Alnylam Pharmaceuticals Prepares for Q4 Results with Amvuttra Sales Surge and Pipeline Advances
Key Insights
Alnylam Pharmaceuticals (search) is expected to report strong Q4 2025 results around February 12, 2026, with Amvuttra sales driving growth after a 162% year-over-year increase in Q3.
The company projects combined sales of Amvuttra and Onpattro to reach $2.5 billion for 2025, with most growth attributed to Amvuttra's success in treating transthyretin cardiac amyloidosis (search).
Management will likely announce the initiation of two key clinical studies: a Phase 3 trial for nucresiran in hereditary ATTR with polyneuropathy (search) and a Phase 2 trial for mivelsiran in Alzheimer's disease (search).
Alnylam Pharmaceuticals (search) is poised to deliver strong fourth-quarter 2025 results, driven by the continued commercial success of its blockbuster drug Amvuttra and advancing pipeline developments. Wall Street analysts expect the company to report total Q4 revenue of $1.16 billion and adjusted earnings per share of $1.50 when results are announced around February 12, 2026.
Amvuttra Drives Revenue Growth
The RNA interference therapeutics company's flagship drug Amvuttra has demonstrated exceptional commercial traction, with sales skyrocketing 162% year over year in the third quarter of 2025. This growth has been driven by rapid uptake in the transthyretin cardiac amyloidosis (search) (ATTR-CM) indication, establishing the drug as a key revenue driver for the company.
Alnylam's full-year 2025 guidance projects combined sales of Amvuttra and Onpattro to reach $2.5 billion at the midpoint of the range. Given that Onpattro's sales are declining, analysts expect all of the growth in Q4 to come from Amvuttra's continued expansion.
However, international market contributions are expected to remain limited in the near term. Chief Commercial Officer Tolga Tanguler noted during the Q3 earnings call that "the contribution of ex-U.S. market is going to remain relatively modest, especially for [the] fourth quarter." She indicated that stronger growth will likely be seen in Germany and Japan later in 2026.
Pipeline Developments and Clinical Milestones
Beyond commercial performance, Alnylam's management is expected to provide significant pipeline updates during the Q4 earnings call. Based on comments from the company's third-quarter earnings call, two major clinical study initiations are anticipated.
The company will likely report the initiation of a Phase 3 study evaluating nucresiran for the treatment of hereditary ATTR with polyneuropathy (search) (hATTR-PN). Additionally, Alnylam is expected to announce the start of a Phase 2 trial for mivelsiran in Alzheimer's disease (search), expanding the company's therapeutic reach into neurodegenerative disorders.
Financial Considerations and Market Position
While Amvuttra's success continues to drive growth, it comes with certain financial implications. As sales for the blockbuster drug increase, so do the royalty rates paid to Alnylam's partners, which is expected to result in declining gross margins for the company.
Despite these considerations, Alnylam maintains a robust pipeline featuring several promising candidates, including three programs currently in late-stage testing. The company also expects to file to advance three to four new therapies into clinical testing this year, demonstrating continued innovation in the RNA interference space.
The biotech company's stock momentum, which was strong in the first three quarters of 2025, has recently stalled, leaving investors looking for positive catalysts. The upcoming Q4 results and pipeline updates may provide the momentum investors are seeking, though analysts suggest there is no immediate urgency for investors to position themselves before the earnings announcement.