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Alnylam Wins EC Nod for Label Expansion of Amvuttra for ATTR-CM
ZACKS· 2025-06-10 14:11
Core Insights - Alnylam Pharmaceuticals has received European Commission approval for the label expansion of its RNAi therapeutic Amvuttra to treat wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy [1][9] - Year-to-date, Alnylam's stock has increased by 29.1%, significantly outperforming the industry, which has seen a decline of 0.9% [2] Approval Details - The European Commission's approval was based on positive results from the late-stage HELIOS-B study, where Amvuttra met all 10 pre-specified primary and secondary endpoints [3][9] - The HELIOS-B trial demonstrated statistically significant reductions in all-cause mortality and recurrent cardiovascular events, along with major improvements in functional capacity, health status, and heart failure symptoms [4][9] Competitive Advantage - Amvuttra is administered quarterly via subcutaneous injection, providing an advantage over existing therapies that require daily oral dosing [5] - The drug's novel RNAi mechanism allows for rapid knockdown of transthyretin (TTR), addressing the disease at its source [6] Market Impact - The approval in the EU follows similar approvals in the United States and Brazil, expanding Amvuttra's global footprint [6] - Alnylam reported better-than-expected first-quarter 2025 results, with revenue growth driven by increasing Amvuttra sales due to heightened patient demand [10][11]
Alnylam Q1 Earnings Beat Estimates, Product Revenues Rise Y/Y
ZACKS· 2025-05-02 15:55
Alnylam Pharmaceuticals (ALNY) reported first-quarter 2025 adjusted loss of 1 cent per share, narrower than the Zacks Consensus Estimate of a loss of 56 cents. The company had incurred a loss of 16 cents per share in the year-ago quarter. The adjusted figure excluded items like stock-based compensation expenses and unrealized loss on marketable equity securities.Alnylam recorded total revenues of $594.2 million in the quarter, which surpassed the Zacks Consensus Estimate of $588.2 million. In the year-ago q ...
Alnylam Pharmaceuticals(ALNY) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:30
Alnylam Pharmaceuticals (ALNY) Q1 2025 Earnings Call May 01, 2025 08:30 AM ET Company Participants Christine Lindenboom - Chief Corporate Communications OfficerYvonne Greenstreet - Chief Executive OfficerTolga Tanguler - Executive VP & Chief Commercial OfficerPushkal Garg - Chief Medical Officer and Executive VP of Development & Medical AffairsJeff Poulton - Chief Financial OfficerGena Wang - MD - Biotech Equity ResearchTeraesa Vitelli - Equity Research AssociateGary Nachman - Managing Director - Equity Res ...
Alnylam Pharmaceuticals(ALNY) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:30
Alnylam Pharmaceuticals (ALNY) Q1 2025 Earnings Call May 01, 2025 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Alnylam Pharmaceuticals Q1 twenty twenty five Earnings Conference Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Thursday, 05/01/2025. I would now like to turn the conference over to Alnylam. Please go ahead. Speaker1 Good morning. I'm Christine Lindenbo ...