The U.S. Meals and Drug Administration on Thursday accepted Alnylam Prescription drugs Inc.’s ALNY supplemental utility for Amvuttra (vutrisiran).
The drug treats adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis, or ATTR-CM, to scale back cardiovascular mortality, cardiovascular hospitalizations, and pressing coronary heart failure visits.
ATTR-CM is a uncommon coronary heart situation the place a protein known as transthyretin (TTR) misfolds and deposits within the coronary heart, inflicting it to stiffen and doubtlessly resulting in coronary heart failure.
The approval expands the indication for Amvuttra, which now turns into the primary and solely therapeutic accepted 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 greenback alternative for Amvuttra in TTR amyloidosis.
Following the survey, the analyst fashions a bigger ATTR-CM market and better general gross sales for Amvuttra over time.
Analyst Jessica Fye fashions Amvuttra gross sales in cardiomyopathy (CM) of round $81 million in 2025 (vs. round $79 million prior), weighted in direction of 2H.
JP Morgan has upgraded to an Obese score from Impartial, elevating the value goal from $280 to $328.
“We see a majority of this chance from the big and rising ATTR-CM market the place we count on robust uptake for Amvuttra in newly identified sufferers but additionally from sufferers progressing on prior strains of remedy. This, along with ALNY’s broad and engaging platform and intriguing pipeline helps what we see as a powerful outlook for the enterprise and our Obese score,” JP Morgan writes.
Value Motion: ALNY inventory is up 3.50% at $293.25 on the final examine Monday.
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