Focus After Nidlegy Application Withdrawal

On June 25, 2025, Sun Pharma shares are on investors’ radar after announcing a regulatory setback involving one of its key pipeline therapies.

Nidlegy Application Withdrawn from EMA

Sun Pharma’s European biotech partner, Philogen, has voluntarily withdrawn the Marketing Authorisation Application (MAA) for Nidlegy, an experimental biologic therapy, from the European Medicines Agency (EMA). The decision, according to the company, stems from timing issues related to the availability of critical supporting data.

About Nidlegy: A Melanoma Therapy

Nidlegy is being developed as a neoadjuvant treatment for adults with locally advanced, resectable melanoma. The product has been administered to over 450 patients across various forms of skin cancer, suggesting its strong potential in oncological therapy.

The therapy is co-developed by Sun Pharma and Philogen, targeting key international markets including Europe, Australia, and New Zealand.

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Why the Application Was Pulled?

The MAA was originally submitted in June 2024. However, Philogen stated that delays in providing essential Chemistry, Manufacturing and Controls (CMC) data and additional clinical information meant that they could not meet EMA’s current regulatory timelines. These data are necessary to fully establish the therapy’s benefit-risk profile.

Next Steps: Resubmission Planned

"After careful consideration of the feedback and ongoing dialogue with EMA, we have decided to withdraw the MAA for Nidlegy and resubmit an updated application, in view of the potential of the product in melanoma and beyond. We are working closely together with EMA to address their requests in preparation of the forthcoming resubmission of the MAA," said Prof. Dr. Dario Neri, CEO and CSO, Philogen.

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