ALNY
T3Alnylam Pharmaceuticals, Inc.
OverviewAlnylam Pharmaceuticals develops RNAi therapeutics, medicines that silence faulty genes to treat diseases. Their key products, like Amvuttra, address rare genet
Alnylam Pharmaceuticals develops RNAi therapeutics, medicines that silence faulty genes to treat diseases. Their key products, like Amvuttra, address rare genetic and cardio-metabolic conditions such as ATTR amyloidosis affecting the heart and nerves. The TTR franchise is the primary revenue driver, with an annual run rate exceeding $4 billion, complemented by rare disease, collaboration, and royalty revenues. They serve patients through healthcare providers and partner with other pharma companies.
Search Keywords Brand Product
- AMVUTTRA
- ONPATTRO
- GIVLAARI
- OXLUMO
- nucresiran
- zilebesiran
- ALN-6400
- ALN-HTT02
- ALN-2232
- mivelsiran
- LEQVIO
- RNAi therapeutics
- ATTR cardiomyopathy
- hereditary ATTR polyneuropathy
- acute hepatic porphyria
- primary hyperoxaluria type 1
- von Willebrand disease
- Huntington's disease
- Down syndrome Alzheimer's disease
- obesity weight management
- TTR amyloidosis
Search Keywords Event Phrases
- Q2 earnings 2026
- TRITON-CM trial
- ZENITH trial
- EHDN October
Search Keywords Policy Regulatory
- marketing authorization China Macau
- What They Do (Plain English & Analogies)
- Alnylam Pharmaceuticals is a biotechnology company that makes new medicines by using a natural process called RNA interference (RNAi). Imagine our genes are like instruction manuals for our bodies. Sometimes, a gene has a faulty instruction that causes a disease. Alnylam's RNAi medicines act like a 'mute button' or a 'dimmer switch' for these faulty genes. Instead of trying to fix the gene itself or block the protein it makes, their medicines stop the bad instruction from being read in the first place, effectively silencing the gene responsible for the illness. This allows them to treat diseases that were previously very difficult or impossible to address, such as certain rare genetic conditions and heart diseases.
- Very Brief History
- Founded in 2002, Alnylam Pharmaceuticals pioneered the development of RNA interference (RNAi) therapeutics. Over two decades, the company has evolved from a research-focused entity to a commercial leader, bringing six Alnylam-invented medicines to market. A significant milestone was achieved in 2025 with the landmark approval of Amvuttra for ATTR cardiomyopathy, which propelled the company to nearly $3 billion in annual revenues and, importantly, achieved GAAP profitability for the full year. The company continues to advance a broad pipeline of investigational medicines, including initiating Phase II trials for ALN-6400 in von Willebrand disease and mivelsiran in Down syndrome associated Alzheimer's disease in Q2 2026.
- "Street Stereotype"
- Alnylam is generally perceived as the leading innovator and commercial powerhouse in the RNAi therapeutics space. Investors and analysts view it as a high-growth biotech company with a robust, high-yielding pipeline and a proven platform that can consistently deliver new, transformative medicines, driving durable long-term growth and increasing profitability.
- Subsidiaries On Linked In*
- {"subsidiaries":[]}
- Customer Sectors & Example Clients
- Alnylam's primary customers are patients suffering from various diseases, with treatments administered through healthcare providers and hospital systems. Their therapeutic focus areas include genetic medicines, cardio-metabolic diseases, hepatic infectious diseases, central nervous system (CNS)/ocular diseases, rare diseases, hypertension, metabolic diseases (overweight/obesity, type 2 diabetes), neuroscience (Alzheimer's disease, Huntington's disease, cerebral amyloid angiopathy), and hematology (bleeding disorders). The company also engages in strategic collaborations with other pharmaceutical companies, which can be considered 'clients' or partners in development and commercialization. Example collaborators include Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Novartis AG, Roche, and BeOne.
- New Customers / Segments They'Re Targeting
- Alnylam is actively targeting new customer segments by broadening its AMVUTTRA prescriber base, particularly expanding beyond academic centers to community expert centers. They are also investing in diagnosis-enabling initiatives to identify patients earlier and expand the treatable population for ATTR cardiomyopathy. Geographically, they are expanding their presence, notably through a collaboration with BeOne for exclusive commercialization and distribution rights for AMVUTTRA in Mainland China and Macau, subject to marketing authorization. Furthermore, their pipeline targets new disease areas such as von Willebrand disease (ALN-6400), Down syndrome associated Alzheimer's disease (mivelsiran), Huntington's disease (ALN-HTT02), and obesity and weight management (ALN-2232).
- Supply Chain And Sourcing Geographies
- Alnylam manages the manufacturing and distribution of all its commercial and investigational medicines worldwide from its large-scale manufacturing facilities located in Cambridge, Massachusetts, and Norton, Massachusetts, USA. The company has also developed and launched a proprietary enzymatic ligation-based RNAi manufacturing platform called Cyrillis (also referred to as siRELIS™), which is expected to greatly expand capacity, reduce costs, and support future launches. This platform has been accepted into the U.S. FDA's Emerging Technology Program.
- Sales Geographies And Expansion Plans
- Alnylam currently sells its products globally, with a strong commercial foothold in the United States and Europe. Specific sales geographies mentioned include the U.S., Japan, the U.K., and Germany, where ATTR-CM uptake continues. Their European business offices are located in Maidenhead, UK, and Zug, Switzerland, with satellite offices in Munich, Germany; Amsterdam, Netherlands; Vienna, Austria; Paris, France; Milan, Italy; Madrid, Spain; and Stockholm, Sweden. Other global offices include Tokyo, Japan; Sao Paulo, Brazil; and Mississauga, Ontario, Canada. The company is actively expanding its geographic reach, notably through a collaboration with BeOne for exclusive commercialization and distribution rights for AMVUTTRA in Mainland China and Macau, subject to marketing authorization.
