Sun Pharma & Philogen Resubmit Nidlegy MAA to EMA

SIENA, Italy & MUMBAI, India — Italian biotechnology company Philogen S.p.A. and India’s Sun Pharmaceutical Industries Limited have officially resubmitted the Marketing Authorization Application (MAA) for Nidlegy™ to the European Medicines Agency (EMA). The filing seeks approval for Nidlegy™ as a neoadjuvant (pre-surgical) treatment for adult patients suffering from locally advanced, fully resectable melanoma.

This regulatory milestone restores the candidate to active review after a voluntary withdrawal in June 2025. The updated filing incorporates extended 33-month follow-up clinical data and resolves outstanding Chemistry, Manufacturing, and Controls (CMC) inquiries previously identified by European regulators.

Technical Background and Clinical Trial Foundation

Nidlegy™ is a proprietary biopharmaceutical combination comprising two active immunocytokines: bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). Manufactured independently and combined immediately prior to intralesional injection, the treatment is designed to target the Extra Domain B of Fibronectin—a protein expressed predominantly in tumor tissue while remaining absent in most healthy organs.

The submission relies primarily on findings from the Phase III PIVOTAL trial, an international, randomized, parallel-group study evaluating 256 adult patients with locally advanced melanoma. In the study, patients receiving neoadjuvant intralesional injections of Nidlegy™ prior to surgery demonstrated a statistically significant 41% reduction in the risk of disease relapse or death compared to those receiving standard surgical resection alone.

Regulatory Trajectory and CMC Resolution

The initial MAA for Nidlegy™ was validated by the EMA in June 2024. However, in June 2025, Philogen voluntarily withdrew the dossier to gather additional data requested by the EMA’s Committee for Medicinal Products for Human Use (CHMP) regarding manufacturing quality standards and long-term efficacy parameters.

The July 2026 resubmission addresses these regulatory gaps by supplying comprehensive technical responses to past CMC queries and incorporating mature 33-month follow-up data from the PIVOTAL trial.

Commercial Framework and Industry Impact

Under an exclusive licensing agreement executed in May 2023, Sun Pharma holds commercialization rights for skin cancer indications of Nidlegy™ in Europe, Australia, and New Zealand. Philogen retains rights in other territories and underlying intellectual property.

Post-commercialization revenues and economics across the licensed territories will be shared equally on a 50:50 basis. If approved by the EMA, Nidlegy™ would become the first immunocytokine therapy approved in Europe for neoadjuvant treatment of locally advanced melanoma.

Official Sources Section

According to regulatory filings and joint statements issued by Sun Pharmaceutical Industries Limited and Philogen S.p.A., the resubmitted marketing dossier fulfills the scientific and technical criteria outlined by European authorities during prior procedural meetings. Updates were formally published through official company communications and stock exchange filings.

Official Statements and Industry Perspective

According to company officials, the resubmission represents a pivotal step in expanding therapeutic options for skin cancer patients facing high recurrence risks.

In official statements issued regarding the therapeutic pipeline, executive leadership noted:

"Our group is committed to working closely with the European Medicines Agency throughout the review process with the goal of making Nidlegy™ available to patients in need."

Why It Matters

Locally advanced melanoma presents a high risk of local recurrence and distant metastasis, even after successful surgical resection. Current standard-of-care options often leave patients vulnerable to disease progression.

If authorized, Nidlegy™ will provide oncologists with a targeted, pre-surgical intervention designed to boost systemic antitumor immunity locally before surgical intervention. For healthcare providers and patients across Europe, it introduces a novel mechanism of action in onco-dermatology. For investors, it reinforces Sun Pharma's expansion into high-margin specialty oncology assets.

Key Facts at a Glance

• Therapeutic Candidate: Nidlegy™ (bifikafusp alfa / onfekafusp alfa immunocytokine combination).

• Indication: Neoadjuvant treatment for adult patients with locally advanced, fully resectable melanoma.

• Clinical Trial Benchmark: Phase III PIVOTAL trial showed a 41% reduction in relapse or death risk vs. surgery alone.

• Regulatory Timeline: Originally submitted June 2024, withdrawn June 2025, and resubmitted July 2026 with 33-month follow-up data.

• Commercial Agreement: 50:50 economic partnership between Philogen and Sun Pharma covering Europe, Australia, and New Zealand.

Frequently Asked Questions (FAQ)

What is Nidlegy™ and how is it administered?

Nidlegy™ is a biopharmaceutical medicine consisting of two active ingredients (L19IL2 and L19TNF). It is administered via direct intralesional injection into skin lesions prior to surgical removal.

Why was the original application withdrawn in 2025?

Philogen voluntarily withdrew the initial dossier in June 2025 to compile additional manufacturing documentation (CMC) and address questions regarding efficacy endpoint definitions required by the EMA.

What new data was included in the resubmission?

The updated July 2026 dossier contains 33 months of mature clinical follow-up data from the Phase III PIVOTAL trial and resolved technical CMC responses requested by regulators.

Who will market Nidlegy™ if approved in Europe?

Sun Pharmaceutical Industries Limited holds exclusive commercialization rights for skin cancer indications in Europe, Australia, and New Zealand under a 50:50 economic sharing arrangement with Philogen.

Source: Official regulatory press releases and regulatory disclosures from Sun Pharmaceutical Industries Limited, Philogen S.p.A., and the European Medicines Agency (EMA).