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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: 090891

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

By Barrons
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Alnylam Stock Is Dropping on Surprising FDA Rejection

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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