- How Key Themes May Help/Hurt
- The 'GLP-1 Long '26: RNA Fat Redistribution' theme is highly beneficial for Alnylam. The company is developing ALN-2232 for obesity and weight management, which directly aligns with the theme's focus on improved body composition and visceral fat reduction. As the market shifts towards more sophisticated obesity treatments that go beyond mere weight loss to address fat redistribution and muscle preservation, Alnylam's RNAi approach could offer a differentiated mechanism of action. The long-term bullish sentiment around GLP-1s and related metabolic treatments creates a favorable environment for new, innovative therapies in this space, potentially accelerating ALN-2232's development and market adoption, thereby contributing to Alnylam's long-term growth and diversification beyond its TTR franchise.
3 Main Long-Term Bull Details
- Global Leadership in RNAi Therapeutics and Expanding TTR Franchise: Alnylam is the established leader in RNAi therapeutics with a proven platform. The AMVUTTRA launch in ATTR cardiomyopathy has been exceptionally strong, exceeding $1 billion in quarterly revenue for the first time in Q2 2026, and is on track to achieve TTR leadership by 2030. The anticipated delay in tafamidis generic entry until mid-2031 and the negative outcome of a competitor's study (eplontersen) further strengthen AMVUTTRA's competitive position and the overall TTR franchise.
- Robust and High-Yielding Pipeline with Blockbuster Potential: Beyond TTR, Alnylam boasts a deep and diverse pipeline of over 25 clinical programs, with a goal to reach over 40 by 2030. Key late-stage programs like nucresiran (for ATTR amyloidosis) and zilebesiran (for hypertension) are advancing in pivotal Phase III trials, with nucresiran expected to launch in 2028 (hATTR-PN) and 2030 (ATTR-CM). Promising early-stage assets in obesity (ALN-2232), Huntington's disease (ALN-HTT02), and bleeding disorders (ALN-6400) offer significant long-term growth potential and diversification.
- Strong Financial Trajectory and Sustained Profitability: Alnylam achieved GAAP profitability in 2025 and expects to sustain it. The company targets over 25% revenue CAGR through 2030 and a non-GAAP operating margin of 30% across the period, with potential to reach mid-40s post-2030 if nucresiran is successful due to the lack of royalty obligations. The strong operating performance in Q2 2026, with non-GAAP operating income more than tripling year-over-year, demonstrates effective financial discipline and growth.
3 Main Long-Term Bear Details
- Competitive Landscape and Market Share Dynamics: While the competitive landscape has recently become more favorable with the eplontersen study failure and tafamidis generic delay, intense competition remains. The long-term impact of tafamidis generic entry in Europe and eventually the U.S. (2031) could still exert pricing pressure and affect market share. New entrants or gene-editing technologies in the future could also pose disruptive threats to Alnylam's chronic dosing model.
- Pipeline Execution and Clinical Risk: A significant portion of Alnylam's ambitious 'Alnylam 2030' growth targets relies on the successful development and commercialization of pipeline assets. Delays in pivotal Phase III trials (TRITON-CM/PN for nucresiran, ZENITH for zilebesiran), unexpected safety signals, or challenges in market access and uptake for these future products could significantly impact the company's ability to achieve its long-term financial and strategic goals. The company's confidence in TRITON-CM for nucresiran, despite the eplontersen failure, still carries inherent clinical trial risk.
- Revenue Guidance Adjustments and Demand Normalization: Alnylam lowered its 2026 total net product revenue guidance, specifically for TTR revenue, by $200 million at the midpoint. This was attributed to a better understanding of the normalization of second-line demand for AMVUTTRA after an initial surge from pent-up demand. While first-line growth remains strong, this adjustment highlights the challenges in accurately forecasting demand dynamics in a rapidly evolving market and could temper investor confidence in future projections.
- Competitors And Differentiation
- Alnylam faces competition from established players like Pfizer (tafamidis) and emerging therapies from companies like Ionis Pharmaceuticals (eplontersen/WAINUA). Their primary differentiation lies in their pioneering RNAi technology, which offers rapid, deep, and durable TTR knockdown. For AMVUTTRA, they highlight its compelling clinical profile from the HELIOS-B study, demonstrating robust treatment effects on all-cause mortality and cardiovascular events, functional capacity, and quality of life, even with background stabilizers. It is the first and only product approved in the U.S. for both ATTR-CM and hereditary ATTR-PN, offering the convenience of once-quarterly administration and high adherence. For their next-generation therapy, nucresiran, Alnylam emphasizes its potential for even greater TTR knockdown (over 95% with two doses per year) and believes the negative outcome of the CARDIO-TTRansform study for eplontersen reinforces the distinct advantages of RNAi therapeutics over antisense oligonucleotides (ASOs) and their own meticulous study design and execution. They also compete with Novartis, whose LEQVIO sales contribute to Alnylam's royalty revenue.
- Recent Performance & What The Market'S Focused On
- Alnylam demonstrated strong performance in Q2 2026, with total global net product revenues of approximately $1.2 billion, representing 74% growth versus Q2 last year. This marked the first time AMVUTTRA revenues exceeded $1 billion in a single quarter, reaching an annual run rate of over $4 billion. Non-GAAP operating income more than tripled year-over-year to $318 million. However, the company revised its full-year 2026 total net product revenue guidance downwards to $4.7 billion to $5.1 billion, primarily due to a $200 million reduction in TTR revenue guidance. This revision reflects a better understanding of the normalization of second-line demand for AMVUTTRA, which benefited from pent-up demand in early 2025. The market is currently focused on Alnylam's ability to sustain AMVUTTRA's growth trajectory, particularly in the first-line setting (which now accounts for about 80% of new treatment initiations), and its confidence in the TRITON-CM study for nucresiran following a competitor's negative outcome. Investors are also tracking upcoming pipeline milestones, including four key data readouts in the second half of 2026 for ALN-6400, ALN-HTT02, and ALN-2232.
