Sun Pharmaceutical Industries Limited has informed the Exchange regarding a press release dated Jun 24, 2025, titled "Update on Marketing Authorization Application for Nidlegy in the European Union".
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Sun Pharma's partner Philogen S.p.A has voluntarily withdrawn its Marketing Authorization Application (MAA) for Nidlegy™, a skin cancer treatment that Sun Pharma has partnered for Europe, New Zealand, and Australia. The withdrawal from the European Medicines Agency (EMA) was due to the inability to provide required Chemistry Manufacturing Controls (CMC) and additional clinical data within the current allowed timeframe. Nidlegy™ had shown strong Phase 3 PIVOTAL study results, reducing relapse or death risk by 41% versus control in 256 patients with locally advanced fully resectable melanoma. Philogen plans to resubmit the MAA with updated data and remains confident in the drug's benefit-risk profile. The drug targets an area where no approved neoadjuvant treatment currently exists.
This is a regulatory delay rather than a rejection—Philogen intends to resubmit, so the drug's long-term commercial potential is intact. For Sun Pharma shareholders, this pushes back the potential European launch timeline of Nidlegy™ but has limited impact on near-term financials since the product is still in development and not yet a revenue contributor.