Philogen Resubmits Updated Marketing Authorization Application for Nidlegy in Melanoma to EMA

Philogen Resubmits Updated Marketing Authorization Application for Nidlegy in Melanoma to EMA​

Siena, Italy (27 July 2026) A major update has been announced regarding Nidlegy™, the investigational product developed by Philogen S.p.A., as it is resubmitted to the European Medicines Agency (EMA). The updated Marketing Authorization Application (MAA) concerns approval for Nidlegy™ in the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma.

The submission follows previous communications from Philogen and incorporates significant updates based on clinical data from the randomized Phase III PIVOTAL study (NCT02938299). The updated dossier features a longer median patient follow-up period of 33 months, compared to the 21 months reported in the June 2024 MAA. It also includes additional posthoc analyses focused on event-free survival.

The clinical data supporting the initial submission were published in Annals of Oncology (Kähler et al., Annals of Oncology, 2025). The new data forming the basis of this resubmission have been accepted for publication in the Journal of Clinical Oncology and are anticipated to be published online in the coming weeks.

In the PIVOTAL study, Nidlegy™ demonstrated a reduction in the risk of relapse or death compared to the control arm, with its safety profile primarily characterized by low-grade, local adverse events. The updated application also contains additional Chemistry, Manufacturing and Controls (CMC) information designed to address outstanding questions raised during the previous review process.

Comprehensive Data Supporting Resubmission​

Beyond the PIVOTAL study findings, the resubmission includes supporting data from several other studies:

• Phase II Study: PH-L19IL2TNF-02/12 (NCT02076633) efficacy and safety data.
• Ongoing Phase III Study: PHL19IL2TNF-01/18 (NCT03567889), providing additional safety data.
• Phase II Study: PH-L19IL2TNFNMSC-04/19 (NCT04362722), focusing on non-melanoma skin cancer.

Prof. Dr Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, stated that the company is committed to advancing Nidlegy™ in melanoma and non-melanoma skin cancers. He noted that his team has intensively worked to address the clinical and CMC questions raised during the review process while continuing to expand the global Phase III NeoDREAM study.

About Nidlegy™ and its Trials​

Nidlegy™ is a biopharmaceutical product developed by Philogen for the treatment of skin cancer, consisting of two active ingredients: L19IL2 and L19TNF. These components are manufactured independently and then mixed prior to intralesional administration. The L19 antibody targets the Extra Domain B of Fibronectin, a protein found in tumors but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) function as pro-inflammatory cytokines with potent anti-tumor activity.

Nidlegy™ is currently being investigated across multiple trials:

• Locally Advanced Melanoma: The PIVOTAL study enrolled 256 patients across 22 centers in Germany, Italy, France, and Poland, evaluating Nidlegy™ as a neoadjuvant treatment before surgery (up to four injections, once a week). This melanoma is defined as a metastatic cancer that has spread to regional lymph nodes or can appear as satellite/in transit metastases.
• Non-Melanoma Skin Cancers: The product is also in Phase II clinical trials for High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

Sun Pharmaceutical Industries Limited is partnered with Philogen to support the treatment of Skin Cancers in Europe, New Zealand, and Australia.

SUNPHARMA Stock Price Movement​

Today, shares of Sun Pharmaceutical Industries Limited rallied, settling at ₹1973.70 in post-market trading after surging 1.64%. The stock achieved a 52-week high, as the equity traded amidst a volume of 5.41 million shares.