Alnylam Stock Soars on Strong Results in Heart Drug Study
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Key Takeaways
Alnylam Pharmaceuticals announced a Phase-3 study of its treatment for a rare heart condition showed a significant reduction in deaths and recurrent cardiovascular events.
The biopharmaceutical company said it would be seeking regulatory approval later this year, including asking the Food and Drug Administration for a priority review.
The news sent shares of Alnylam soaring over 31% in early trading Monday.
Shares of Alnylam Pharmaceuticals (
ALNY
) skyrocketed over 31% in early trading Monday after the biopharma firm announced strong results from a late-stage study of its RNA interference drug for a rare heart condition.
The company reported a Phase-3 trial of its vutrisiran showed “a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular (CV) events” in patients suffering from transthyretin amyloidosis with cardiomyopathy, or ATTR-CM. That’s a condition which causes the heart to stiffen and reduces its ability to pump blood. Alnylam added that vutrisiran also produced significant improvements across all secondary endpoints for those treated.
Seeking Regulatory Approval
Chief Medical Officer Dr. Pushkal Garg said the company is “moving with urgency to file these compelling data with regulators to bring this medicine to patients around the world.” Alnylam said it would be moving ahead with submissions to health officials starting later this year, including asking the
Food and Drug Administration (FDA)
for a Priority Review Voucher.
CEO Dr. Yvonne Greenstreet added that if it receives approval, “vutrisiran has the potential to become the new standard of care for the treatment of this disease, driving Alnylam’s next era of substantial growth.”
Vutrisiran, which goes under the brand name Amvuttra, has already been approved to treat nerve damage in those with hereditary transthyretin amyloidosis.
The news sent shares of Alnylam up over 31% to $219.09 as of 10:20 a.m. ET Monday. With Monday’s gains, the stock has climbed about 14% since the start of the year.
