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Can Alnylam's Pipeline Drugs Sustain Long-Term Growth Ahead?
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Key Takeaways
Alnylam reported $2.99B in 2025 net product revenues, up 81% YoY, driven by four approved drugs.
ALNY's cemdisiran hit key phase III endpoints in generalized MG, with partner Regeneron planning U.S. filing.
Zilebesiran and mivelsiran advance in late and mid-stage studies, targeting cardiovascular and AD markets.
Alnylam Pharmaceuticals (ALNY - Free Report) currently markets four approved drugs — Onpattro, Givlaari, Oxlumo and Amvuttra — that together generated $2.99 billion in net product revenues, representing a 81% year-over-year increase in 2025. The company also recognizes collaboration revenues from its partners like Regeneron (REGN - Free Report) , Roche, Novartis and Sanofi, which add to the top line. ALNY’s partnership with Novartis added a fifth approved product, Leqvio. Royalty revenues from its sales have been boosting top-line growth.
To sustain long-term growth, Alnylam has made significant investments to build a broad and promising pipeline capable of driving future revenues. The company is currently advancing several candidates, with key programs including cemdisiran, mivelsiran and zilebesiran.
In 2024, Alnylam granted Regeneron exclusive rights to develop cemdisiran as a monotherapy and in combination with anti-C5 antibodies for complement-mediated indications. Regeneron is evaluating cemdisiran in combination with pozelimab, in a phase III clinical study for paroxysmal nocturnal hemoglobinuria and as a monotherapy and in combination with pozelimab in phase III clinical studies for myasthenia gravis (MG) and geographic atrophy. In 2025, Regeneron reported that cemdisiran monotherapy achieved both the primary and key secondary endpoints in the phase III study for generalized MG and plans to submit a regulatory filing seeking its U.S. approval soon, pending FDA discussions. Subject to approval, Alnylam will earn royalties on the drug’s sales, per their agreement.
Alnylam’s phase II KARDIA program showed that zilebesiran, an RNAi therapy targeting angiotensinogen, was effective both as a standalone treatment and in combination with standard antihypertensive drugs, highlighting its potential as a best-in-class option for patients with high cardiovascular risk. Additional positive results from the KARDIA-3 study, conducted with Roche, demonstrated sustained reductions in systolic blood pressure, improved cardiovascular and renal biomarkers, and a favorable safety profile, with the 300 mg dose showing the strongest benefits.
Based on such results, the companies have initiated dosing in the global phase III ZENITH cardiovascular outcomes study in 2025, which is evaluating the potential of zilebesiran to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension.
Alnylam is developing its wholly-owned pipeline candidate, mivelsiran (formerly ALN-APP), for treating early-onset Alzheimer’s disease (AD) and cerebral amyloid angiopathy (CAA). The company expects to initiate a phase II study on mivelsiran for AD in the first half of 2026. Additionally, patient enrollment and dosing are currently ongoing in a separate phase II study of the candidate for CAA.
The continued progress of these and several other clinical-stage pipeline candidates, alongside Alnylam’s marketed therapies, has the potential to meaningfully expand and diversify its commercial portfolio.
ALNY’s Market Competition for Lead Drug Amvuttra
Alnylam’s primary top-line driver is its newest drug, Amvuttra, which is approved for polyneuropathy of hereditary transthyretin-mediated amyloidosis and ATTR amyloidosis with cardiomyopathy in adults. The drug generated $2.31 billion in global sales in 2025, representing a staggering 138% year-over-year growth, driven by patient demand.
Alnylam’s Amvuttra faces notable competition in the ATTR-CM market from Pfizer’s (PFE - Free Report) Vyndaqel/Vyndamax (tafamidis) and BridgeBio’s (BBIO - Free Report) Attruby (acoramidis), both of which are already approved for this indication. While Amvuttra is positioned with a differentiated clinical profile, Pfizer’s and BridgeBio’s therapies carry the advantage of oral administration and comparatively lower list prices in the United States.
Vyndaqel is one of the key products that has driven improvement in Pfizer’s revenues in 2025. Global Vyndaqel family revenues of $6.38 billion rose 17% year over year in 2025, driven by continued demand growth. Pfizer’s Vyndaqel family includes global revenues from Vyndaqel as well as revenues for Vyndamax in the United States and Vynmac in Japan.
BridgeBio received FDA approval for Attruby in 2024. The drug generated U.S. sales worth $362.4 million in 2025, driven by increasing patient adoption and prescriber utilization. BBIO reported that as of Feb. 20, 2026, 7,804 unique patient prescriptions for Attruby have been written in the United States by 1,856 unique healthcare providers since approval. BridgeBio is also currently evaluating acoramidis for the prevention of early-stage variant transthyretin amyloidosis in a late-stage study.
ALNY’s Stock Price, Valuation and Estimates
Shares of Alnylam have plunged 31.4% in the past six months against the industry’s 14.8% growth. The stock has also underperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
ALNY Stock Price Movement
Image Source: Zacks Investment Research
From a valuation standpoint, Alnylam stock is expensive. Going by the price/sales ratio, the company’s shares currently trade at 11.55 trailing 12-month sales per share, much higher than 2.39 for the industry. The stock, however, is trading below its five-year mean of 19.37.
