Street Calls of the Week
Investing.com - H.C. Wainwright has reiterated its Buy rating and $570.00 price target on Alnylam Pharmaceuticals (NASDAQ:ALNY), representing a 25% upside from the current price of $456.95. The company, now valued at approximately $60 billion, has seen its stock surge over 100% in the past six months, according to InvestingPro data, citing potential benefits from recent FDA draft guidances.
The investment firm noted that Alnylam stands to gain from the FDA’s September 2025 draft guidances that broaden flexibility in clinical trial design and expand the role of real-world evidence across genetic medicines. While currently showing negative earnings, InvestingPro analysis indicates expected profitability this year, with analysts forecasting EPS of $3.63 for 2025.
While the FDA guidances primarily focus on cell and gene therapy, H.C. Wainwright believes their core themes have meaningful implications for RNA interference (RNAi) therapeutics, which form the foundation of Alnylam’s drug development platform.
The firm specifically highlighted three key aspects of the guidances that could benefit Alnylam: adaptive and externally controlled trial design, incorporation of real-world evidence and registries for confirmatory data, and early pediatric inclusion.
These regulatory developments could support Alnylam’s evolving pipeline strategy across cardiometabolic, hepatic, and rare disease indications, where real-world data and platform continuity are increasingly central to clinical development, according to H.C. Wainwright.
In other recent news, Alnylam Pharmaceuticals reported strong earnings results, with impressive sales data for its drug Amvuttra. RBC Capital raised its price target for Alnylam to $500 from $435, citing a significant increase in Amvuttra sales, which reached $167 million in August. Stifel also increased its price target to $495 from $441, highlighting the strong performance of Vutrisiran, another of Alnylam’s treatments. Meanwhile, Alnylam has ceased airing a television commercial for its heart medicine, Amvuttra, following a warning letter from the FDA regarding misleading content.
New analyses from Alnylam’s HELIOS-B Phase 3 study revealed that Vutrisiran significantly reduced gastrointestinal events in patients with transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM). The results showed a 37-49% reduction in gastrointestinal events compared to placebo. Alnylam has also joined the Alliance for Genomic Discovery, aiming to advance RNA interference therapies by utilizing a comprehensive clinical genomic database. These developments reflect Alnylam’s ongoing efforts to enhance its therapeutic offerings and expand its research capabilities.
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