Sun Pharma’s Partner Philogen Withdraws Application for Skin Cancer Drug Nidlegy in Europe

Sun Pharmaceutical Industries, the largest drugmaker in India, stated that its European partner Philogen has opted to withdraw the MAA (marketing authorisation application) for Nidlegy, a proposed skin cancer therapy, from the European Medicines Agency (EMA). 

Why the Application Was Withdrawn

The MAA (marketing authorisation application) for Nidlegy was submitted in June 2024. However, Philogen chose to pull back the application due to delays in providing critical Chemistry, Manufacturing and Controls (CMC) data and additional clinical information. These were essential for assessing the safety and benefits of the drug in treating locally advanced, resectable melanoma. Philogen stated that meeting the EMA’s regulatory timeline was not feasible at this stage.

About Nidlegy and Its Development

Nidlegy is an investigational biologic therapy designed for pre-surgical (neoadjuvant) treatment in adults with skin cancer. Sun Pharma and Philogen are jointly developing it for markets in Europe, New Zealand, and Australia. To date, the therapy has been administered to more than 450 patients with different forms of skin cancer. 

Plans for Resubmission

Despite the setback, Philogen is maintaining dialogue with the EMA and medical professionals and plans to resubmit a revised application. According to Professor Dario Neri, CEO and CSO of Philogen, the decision was made after reviewing EMA’s feedback and assessing the potential of the drug in both melanoma and other skin cancers.

Sun Pharmaceutical Share Price Movement

As of June 26, 2025, Sun Pharmaceutical Industries share price closed at ₹1,666.10, down ₹3.50 or 0.21% from the previous day. The stock opened at ₹1,674.80 and traded between an intraday high of ₹1,678.90 and a low of ₹1,650.40. The company has a market capitalisation of ₹4.00 lakh crore, a P/E ratio of 35.32, and a dividend yield of 0.96%. Its 52-week high and low stand at ₹1,960.35 and ₹1,495.25 respectively. The quarterly dividend amount is ₹4.00 per share.

Also Read: Meesho Becomes an Indian Company, Reshuffles Board Ahead of US$1 Billion IPO! 

Conclusion

While the withdrawal of Nidlegy's application is a temporary hurdle, both Philogen and Sun Pharma remain optimistic. Their focus is now on fulfilling the regulatory requirements and resubmitting the application to bring the potential life-saving therapy to patients as soon as possible.

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