Is Alnylam Pharmaceuticals (ALNY) a Must-Hold Momentum Buy in 2026?

Alnylam Pharmaceuticals (NASDAQ:ALNY) has emerged as a pivotal player in the RNAi therapeutics space, with its recent financial and pipeline developments generating significant investor interest. As the company navigates a transformative phase in its growth trajectory, the question of whether ALNY merits a "must-hold" status in 2026 hinges on a nuanced evaluation of its commercial performance, pipeline momentum, and market sentiment.

Commercial Performance: A Story of Explosive Growth and Lingering Risks

Alnylam's Q3 2025 results underscored its ability to capitalize on blockbuster product launches. Total Net Product Revenues surged to $851 million, a 103% year-over-year increase, driven by $724 million in TTR Revenues-a 135% YoY jump-attributed to the successful rollout of AMVUTTRA (vutrisiran) and sustained demand for GIVLAARI and OXLUMO. This growth propelled the company to raise its 2025 revenue guidance to $2.95 billion–$3.05 billion, a $275 million upward revision. Earnings per share (EPS) of $2.90 in Q3 2025 far exceeded the Zacks Consensus Estimate of $1.67, signaling robust profitability.

However, the stock experienced a 6.7% decline following the release of these results, driven by an external inquiry into the company's commercial and pricing practices. While the inquiry's resolution remains pending, investors must weigh the short-term volatility against Alnylam's long-term value proposition.

Pipeline Momentum: Positioning for 2026 and Beyond

Alnylam's pipeline is a cornerstone of its momentum thesis, with multiple high-impact programs advancing toward pivotal milestones.

1. Next-Generation TTR Silencers:
2. Nucresiran, a subcutaneous TTR silencer, is in Phase 3 trials (TRITON-CM and TRITON-PN) for ATTR amyloidosis. The TRITON-PN trial, randomizing patients in a 4:1 ratio to nucresiran or vutrisiran, aims to demonstrate superiority over existing therapies. Topline data is expected in 2028, with regulatory approval potentially achievable by 2030 for the TRITON-CM trial.

3. Vutrisiran is already showing promise, with 36% reduced all-cause mortality in ATTR-CM patients from the HELIOS-B trial and a March 2025 PDUFA date for U.S. regulatory approval.

4. Cardiovascular Breakthroughs with Zilebesiran:
   The ZENITH Phase 3 trial for zilebesiran, targeting hypertension and cardiovascular risk, is a standout. With 11,000 patients enrolled across 35 countries, the trial aims to demonstrate zilebesiran's ability to reduce major adverse cardiovascular events (MACE) through biannual dosing. Early KARDIA-3 data showed -5.0 mmHg systolic blood pressure reduction at Month 3, with sustained benefits through Month 6. If successful, zilebesiran could redefine hypertension management and generate blockbuster revenue.

5. Neuroscience Expansion:
   Alnylam is also advancing mivelsiran for early-onset Alzheimer's and ALN-HTT02 (in partnership with Regeneron) for Huntington's disease. These programs, though earlier-stage, highlight the company's diversification into high-unmet-need therapeutic areas.

Analyst Sentiment: A Bullish Consensus with Caution

Analyst ratings reflect strong confidence in Alnylam's future. As of October 2025, 21 "Buy" ratings and 7 "Hold" ratings (out of 48) underscore a "Strong Buy" consensus. The average price target of $482.17 represents a 5.4% increase from prior estimates, with top targets like $583.00 (Citigroup) signaling optimism about 2026 outcomes.
However, the wide range of targets ($296–$580) suggests divergent views on the pipeline's commercialization risks. For instance, while zilebesiran's ZENITH trial could unlock significant value, its event-driven design and long-term safety profile remain unproven.

Risks and Mitigants

Despite the bullish momentum, three risks warrant attention:
1. Regulatory and Pricing Scrutiny: The ongoing inquiry into pricing practices could delay market access or necessitate price concessions.
2. Pipeline Execution Risks: Delays or failures in TRITON-CM, ZENITH, or nucresiran could dampen growth projections.
3. Competition: Emerging RNAi therapies from rivals like Ionis Pharmaceuticals or Roche could erode market share.

Alnylam's first-mover advantage in TTR amyloidosis and its proprietary GalNAc conjugate platform provide a durable moat, but investors must monitor these risks closely.

Conclusion: A Must-Hold for 2026?

Alnylam Pharmaceuticals' 103% revenue growth, pipeline of next-gen therapeutics, and bullish analyst consensus position it as a compelling momentum play for 2026. The ZENITH trial and nucresiran's potential could drive revenue to $5.32 billion by 2026, aligning with analyst forecasts. While the share price volatility and regulatory risks are non-trivial, the company's innovative platform and durable leadership in RNAi justify a "must-hold" designation for investors with a medium-to-long-term horizon.

In the words of one analyst, "Alnylam's ability to transform rare diseases into curable conditions is unmatched, and its 2026 milestones could redefine its valuation trajectory".