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Investing.com -- Alnylam Pharmaceuticals (NASDAQ: NASDAQ:ALNY) stock climbed 5% as trading resumed on Friday morning, following the company’s announcement that the FDA has approved AMVUTTRA for treating ATTR Amyloidosis.
The FDA’s approval of AMVUTTRA marks a significant advancement in the treatment of transthyretin-mediated amyloidosis (ATTR), a condition that affects the heart and nerves. The drug is now the first and only FDA-approved therapy for both the cardiomyopathy and polyneuropathy manifestations of ATTR Amyloidosis in adults. This news comes after the positive results from the HELIOS-B Phase 3 clinical trial, which demonstrated that AMVUTTRA significantly reduced the risk of all-cause mortality and recurrent cardiovascular events.
Alnylam’s CEO, Yvonne Greenstreet, expressed gratitude to all involved in achieving this milestone and emphasized the company’s commitment to continuing innovation for patients with ATTR amyloidosis. The treatment, which is administered quarterly via subcutaneous injection, reduces the production of transthyretin (TTR), addressing the disease at its source.
The approval is particularly noteworthy given the disease’s impact on quality of life and its potential for causing premature death due to irreversible damage from TTR fibril deposition. The HELIOS-B trial’s findings have been well received, with the trial achieving statistical significance on all primary and secondary endpoints. Notably, AMVUTTRA reduced the risk of all-cause mortality by 28% and recurrent cardiovascular events by 28% during the double-blind treatment period of up to 36 months.
Analysts have responded positively to the news, with Canaccord Genuity analyst Whitney Ijem raising Alnylam’s price target to $390 from $385 and maintaining a Buy rating. Ijem highlighted the unchanged wholesale acquisition cost of AMVUTTRA, which is approximately $477,000 per year, and the company’s plans to offer volume-based rebates. Scotiabank (TSX:BNS) analyst Greg Harrison also raised the price target to $338 from $300, maintaining a Sector Outperform rating. Harrison noted the favorable label that includes a mortality benefit and reduction in cardiovascular hospitalizations and urgent heart failure visits.
Alnylam has also emphasized its commitment to patient access, with the majority of patients expected to pay $0 in out-of-pocket costs for AMVUTTRA, and multiple support programs in place to assist with treatment navigation. The company is preparing for additional global regulatory submissions for vutrisiran in 2025.
Investors are likely to keep a close eye on Alnylam’s next steps as the company seeks to expand the reach of AMVUTTRA globally and build on the positive momentum from the FDA approval.
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