Sun Pharmaceutical Industries partner Philogen S.p.A. resubmitted the Marketing Authorization Application (MAA) for Nidlegy™ to the European Medicines Agency (EMA) on July 27, 2026. The updated dossier targets the neoadjuvant treatment of locally advanced, fully resectable melanoma and incorporates extended clinical follow-up data, addressing previous regulatory queries. This development advances the potential approval of the therapy in Europe, where Sun Pharma holds partnership rights alongside New Zealand and Australia.

The resubmission relies primarily on data from the randomized Phase III PIVOTAL study (PH-L19IL2TNF-02/15; NCT02938299). Compared to the initial MAA filed in June 2024, the new submission extends the median patient follow-up period from 21 months to 33 months. It also includes additional post-hoc analyses focused on event-free survival. The clinical data supporting this update have been accepted for publication in the Journal of Clinical Oncology (doi 10.1200/JCO-26-00852) and are expected to appear online shortly.

In the PIVOTAL study, Nidlegy™ demonstrated a reduced risk of relapse or death compared to the control arm. The safety profile was characterized predominantly by low-grade, local adverse events. The updated application also provides additional Chemistry, Manufacturing and Controls (CMC) information intended to resolve outstanding questions raised during the previous review procedure.

Supporting Clinical Data

Beyond the PIVOTAL study, the dossier includes efficacy and safety data from the Phase II study PH-L19IL2TNF-02/12 (NCT02076633). It further incorporates safety data from the ongoing Phase III NeoDREAM study (PH-L19IL2TNF-01/18; NCT03567889) and safety data from the Phase II study PH-L19IL2TNFNMSC-04/19 (NCT04362722) in non-melanoma skin cancer.

Partnership and Regulatory Context

Nidlegy™ is a biopharmaceutical product proprietary to Philogen, consisting of two active ingredients: L19IL2 and L19TNF. These are manufactured independently and mixed prior to intralesional administration. The L19 antibody targets Extra Domain B of Fibronectin, a protein expressed in tumors but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) provide potent anti-tumor activity.

Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, stated that the company remains fully committed to advancing Nidlegy™ in melanoma and non-melanoma skin cancers. He noted that the team has worked intensively since the previous MAA procedure to address clinical and CMC questions raised during the review. In parallel, Philogen has expanded the global Phase III NeoDREAM melanoma study and launched additional registrational studies in non-melanoma skin cancers.

Sun Pharmaceutical Industries disclosed the update under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The filing confirms that Philogen’s submission follows previously communicated timelines.

sun pharmaceutical Industries Ltd. recorded a notable block trade on the National Stock Exchange (NSE), with the transaction valued at ₹438.09 crores. The deal involved approximately 2,242,462 shares, executed at a price of ₹1953.60 per share, highlighting significant institutional-level activity in the counter.

Block Trade Details

The following table summarizes the key parameters of the block trade recorded on the NSE:

Block trades are large, privately negotiated transactions that are executed outside the open market to minimize price impact. Such trades are commonly associated with institutional investors, including mutual funds, foreign portfolio investors, or other large market participants, transacting in substantial quantities of shares.