- Revenue Segments And Estimated Mix
- Total Global Net Product Revenues — Mix: n/m; Source: Q2 2026 actual: ~$1.2 billion; Revised 2026 guidance: $4.7 billion to $5.1 billion; Trend: 74% growth in Q2 2026 vs Q2 2025; Revised 2026 guidance reflects robust 75% growth year-over-year at midpoint
- TTR Revenue (AMVUTTRA, ONPATTRO) — Mix: ~89.4% of revised 2026 product sales guidance midpoint; Source: Q2 2026 actual: $1.03 billion; Revised 2026 guidance: $4.2 billion to $4.5 billion; Trend: 89% growth in Q2 2026 vs Q2 2025; 13% growth vs Q1 2026; Represents a $200 million reduction from original TTR guidance at midpoint
- Rare Disease Net Revenue (GIVLAARI, OXLUMO) — Mix: ~10.6% of revised 2026 product sales guidance midpoint; Source: Q2 2026 actual: $142 million; Trend: 11% growth in Q2 2026 vs Q2 2025
- Collaboration Revenue — Mix: n/m; Source: Q2 2026 actual: $47 million; Revised 2026 guidance: $575 million to $625 million; Trend: 23% decrease in Q2 2026 vs Q2 2025; Revised 2026 guidance represents a $150 million increase at midpoint, driven by higher cost reimbursement from Roche
- Royalty Revenue — Mix: n/m; Source: Q2 2026 actual: $72 million; Revised 2026 guidance: included in Collaboration and Royalty range of $575 million to $625 million; Trend: 79% increase in Q2 2026 vs Q2 2025, driven by higher LEQVIO sales by Novartis
- Product Brands
- ONPATTRO
- GIVLAARI
- OXLUMO
- AMVUTTRA
- zilebesiran
- nucresiran
- ALN-2232
- ALN-5288
- ALN-4285
- ALN-4915
- cemdisiran
- valesiran
- ALN-HTT02
- ALN-6400
- ALN-4324
- Cyrillis
- mivelsiran
Bull / Bear DetailsAlnylam, an RNAi therapeutics leader, is poised for sustained growth driven by its TTR franchise, particularly AMVUTTRA's strong first-line ATTR cardiomyopathy
Thesis
Alnylam, an RNAi therapeutics leader, is poised for sustained growth driven by its TTR franchise, particularly AMVUTTRA's strong first-line ATTR cardiomyopathy uptake. Despite a lowered 2026 revenue guidance due to second-line demand normalization, the competitive landscape has improved, reinforcing confidence in its 25% revenue CAGR target through 2030. A robust pipeline and strategic AI initiatives underpin a compelling bull case as of 2026-08-28.
Bull case
AMVUTTRA's exceptional commercial performance, exceeding $1 billion in quarterly revenue and an annual run rate over $4 billion, demonstrates strong market penetration. Its leadership in first-line ATTR cardiomyopathy new patient starts (80% of category growth) and expanding prescriber base, coupled with a more favorable competitive landscape after the eplontersen study failure, underpins durable TTR franchise growth.
Alnylam's deep and expanding pipeline, including nucresiran with potential best-in-class TTR knockdown, offers significant future growth. Key data readouts in H2 2026 for ALN-6400 (von Willebrand disease, HHT), ALN-HTT02 (Huntington's disease), and ALN-2232 (obesity) provide multiple catalysts. The continued advancement of these programs and strategic AI collaborations enhance long-term innovation and value creation.
The company's strong financial trajectory includes achieving GAAP profitability in 2025 and tripling non-GAAP operating income in Q2 2026. Despite revised 2026 guidance, management maintains confidence in its 25% revenue CAGR through 2030 and significant cash reserves ($3.3 billion). The anticipated launch of nucresiran without royalty obligations further supports future margin expansion.
Bear case
Alnylam lowered its 2026 total net product revenue guidance to $4.7 billion-$5.1 billion, and TTR revenue guidance to $4.2 billion-$4.5 billion. This revision reflects a better understanding of normalized second-line demand for AMVUTTRA, which benefited from pent-up demand in 2025. Ongoing modest quarter-to-quarter net price decreases for AMVUTTRA are also expected.
Despite confidence in nucresiran, pipeline execution and clinical risk remain. While the CARDIO-TTRansform study failure for eplontersen reduces competition, nucresiran's TRITON-CM trial still faces inherent risks. Delays, unexpected safety signals, or challenges in demonstrating superior efficacy could impact its projected 2030 launch for ATTR cardiomyopathy and long-term growth targets.
Pricing pressure and market access challenges persist, particularly in international markets where generic tafamidis is emerging in Europe. While AMVUTTRA's label and evidence are unaffected by competitor failures, payers may still scrutinize combination use. Managing gross-to-net deductions and securing broad, favorable access for new launches will be crucial for maintaining profitability and market share.
Bull / Bear Case
- Bear Case
- Alnylam lowered its 2026 total net product revenue guidance to $4.7 billion-$5.1 billion, and TTR revenue guidance to $4.2 billion-$4.5 billion, reflecting a $200 million reduction at the midpoint due to normalized second-line demand for AMVUTTRA. This revision, coupled with ongoing modest net price decreases for AMVUTTRA, highlights execution risk and market sensitivity. Despite confidence in nucresiran, pipeline execution and clinical risk remain, as delays or unexpected safety signals in the TRITON-CM trial could impact its projected 2030 launch. Pricing pressure and market access challenges persist, particularly in international markets with emerging generic tafamidis. The stock has underperformed, falling over 28% post-Q2 earnings and 40.28% year-to-date, indicating investor concern over growth projections and valuation.
