The U.S. Food and Drug Administration on Thursday approved Alnylam Pharmaceuticals Inc.'s (NASDAQ:ALNY) supplemental application for Amvuttra (vutrisiran).
The drug treats adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis, or ATTR-CM, to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits.
ATTR-CM is a rare heart condition where a protein called transthyretin (TTR) misfolds and deposits in the heart, causing it to stiffen and potentially leading to heart failure.
The approval expands the indication for Amvuttra, which now becomes the first and only therapeutic approved by the FDA for ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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JPMorgan upgraded Alnylam on Monday, citing a convincing multi-billion dollar opportunity for Amvuttra in TTR amyloidosis.
Following the survey, the analyst models a larger ATTR-CM market and higher overall sales for Amvuttra over time.
Analyst Jessica Fye models Amvuttra sales in cardiomyopathy (CM) of around $81 million in 2025 (vs. around $79 million prior), weighted towards 2H.
JP Morgan has upgraded to an Overweight rating from Neutral, raising the price target from $280 to $328.
"We see a majority of this opportunity from the large and growing ATTR-CM market where we expect strong uptake for Amvuttra in newly diagnosed patients but also from patients progressing on prior lines of therapy. This, in addition to ALNY's broad and attractive platform and intriguing pipeline supports what we see as a strong outlook for the business and our Overweight rating," JP Morgan writes.
Price Action: ALNY stock is up 3.50% at $293.25 at the last check Monday.
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