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ALNY / Alnylam: FDA Rejection Of Onpattro For ATTR-CM Is A Setback, But A Manageable One

Alnylam: FDA Rejection Of Onpattro For ATTR-CM Is A Setback, But A Manageable One
Despite a positive panel recommendation, the FDA rejected the Alnylam Pharmaceuticals, Inc. application to market Onpattro for ATTR-CM, citing a lack of meaningful evidence of clinical efficacy. Amvuttra has always been the bigger opportunity in ATTR-CM, and now investors await the pivotal HELIOS-B clinical data in early 2024. Despite a good track record of drug development, ATTR-CM has been a tough target for Alnylam, and past failures (revusiran and Onpattro) are likely to drive elevated skepticism for HELIOS-B. Read More
Posted: Oct 10 2023, 18:08
Author Name: Seeking Alpha
Views: 112181

ALNY News  

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Alnylam: FDA Rejection Of Onpattro For ATTR-CM Is A Setback, But A Manageable One

By Seeking Alpha
October 10, 2023

Alnylam: FDA Rejection Of Onpattro For ATTR-CM Is A Setback, But A Manageable One

Despite a positive panel recommendation, the FDA rejected the Alnylam Pharmaceuticals, Inc. application to market Onpattro for ATTR-CM, citing a lack more_horizontal

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Alnylam Stock Is Dropping on Surprising FDA Rejection

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Drugmaker Alnylam wanted to expand approval of its drug Onpattro, but the Food and Drug Administration rejected the application even after an outside more_horizontal

US FDA declines approval for expanded use of Alnylam's heart-disease drug

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By Market Watch
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Alnylam to scrap sNDA for patisiran after receiving FDA complete response letter

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