- Bull Case
- Alnylam Pharmaceuticals is poised for sustained growth, driven by AMVUTTRA's exceptional commercial performance, exceeding $1 billion in quarterly revenue and an annual run rate over $4 billion. Its leadership in first-line ATTR cardiomyopathy new patient starts (80% of category growth) and expanding prescriber base, coupled with a more favorable competitive landscape after the eplontersen study failure and delayed tafamidis generic entry to 2031, underpins durable TTR franchise growth. The company boasts a deep pipeline, including nucresiran with potential best-in-class TTR knockdown and multiple catalysts in H2 2026. Alnylam achieved GAAP profitability in 2025, tripled non-GAAP operating income in Q2 2026, and maintains confidence in its 25% revenue CAGR target through 2030, supported by $3.3 billion in cash and strategic AI collaborations.
- More Compelling & Why
- Bear. Despite some intrinsic value models suggesting undervaluation, the current P/E ratio of 40.8x is significantly higher than the biotech industry average of 17.4x, indicating the stock is still richly priced for future growth. The strongest bear argument is the recent 28% stock drop following the lowered 2026 revenue guidance due to normalized second-line demand, signaling execution risk and market sensitivity to growth expectations. My view would flip if the company consistently meets or exceeds its revised guidance and demonstrates a clear, sustained acceleration in first-line AMVUTTRA uptake, leading to a more favorable P/E relative to its growth trajectory.
Key Factors
| Key Factor | Why It Matters | What To Watch | What It Signals | Where/How To Track | Free Alt Data | Paid Alt Data |
|---|---|---|---|---|---|---|
| 2026 TTR Net Product Revenue Performance relative to revised guidance | This revised guidance reflects a better understanding of AMVUTTRA's demand dynamics, particularly the normalization of second-line patient starts, and directly impacts investor expectations for the company's near-term financial performance and overall growth trajectory. | Actual reported TTR net product revenues for Q3 and Q4 2026. The revised full-year 2026 TTR revenue guidance is $4.2 billion to $4.5 billion. | Bullish: If actual Q3/Q4 TTR revenues allow the company to meet or exceed the upper end of the revised $4.2B-$4.5B guidance. Bearish: If actual Q3/Q4 TTR revenues indicate a miss on the lower end of the revised guidance. | Alnylam's Q3 2026 earnings call (expected October 29, 2026) and Q4 2026 earnings call (expected February 2027), and corresponding financial reports (10-Q, 10-K). | Company press releases, investor relations website. | IQVIA National Prescription Audit (NPA) / Xponent: Overall prescription volume for AMVUTTRA. |
| Nucresiran TRITON-CM Phase 3 Progress & Competitive Landscape Updates | Nucresiran is a key future growth driver for the TTR franchise. Its success, especially in light of eplontersen's CARDIO-TTRansform failure, is crucial for Alnylam's long-term TTR leadership and margin expansion. Updates from scientific conferences can provide critical insights into competitive positioning and Alnylam's strategy. | Any announcements regarding TRITON-CM study adaptations (e.g., enrollment modifications, analytic plan changes) following the review of eplontersen data. Presentations at ESC Congress 2026 (August 28-31, 2026) for new clinical and real-world data on AMVUTTRA and zilebesiran, and any further insights on the TTR silencing landscape. | Bullish: Confirmation of continued strong enrollment, positive updates on study adaptations that enhance success probability, or data presented at ESC that reinforces AMVUTTRA's differentiation or nucresiran's potential. Bearish: Significant delays in TRITON-CM, unexpected safety signals, or competitive data that challenges Alnylam's TTR leadership. | Alnylam's press releases, investor relations website, R&D days, ClinicalTrials.gov updates, and scientific conference proceedings (e.g., ESC Congress 2026 presentations, EHDN in October). | ClinicalTrials.gov: Updates on TRITON-CM enrollment status and study design changes. Conference abstracts and presentations from ESC Congress. | GlobalData: Clinical trial intelligence for ATTR-CM pipeline. |
| Non-GAAP Operating Margin Trend | This metric reflects Alnylam's financial discipline and ability to translate strong top-line growth into sustainable profitability, a key component of its 'Alnylam 2030' goals and investor confidence. | Reported non-GAAP operating income and margin in Q3 2026 (expected October 29, 2026) and Q4 2026 earnings. The company targets a non-GAAP operating margin of 30% across the 2030 period. | Bullish: Non-GAAP operating margin shows improvement or exceeds expectations, indicating efficient management of R&D and SG&A expenses relative to revenue growth. Bearish: Non-GAAP operating margin declines or misses targets, suggesting disproportionate growth in operating expenses. | Alnylam's Q3 and Q4 2026 earnings calls and financial reports (10-Q, 10-K). | Company investor relations website for historical financial statements. | FactSet/Bloomberg Terminal: Consensus estimates for operating margin. |
| Key Pipeline Data Readouts in H2 2026 (ALN-6400, ALN-HTT02, ALN-2232) | These programs represent the next wave of innovation beyond the TTR franchise and are critical for Alnylam's 'Alnylam 2030' goals of delivering multiple blockbuster medicines and expanding into new therapeutic areas. | ALN-6400: Healthy volunteer Phase I data and initial Phase II results in hereditary hemorrhagic telangiectasia (HHT) in H2 2026. ALN-HTT02: Initial Phase I results in Huntington's disease at EHDN in October 2026. ALN-2232: Initial Phase I data in obesity and weight management in H2 2026. Look for positive safety, target engagement (e.g., >50% huntingtin knockdown for ALN-HTT02), and proof-of-concept efficacy. | Bullish: Positive safety and efficacy data (e.g., strong knockdown, clear proof-of-concept) leading to rapid progression to next clinical phases. Bearish: Negative safety signals, insufficient efficacy/knockdown, or delays in data readout. | Alnylam's Q3 and Q4 2026 earnings calls, scientific conference presentations (e.g., EHDN in October 2026), and press releases. | ClinicalTrials.gov: Updates on study status and results summaries. | BioPharma Dive: News and analysis on clinical trial results. |
