Alnylam Submits Regulatory Application To European Medicines Agency For Vutrisiran To Treat ATTR Amyloidosis With Cardiomyopathy; Submission Based On HELIOS-B Phase 3 Results Showing Significant Reduction In Death And Cardiovascular Events
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Alnylam Pharmaceuticals has submitted a regulatory application to the European Medicines Agency for Vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy. This submission is based on positive Phase 3 results from the HELIOS-B study, which showed a significant reduction in death and cardiovascular events.
October 16, 2024 | 12:12 pm
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POSITIVE IMPACT
Alnylam Pharmaceuticals has submitted Vutrisiran for regulatory approval in Europe, based on successful Phase 3 trial results. This could lead to expanded market access and increased revenues if approved.
The submission of Vutrisiran to the EMA is a significant step for Alnylam, as it could lead to approval and market access in Europe. The positive Phase 3 results enhance the likelihood of approval, which would potentially increase the company's revenues and market presence.
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