Sun Pharmaceutical Industries Limited — Updates, 24-06-2025: Press Release

Sun Pharma’s partner Philogen has withdrawn the marketing authorization application for Nidlegy™ in the EU due to delays in providing manufacturing and additional clinical data. Nidlegy™, targeted at locally advanced fully resectable melanoma, demonstrated a 41% reduction in relapse or death risk in a Phase 3 study with a tolerable safety profile. Philogen remains confident in Nidlegy’s potential and plans to resubmit the application after addressing regulatory feedback, aiming to make the drug available for melanoma and other skin cancers soon.