| AMVUTTRA U.S. ATTR Cardiomyopathy First-Line New Patient Starts & Prescriber Expansion | First-line adoption is critical for long-term, durable growth and establishing AMVUTTRA as a foundational therapy, especially as second-line demand normalizes and the competitive landscape evolves. Expanding the prescriber base is key to capturing the large untreated patient population. | Percentage of new treatment initiations that are first-line starts (currently ~80% of category growth). Updates on the number of new AMVUTTRA prescribers. | Bullish: If first-line new patient starts continue to represent ~80% or more of category growth, or if the prescriber base expands significantly beyond the 1,700 new prescribers reported since launch. Bearish: If the proportion of first-line new patient starts declines, or if prescriber growth stagnates. | Alnylam's future earnings calls and investor presentations, where commercial updates are provided (e.g., Q3 2026 earnings call expected October 29, 2026). | Industry news and analyst reports covering ATTR-CM market trends. | IQVIA National Prescription Audit (NPA) / Xponent: New-to-brand prescriptions (NBRx) for AMVUTTRA vs. competitors in ATTR-CM, prescriber data. |
Key Reported Metrics, Reratings Triggers & ResultsThis metric demonstrates Alnylam's operational efficiency and profitability from its core business. Investors will scrutinize its growth to assess the company's
Upcoming print · 2026-10-29
| Key reported metrics | ||
|---|---|---|
| Metric | Last period | Why it matters |
| Non-GAAP Operating Income | 233% | This metric demonstrates Alnylam's operational efficiency and profitability from its core business. Investors will scrutinize its growth to assess the company's progress towards its long-term operating margin targets and sustainable profitability. |
| Total Global Net Product Revenues | $1.2 billion (74% y/y growth) | This is the overarching top-line revenue, reflecting the combined commercial success of all Alnylam's marketed products. It indicates the overall financial health and growth trajectory of the company's commercial portfolio. |
| Global TTR Net Revenues | $1.2 billion (74% y/y growth) | This metric is crucial as the TTR franchise, led by AMVUTTRA, is Alnylam's primary revenue driver. Its performance against the revised 2026 guidance, driven by first-line uptake and geographic expansion, will signal the durability of its growth. |
Last reported · 2026-07-30
| Key reported metrics | Rerating thresholds | Earnings results | ||||||
|---|---|---|---|---|---|---|---|---|
| Metric | Last period | Why it matters | What's needed for rerating | Rerating context | Earnings date | Actual reported | Hit target? | Notes |
| Non-GAAP Research & Development (R&D) Expenses | 0% | As a biopharmaceutical company, R&D expenses are critical for advancing Alnylam's pipeline, including key assets like zilebesiran for hypertension. While flat in the last period, investors will scrutinize these expenses for efficient investment in clinical trials and future growth drivers. | For Alnylam Pharmaceuticals to rerate higher, its Non-GAAP Research & Development (R&D) Expenses for the full year 2026 need to be efficiently managed within the range of $1.47 billion to $1.59 billion. This aligns with the company's stated target of investing approximately 30% of its projected 2026 revenues, which are guided between $4.9 billion and $5.3 billion. Achieving this while simultaneously demonstrating strong pipeline progress and positive clinical de-risking data from key assets is crucial. | Hitting this range demonstrates financial discipline and effective capital allocation towards innovation, crucial for justifying Alnylam's high valuation. Efficient R&D that yields successful pipeline advancements reinforces the long-term growth thesis, supports the 'Alnylam 2030' non-GAAP operating margin goals, and addresses concerns about rising costs impacting profitability. | $377 million (38% y/y increase) | Yes | Non-GAAP R&D expenses for Q2 2026 were $377 million, an increase of 38% compared to the prior year. The company stated that the remainder of its non-GAAP financial guidance remains unchanged, implying the full-year R&D expense guidance of $1.47 billion to $1.59 billion is still in effect. The Q2 run rate suggests the company is on track to manage R&D expenses within this target range for the full year. | |
| Net Product Revenues | 28% | Net Product Revenues directly reflect the sales performance of Alnylam's commercialized drugs, such as ONPATTRO, GIVLAARI, OXLUMO, and AMVUTTRA. Strong growth in this segment, particularly from the TTR franchise, is crucial for driving profitability and validating the company's commercial strategy. | For Q1 2026, Combined Net Product Revenues need to exceed analyst consensus of approximately $1.13 billion by at least 3%, coupled with TTR net product revenue demonstrating positive quarter-on-quarter growth (reversing the 'considerably lower' expectation compared to Q4 2025's $134 million growth), and reaffirming or raising the full-year 2026 guidance of $4.9 billion to $5.3 billion. | Exceeding Q1 revenue expectations and showing positive TTR quarter-on-quarter growth would signal stronger Amvuttra uptake and resilience against anticipated Q1 seasonality and international pricing adjustments. This would reinforce confidence in Alnylam's ability to achieve its ambitious 2026 revenue guidance and long-term 'Alnylam 2030' goals, justifying its premium valuation and mitigating competitive concerns. | $1.2 billion (74% y/y growth) | Partially | Combined net product revenues of $1.2 billion exceeded the analyst consensus of $1.13 billion by more than 3%. Global TTR net revenues showed positive quarter-on-quarter growth (13% vs Q1). However, the company lowered its full-year 2026 total net product revenue guidance to $4.7 billion to $5.1 billion, down from the original $4.9 billion to $5.3 billion. | |
