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Alnylam Stock Up on Cardiomyopathy Drug Regulatory Filing in the EU

Core Viewpoint - Alnylam Pharmaceuticals has submitted a Type II Variation to the European Medicines Agency for vutrisiran, aimed at treating ATTR amyloidosis with cardiomyopathy, which has positively impacted its stock price [1] Group 1: Company Developments - Vutrisiran is already marketed in the EU under the brand name Amvuttra for hereditary transthyretin-mediated amyloidosis [1] - The application for vutrisiran to treat ATTR-CM is backed by positive results from the HELIOS-B study, which met all primary and secondary endpoints with statistical significance [1][2] - Year-to-date, Alnylam's shares have increased by 57%, contrasting with a 1% decline in the industry [2] Group 2: Product Performance - Amvuttra generated sales of $425.4 million in the first half of 2024, reflecting an 82% year-over-year increase [3] - The growth in Amvuttra sales is attributed to new patient initiations and patients switching from Onpattro [3] - If approved, vutrisiran could become the new standard of care for ATTR-CM, significantly expanding the eligible patient population [4] Group 3: Other Products and Collaborations - Alnylam also markets Givlaari and Oxlumo for other conditions, contributing to its revenue [4] - The company collaborates with Novartis for Leqvio, which is approved for hypercholesterolemia treatment in the EU and the U.S. [5]