Sun Pharma Partner Philogen Resubmits Nidlegy MAA to EMA

Date: 27 July 2026

About Nidlegy™

Nidlegy™ is a biopharmaceutical product consisting of two active ingredients: L19IL2 and L19TNF. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with potent anti-tumor activity.

Nidlegy™ is currently being investigated in:

• Two Phase III clinical trials for locally advanced melanoma
• Phase II clinical trials for High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers

Management Commentary

Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, commented: "Philogen remains fully committed to advancing Nidlegy™ in melanoma and non-melanoma skin cancers. Since the previous MAA procedure, our team has worked intensively to address the clinical and CMC questions raised during the review. In parallel, we have continued to expand the global Phase III NeoDREAM melanoma study and have launched additional registrational studies in non-melanoma skin cancers."