KENILWORTH (NJ) (dpa-AFX) - Merck & Co., Inc. (MRK), Friday announced that the company has secured conditional marketing authorization from the European Commission for EZMEKLY for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric and adult patients with neurofibromatosis type 1 aged 2 years and above.
The approval is based on data from the ongoing, multi-center, open-label, single arm Phase 2b ReNeu trial, which met the primary endpoint of confirmed objective response rate, demonstrating an ORR of 41 percent in adults and 52 percent in children.
Moreover, EZMEKLY demonstrated an encouraging efficacy and safety profile in both adults and children during the clinical trials.
Currently, MRK is trading at $80.61, down 1.12 percent on the New York Stock Exchange.
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