ALNY Stock Valuation
Image Source: Zacks Investment Research
Estimates for Alnylam’s 2026 earnings have decreased from $10.44 to $9.57 per share in the past 60 days, and estimates for 2027 earnings have decreased from $18.15 to $15.03 over the same time frame.
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Can Alnylam's Pipeline Drugs Sustain Long-Term Growth Ahead?
Key Takeaways
Alnylam Pharmaceuticals (ALNY - Free Report) currently markets four approved drugs — Onpattro, Givlaari, Oxlumo and Amvuttra — that together generated $2.99 billion in net product revenues, representing a 81% year-over-year increase in 2025. The company also recognizes collaboration revenues from its partners like Regeneron (REGN - Free Report) , Roche, Novartis and Sanofi, which add to the top line. ALNY’s partnership with Novartis added a fifth approved product, Leqvio. Royalty revenues from its sales have been boosting top-line growth.
To sustain long-term growth, Alnylam has made significant investments to build a broad and promising pipeline capable of driving future revenues. The company is currently advancing several candidates, with key programs including cemdisiran, mivelsiran and zilebesiran.
In 2024, Alnylam granted Regeneron exclusive rights to develop cemdisiran as a monotherapy and in combination with anti-C5 antibodies for complement-mediated indications. Regeneron is evaluating cemdisiran in combination with pozelimab, in a phase III clinical study for paroxysmal nocturnal hemoglobinuria and as a monotherapy and in combination with pozelimab in phase III clinical studies for myasthenia gravis (MG) and geographic atrophy. In 2025, Regeneron reported that cemdisiran monotherapy achieved both the primary and key secondary endpoints in the phase III study for generalized MG and plans to submit a regulatory filing seeking its U.S. approval soon, pending FDA discussions. Subject to approval, Alnylam will earn royalties on the drug’s sales, per their agreement.
Alnylam’s phase II KARDIA program showed that zilebesiran, an RNAi therapy targeting angiotensinogen, was effective both as a standalone treatment and in combination with standard antihypertensive drugs, highlighting its potential as a best-in-class option for patients with high cardiovascular risk. Additional positive results from the KARDIA-3 study, conducted with Roche, demonstrated sustained reductions in systolic blood pressure, improved cardiovascular and renal biomarkers, and a favorable safety profile, with the 300 mg dose showing the strongest benefits.
Based on such results, the companies have initiated dosing in the global phase III ZENITH cardiovascular outcomes study in 2025, which is evaluating the potential of zilebesiran to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension.
Alnylam is developing its wholly-owned pipeline candidate, mivelsiran (formerly ALN-APP), for treating early-onset Alzheimer’s disease (AD) and cerebral amyloid angiopathy (CAA). The company expects to initiate a phase II study on mivelsiran for AD in the first half of 2026. Additionally, patient enrollment and dosing are currently ongoing in a separate phase II study of the candidate for CAA.
The continued progress of these and several other clinical-stage pipeline candidates, alongside Alnylam’s marketed therapies, has the potential to meaningfully expand and diversify its commercial portfolio.
ALNY’s Market Competition for Lead Drug Amvuttra
Alnylam’s primary top-line driver is its newest drug, Amvuttra, which is approved for polyneuropathy of hereditary transthyretin-mediated amyloidosis and ATTR amyloidosis with cardiomyopathy in adults. The drug generated $2.31 billion in global sales in 2025, representing a staggering 138% year-over-year growth, driven by patient demand.
Alnylam’s Amvuttra faces notable competition in the ATTR-CM market from Pfizer’s (PFE - Free Report) Vyndaqel/Vyndamax (tafamidis) and BridgeBio’s (BBIO - Free Report) Attruby (acoramidis), both of which are already approved for this indication. While Amvuttra is positioned with a differentiated clinical profile, Pfizer’s and BridgeBio’s therapies carry the advantage of oral administration and comparatively lower list prices in the United States.
Vyndaqel is one of the key products that has driven improvement in Pfizer’s revenues in 2025. Global Vyndaqel family revenues of $6.38 billion rose 17% year over year in 2025, driven by continued demand growth. Pfizer’s Vyndaqel family includes global revenues from Vyndaqel as well as revenues for Vyndamax in the United States and Vynmac in Japan.
BridgeBio received FDA approval for Attruby in 2024. The drug generated U.S. sales worth $362.4 million in 2025, driven by increasing patient adoption and prescriber utilization. BBIO reported that as of Feb. 20, 2026, 7,804 unique patient prescriptions for Attruby have been written in the United States by 1,856 unique healthcare providers since approval. BridgeBio is also currently evaluating acoramidis for the prevention of early-stage variant transthyretin amyloidosis in a late-stage study.
ALNY’s Stock Price, Valuation and Estimates
Shares of Alnylam have plunged 31.4% in the past six months against the industry’s 14.8% growth. The stock has also underperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
ALNY Stock Price Movement
From a valuation standpoint, Alnylam stock is expensive. Going by the price/sales ratio, the company’s shares currently trade at 11.55 trailing 12-month sales per share, much higher than 2.39 for the industry. The stock, however, is trading below its five-year mean of 19.37.
ALNY Stock Valuation
Estimates for Alnylam’s 2026 earnings have decreased from $10.44 to $9.57 per share in the past 60 days, and estimates for 2027 earnings have decreased from $18.15 to $15.03 over the same time frame.
ALNY Estimate Movement
Alnylam currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.