| Total Revenue | 20% | Total Revenue is a fundamental indicator of Alnylam's overall financial performance and the market adoption of its diverse portfolio of RNAi therapeutics. Investors closely monitor this metric for sustained growth, reflecting successful commercialization and market expansion of its key products. | For Alnylam Pharmaceuticals (ALNY) to rerate higher, its Q1 2026 Total Revenue needs to exceed analyst consensus estimates, ideally surpassing $1.15 billion. This would represent a year-over-year growth rate of over 93.6% compared to Q1 2025's $594 million, demonstrating stronger-than-anticipated performance despite the company's cautious outlook for quarter-on-quarter TTR revenue growth. Additionally, the company needs to reaffirm its full-year 2026 net product sales guidance of $4.9 billion to $5.3 billion, with commentary suggesting confidence in achieving the higher end of this range. | Exceeding revenue expectations would alleviate investor concerns regarding near-term revenue choppiness, international pricing adjustments, and U.S. seasonality. This would reinforce confidence in the robust uptake of Amvuttra, Alnylam's key growth driver, and the company's ability to achieve its ambitious 'Alnylam 2030' goals and justify its current high valuation amidst competitive threats. | $1.319 billion (66.76% y/y growth) | No | Total revenue for Q2 2026 was $1.319 billion, which surpassed the $1.15 billion threshold. However, the year-over-year growth of 66.76% was below the 93.6% target. Furthermore, the company lowered its full-year 2026 total net product revenue guidance, failing to reaffirm or raise it. | |
Key QuestionsCan Alnylam's AMVUTTRA maintain robust first-line new patient starts and expand its prescriber base sufficiently to meet the revised 2026 TTR revenue guidance f
Can Alnylam's AMVUTTRA maintain robust first-line new patient starts and expand its prescriber base sufficiently to meet the revised 2026 TTR revenue guidance for the second half of the year, especially following the normalization of second-line demand?
- Question 2
How will the failure of eplontersen's CARDIO-TTRansform study impact the competitive landscape for ATTR cardiomyopathy, and will Alnylam's nucresiran TRITON-CM study design adaptations and superior knockdown profile reinforce its long-term TTR leadership potential?
- Question 3
Will the upcoming Phase I/II data readouts for key pipeline programs like ALN-6400 (HHT), ALN-HTT02 (Huntington's), and ALN-2232 (obesity) in the second half of 2026 demonstrate sufficient safety and efficacy to de-risk these assets and support Alnylam's long-term growth ambitions beyond the TTR franchise?
Earnings Transcript Summary
· 2026Q2 Earnings Call
| 3 Things Management Is Most Focused On | Call Takeaway & Tone | Prior Quarter'S Y/Y Growth By Segment | 3 Things Analysts Most Pressed On (And Mgmt Responses) | Revenue Segments |
|---|---|---|---|---|
| 3 Things Management Is Most Focused On1. **Establishing global leadership in TTR and building a durable franchise**: Management emphasized the strong performance of AMVUTTRA, particularly in the first-line setting, and its geographic expansion, including a new collaboration in China. They also expressed strong confidence in nucresiran despite competitive data. 2. **Growing through sustainable innovation**: Alnylam is focused on advancing its deep pipeline, initiating new Phase II trials (ALN-6400, mivelsiran), and leveraging AI collaborations for discovery, disease identification, and commercial execution. 3. **Scaling with discipline and agility to enable durable, profitable growth**: While lowering 2026 revenue guidance due to a better understanding of second-line demand normalization, management reiterated confidence in AMVUTTRA's long-term growth trajectory and the company's ability to achieve its Alnylam 2030 goals, driven by strong operating performance and cash generation. | Call Takeaway & ToneThe overall takeaway of the call was one of **cautious confidence**. Management acknowledged the disappointment of lowering 2026 revenue guidance due to a better understanding of second-line demand normalization for AMVUTTRA. However, they expressed strong conviction in the long-term growth trajectory of AMVUTTRA, driven by robust first-line uptake, expanding prescriber base, and a more favorable competitive landscape following the CARDIO-TTRansform study failure. The tone was optimistic regarding the company's deep pipeline, AI collaborations, and ability to achieve its Alnylam 2030 strategic goals, emphasizing scientific innovation and disciplined growth. | Prior Quarter'S Y/Y Growth By SegmentTotal net product revenues: 121% year-over-year growth. Global TTR net revenues: 153% year-over-year growth. U.S. TTR revenues: >230% year-over-year growth. Rare disease net revenue: 15% year-over-year growth. International TTR Revenue: 35% year-over-year growth. Collaboration revenue: 17% decrease year-over-year. Royalty revenue: 85% increase year-over-year. | 3 Things Analysts Most Pressed On (And Mgmt Responses)1. **Change in guidance and confidence in long-term growth**: Analysts questioned the revised 2026 guidance and its implications for the 25% CAGR target through 2030. Management responded by acknowledging the guidance adjustment but emphasized strong market fundamentals, accelerating first-line momentum, and the competitive landscape becoming more favorable with fewer branded competitors, reinforcing confidence in achieving long-term goals. 2. **Slower rate of second-line patients and timing of diagnosis/awareness efforts**: Analysts inquired about the normalization of second-line demand and how early diagnosis initiatives would impact first-line capture. Management explained that while second-line demand normalized after initial pent-up demand, first-line new patient starts are now driving 80% of category growth. They are intensifying investments in diagnosis-enabling initiatives to expand the treatable population and accelerate category growth. 3. **Impact of CARDIO-TTRansform study failure on commercial aspects (payers, combo use) and net price evolution**: Analysts asked if the negative CARDIO-TTRansform results would lead to payer pushback on combination therapy or impact AMVUTTRA's commercial standing. Management stated that CARDIO-TTRansform involved a different molecule and study design, and does not change AMVUTTRA's evidence or label. They do not expect payers to alter AMVUTTRA coverage, and physicians still have pathways for access. They also confirmed that the modest quarter-to-quarter net price decreases are expected to continue, aligning with mid-single-digit year-over-year net price decrease guidance. | Revenue SegmentsTotal global net product revenues: 74% year-over-year growth. Collaboration revenue: 23% decrease year-over-year. Royalty revenue: 79% increase year-over-year. Rare disease net revenue: 11% year-over-year growth. Global TTR net revenues: 89% year-over-year growth. U.S. TTR revenues: 114% year-over-year growth. Outside U.S. TTR revenues: 31% year-over-year growth. |
