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Philogen Withdraws Nidlegy™ Application, Plans Resubmission

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Philogen Withdraws Nidlegy™ Application, Plans Resubmission

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An update from Sun Pharmaceutical Industries Limited ( (IN:SUNPHARMA) ) is now available.

Philogen S.p.A, in partnership with Sun Pharmaceutical Industries Limited, has announced the withdrawal of its marketing authorization application for Nidlegy™, a treatment for locally advanced fully resectable melanoma, from the European Medicines Agency (EMA). The decision was made due to the timing of additional data required to better characterize the product’s benefit-risk profile. Despite this setback, Philogen remains optimistic about Nidlegy™’s efficacy and safety, and plans to resubmit an updated application. The withdrawal may delay the product’s availability but underscores the commitment to ensuring comprehensive data supports its approval, impacting stakeholders and the market positioning of both Philogen and Sun Pharma.

More about Sun Pharmaceutical Industries Limited

Sun Pharmaceutical Industries Limited operates in the pharmaceutical industry, focusing on the development and manufacturing of pharmaceutical formulations and active pharmaceutical ingredients. The company is known for its extensive range of products, including generics, branded generics, specialty, over-the-counter (OTC) products, antiretrovirals (ARVs), APIs, and intermediates. Sun Pharma serves markets across the globe, with a significant presence in India and the United States.

Average Trading Volume: 90,867

Current Market Cap: 3992.4B INR

See more insights into SUNPHARMA stock on TipRanks’ Stock Analysis page.

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