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Friday, Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) stock is trading lower after the company shared detailed results from the HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy (ATTR-CM). Topline data was revealed in June.
The data were presented at the European Society of Cardiology Congress 2024.
In the overall population, vutrisiran reduced the risk of all-cause mortality and recurrent cardiovascular events by 28%, with similar reductions in the mortality and cardiovascular events components of the endpoint.
Mortality in this population was significantly reduced by 31% and by 36% up to 42 months.
In the monotherapy population, vutrisiran reduced the risk of all-cause mortality and recurrent cardiovascular events by 33% and reduced the risk of mortality by 35% up to 42 months.
A non-significant reduction of 30% in mortality was observed (nominal p-value 0.1179) in the monotherapy population.
Vutrisiran treatment was also associated with benefits versus placebo across multiple well-established clinical measures of disease progression.
At the ESC congress, Alnylam said that at month 30, patients on vutrisiran experienced a decline in 6-MWT of 26.46 meters from baseline, while 32.09 meters for the placebo arm.
Subgroup analyses of the primary and secondary endpoints demonstrated generally consistent results across all key patient segments, including patients receiving Pfizer Inc’s (NYSE:PFE) Vyndamax (tafamidis) at baseline.
In patients receiving baseline tafamidis, vutrisiran demonstrated a 22% reduction in the composite primary endpoint of ACM and recurrent CV events and a 41% reduction in ACM at 42 months versus placebo.
Trends toward greater than average benefit were seen in patients with baseline characteristics indicative of early disease.
The company remains on track to proceed with global regulatory submissions for vutrisiran starting later this year, including filing a supplemental New Drug Application with the FDA using a Priority Review Voucher.
BridgeBio Pharma Inc. (NASDAQ:BBIO) has ATTR-CM therapy acoramidis, currently under FDA priority review with an FDA action date of November 29. BridgeBio Pharma stock jumped in reaction.
Price Action: ALNY stock is down 5.9% at $270.00 at last check Friday.
Photo via Shutterstock
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