· 2025Q4 Earnings Call
| 3 Things Management Is Most Focused On | Call Takeaway & Tone | Prior Quarter'S Y/Y Growth By Segment | 3 Things Analysts Most Pressed On (And Mgmt Responses) | Revenue Segments |
|---|---|---|---|---|
| 3 Things Management Is Most Focused On1. Achieving global TTR leadership and building a durable TTR franchise: Management aims to lead the TTR market in revenue by 2030 and plans to launch nuceresiran for polyneuropathy in 2028 and cardiomyopathy in 2030. This is a core part of their 'Alnylam 2030' goals. 2. Growing through sustainable innovation: The company plans to deliver two or more transformative medicines beyond TTR with blockbuster potential, achieve RNAi delivery to 10 tissue types, and have a pipeline of over 40 clinical programs by 2030. They expect to invest approximately 30% of revenues in non-GAAP R&D to accelerate organic and selectively access external innovation. 3. Scaling with discipline and agility to drive sustained, profitable growth: This includes striving for over 25% revenue CAGR through 2030 and a non-GAAP operating margin of 30% across the period, potentially reaching mid-40s post-2030 if nuceresiran is successful due to lack of royalty obligations. | Call Takeaway & ToneThe overall takeaway of the call was highly positive and confident. Management emphasized a transformational 2025, marked by the landmark approval and blockbuster launch of Amvuttra for ATTR cardiomyopathy, significant pipeline advancements, and the achievement of sustainable GAAP profitability. The tone was optimistic, reinforced by ambitious 'Alnylam 2030' goals focusing on TTR leadership, sustainable innovation, and disciplined, profitable growth. Despite anticipated Q1 seasonality and potential future competition, management expressed strong confidence in Amvuttra's continued growth trajectory and the company's long-term financial and pipeline prospects. | Prior Quarter'S Y/Y Growth By SegmentFor Q3 2025: - Total net product revenues: 103% year-over-year growth. - Global TTR net revenues: 135% year-over-year growth. - U.S. TTR net revenues: 194% year-over-year growth. - Rare disease portfolio (GIVLAARI and OXLUMO): 14% year-over-year growth. - Collaboration revenue: Increased by $294 million compared to Q3 2024. - Royalty revenue: Doubled (100% increase) compared to Q3 2024. | 3 Things Analysts Most Pressed On (And Mgmt Responses)1. New patient adds and the mix of first-line Amvuttra versus tafamidis switches in 2026: Management (Tolga Tanguler) responded that the fundamentals drive confidence, citing improved first-line access, strengthening physician and patient preference, and continued category growth. 2. Choppiness in Q1 TTR franchise scripts and pricing dynamics, including new potential market entries and growth in Europe: Management (Tolga Tanguler and Jeff Poulton) stated they are well-positioned for access, with most patients having first-line access without step-through requirements and paying zero out-of-pocket. They expect a mid-single-digit net price decrease for Amvuttra in 2026, similar to 2025, and that Q1 seasonality is typical for the industry but not impacting underlying momentum. They also noted an expected $25 million reduction in Q1 international revenues due to Germany pricing alignment. 3. The potential impact of competitive silencer data on Amvuttra's label and commercial prospects: Management (Tolga Tanguler and Pushkal Garg) acknowledged the difficulty in assessing impact without seeing competitor data but emphasized the large and underserved category, suggesting new entrants could help drive diagnosis. They highlighted Amvuttra's strong position with rapid, deep, and sustained knockdown, robust clinical data, and quarterly dosing. Pushkal Garg expected the competitor's study to be positive but did not foresee a materially different label or effect size compared to Amvuttra's already broad label. | Revenue SegmentsFor Q4 2025: - Combined net product revenues: 121% year-over-year growth. - Rare disease portfolio (GIVLAARI and OXLUMO): 26% year-over-year growth. - Global TTR net revenues: 151% year-over-year growth. - U.S. TTR franchise: 222% year-over-year growth. - Outside U.S. TTR franchise: 47% year-over-year growth. For Full Year 2025: - Combined net product revenues: 81% growth compared to 2024. - Collaboration revenue: 8% growth compared with 2024. - Royalty revenue: 90% increase compared with last year. |
Transcript Tidbits
| About Expanding Eligible Market | About Competition | About The Broader Industry | Where Things Are Headed | Updates On Theme | Broader Themes Emerging | Bullish-Leaning Quotes (Short) | Bearish-Leaning Quotes (Short) |
|---|---|---|---|---|---|---|---|
