India's largest drugmaker Sun Pharmaceutical Industries announced that its European biotech partner Philogen has voluntarily withdrawn the marketing authorization application (MAA) for its investigational therapy Nidlegy from the European Medicines Agency (EMA). The decision represents a regulatory setback for the melanoma treatment that had been progressing through European approval processes.
Regulatory Withdrawal Details
The MAA for Nidlegy was originally submitted to the EMA in June 2024. However, Philogen made the strategic decision to withdraw the application due to timing constraints related to the availability of critical regulatory data. Specifically, the company cited delays in providing Chemistry, Manufacturing and Controls (CMC) data and additional clinical information necessary to fully characterize the therapy's benefit-risk profile in patients with locally advanced resectable melanoma.
According to the company, providing this essential data within the current regulatory timeline was deemed unlikely, prompting the voluntary withdrawal to avoid potential regulatory complications.
About Nidlegy Therapy
Nidlegy is a biological investigational medicinal product being developed as a neoadjuvant treatment for adult patients with locally advanced, fully resectable melanoma. The therapy represents a collaborative development effort between Sun Pharma and Philogen, targeting key international markets including Europe, New Zealand, and Australia.
The investigational treatment has demonstrated significant clinical exposure, having been administered to more than 450 patients with various types of skin cancer. This extensive patient experience suggests the therapy's potential utility across multiple skin cancer indications beyond its primary melanoma focus.
Company Response and Future Plans
Prof. Dr. Dario Neri, CEO and CSO of Philogen, addressed the regulatory decision in an official statement: "After careful consideration of the feedback and ongoing dialogue with EMA, we have decided to withdraw the MAA for Nidlegy and resubmit an updated application, in view of the potential of the product in melanoma and beyond. We are working closely together with EMA to address their requests in preparation of the forthcoming resubmission of the MAA."
Philogen emphasized that it remains in close contact with both the EMA and the broader medical community, maintaining its commitment to making Nidlegy available to patients with melanoma and non-melanoma skin cancers as expeditiously as possible. The company has confirmed its intention to resubmit an updated application once the necessary regulatory requirements are fully addressed.
Market Impact
The regulatory setback had minimal immediate impact on Sun Pharma's stock performance, with shares ending 0.15% higher at ₹1,665 on the day of the announcement. However, the stock has experienced broader market pressures, declining 12% in 2025 prior to this development.
The withdrawal, while representing a temporary delay, does not appear to signal fundamental concerns about Nidlegy's therapeutic potential, but rather reflects the complex regulatory requirements for novel cancer therapies in the European market.
