Alnylam received a subpoena from the U.S. Attorney's Office for the District of Massachusetts concerning fee and discount arrangements with distributors for its four drugs, including AMVUTTRA, ONPATTRO, OXLUMO, and GIVLAARI. The investigation is part of a broader review of the company’s pricing and reimbursement practices.
Alnylam reported Q3 2025 revenue of $1.25 billion, a 149% increase compared with Q3 2024. GAAP net income rose to $251 million from a net loss of $112 million in the prior year’s quarter. Non‑GAAP earnings per share were $2.90, far above analyst expectations of $0.52. The TTR franchise generated $724 million in revenue, up 135% year‑over‑year, with AMVUTTRA sales reaching $685 million, a 165% increase.
Alnylam raised its full‑year 2025 guidance for TTR franchise net revenues to $2.475 billion–$2.525 billion and for total net product revenues to $2.95 billion–$3.05 billion.
The company launched two new Phase 3 trials: ZENITH for zilebesiran in hypertension and TRITON‑PN for nucresiran in hereditary ATTR‑polyneuropathy.
Alnylam has faced prior regulatory scrutiny, including an investigation in October 2023 for potential securities law violations related to an FDA Complete Response Letter for patisiran, and a settlement with the Office of Inspector General in May 2024 for $170,000 over alleged failure to submit pricing data to CMS in 2020, 2021, and 2023.
Management has not yet issued a statement on the subpoena; investors should monitor the company’s disclosures for updates on the investigation and any potential impact on its operations or financial results.
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