| About Expanding Eligible MarketAMVUTTRA revenues exceeded $1 billion in a single quarter, representing an annual run rate of more than $4 billion, just 15 months into the ATTR cardiomyopathy launch. The company announced a collaboration with BeOne for exclusive commercialization and distribution rights for AMVUTTRA in Mainland China and Macau, subject to marketing authorization. First-line new patient starts are now responsible for about 80% of category growth in this accelerating market. Alnylam is further investing in broadening its AMVUTTRA prescriber base and supporting overall category growth. Strategic AI collaborations, including one with a large healthcare system in California, are aimed at supporting early identification of ATTR cardiomyopathy in routine care. The company initiated a Phase II trial of ALN-6400 in von Willebrand disease and a Phase II trial of mivelsiran in Down syndrome associated Alzheimer's disease. An estimated 80% of ATTR-CM patients remain untreated, and the company has added over 1,700 new prescribers since the launch of AMVUTTRA. For hereditary hemorrhagic telangiectasia (HHT), ALN-6400 targets an estimated 1.5 million patients globally, with about 70,000 addressable patients in the U.S. | About CompetitionThe negative outcome of the CARDIO-TTRansform study of eplontersen does not alter Alnylam's conviction in the TRITON-CM study for nucresiran. The company anticipates tafamidis U.S. loss of exclusivity in 2031, and AMVUTTRA is already challenging the 7-year incumbent for leadership share of new patient starts. Due to the CARDIO-TTRansform study top-line results, Alnylam now anticipates fewer branded ATTR-CM competitors in both the first-line and stabilizer progressive segments. Comparisons of TTR knockdown profiles suggest nucresiran has the potential for best-in-class knockdown, exceeding vutrisiran and eplontersen. There is no head-to-head data between different classes of medicines, but Alnylam has seen additive benefits of RNAi-mediated silencing on top of stabilizers in two studies (HELIOS-B and APOLLO-B). While some Medicare Advantage policies limit combination use, physicians continue to have pathways to pursue access when medically appropriate. | About The Broader IndustryThe ATTR cardiomyopathy category growth continues to accelerate, with approximately 80% of patients still untreated. The company noted that early second-line demand growth in 2025 benefited significantly from pent-up demand for a new therapy that has since normalized. The industry experiences typical Q1 seasonality, which impacted earlier revenue growth expectations. | Where Things Are HeadedAlnylam is lowering its 2026 total net product revenue guidance to $4.7 billion to $5.1 billion, and TTR revenue guidance to $4.2 billion to $4.5 billion, reflecting a better understanding of second-line demand normalization. Despite this, confidence in AMVUTTRA's growth trajectory is stronger than ever. The company's Alnylam 2030 strategy is anchored around establishing global leadership in TTR, growing through sustainable innovation, and scaling with discipline and agility. The projected launch for nucresiran in ATTR cardiomyopathy is 2030, and in hATTR polyneuropathy in 2028. Four key data readouts are anticipated in the second half of 2026: healthy volunteer data from the Phase I study of ALN-6400, initial results from the Phase II study of ALN-6400 in hereditary hemorrhagic telangiectasia, initial Phase I results of ALN-HTT02 for Huntington's disease, and initial Phase I data for ALN-2232 in obesity and weight management. Many more data readouts and pivotal trial starts are anticipated in 2027 and 2028, with plans to file 3 to 4 new INDs each year. Modest quarter-to-quarter decreases in net price for AMVUTTRA are expected for the second half of 2026, with a mid-single-digit net price decrease year-over-year. | Updates On ThemeRNA | Broader Themes EmergingAI strategy from discovery and evidence generation to disease identification, clinical practice, and commercial execution. | Bullish-Leaning Quotes (Short)AMVUTTRA revenues exceeded $1 billion in a single quarter, representing an annual run rate of more than $4 billion, just 15 months into the ATTR cardiomyopathy launch, a testament to both the commercial opportunity and Alnylam's execution. Our confidence in AMVUTTRA's growth trajectory has never been stronger. This outcome does not alter our conviction in the TRITON-CM study. We believe AMVUTTRA is uniquely positioned to address the needs of the growing ATTR-CM patient population. With median knockdown of 95% and low variability, over 99% of patients choosing nucresiran are expected to surpass this deep knockdown threshold. | Bearish-Leaning Quotes (Short)As Jeff will describe shortly, we are lowering our 2026 revenue guidance today to reflect a better understanding with hindsight of the first few quarters of our U.S. launch, specifically that early second-line demand growth in 2025 benefited significantly from pent-up demand for a new therapy that has since normalized. Guiding the market's expectations appropriately is important, and we didn't get it right with our original guidance. We own that. This normalization of second-line demand is the driver of the $200 million reduction in TTR guidance that we are announcing today. We expect that will continue for the second half. And if we were to show you that on a year-over-year basis, the way we had guided was mid-single-digit net price decrease year-over-year. |
| About Expanding Eligible Market | About Competition | About The Broader Industry | Where Things Are Headed | Updates On Theme | Broader Themes Emerging | Bullish-Leaning Quotes (Short) | Bearish-Leaning Quotes (Short) |
|---|---|---|---|---|---|---|---|
| About Expanding Eligible MarketAlnylam achieved a landmark approval of Amvuttra for ATTR cardiomyopathy in 2025, driving significant revenue growth. The company plans to launch nuceresiran in 2028 for polyneuropathy and 2030 for cardiomyopathy, aspiring to lead the TTR market in revenue by 2030. They aim to achieve RNAi delivery to 10 tissue types and have a pipeline of over 40 clinical programs by 2030. Amvuttra is being launched for ATTR cardiomyopathy in additional international markets throughout 2026. The company is investing in education, awareness, evidence generation, and diagnosis enablement to expand the ATTR cardiomyopathy category. New clinical programs include ALN-2232 for durable weight loss and visceral fat reduction, ALN-5288 for Alzheimer's disease and rare tauopathies, valesiran for cerebral amyloid angiopathy and Alzheimer's disease (a 'blue ocean opportunity'), ALN-HTT02 for Huntington's disease, and ALN-6400 for a wide range of bleeding disorders, with hereditary hemorrhagic telangiectasia affecting approximately 70,000 patients in the U.S.. | About CompetitionAlnylam's hereditary ATTR polyneuropathy business remains robust despite competition. Amvuttra approached parity with tafamidis in share of new starts in ATTR cardiomyopathy by the second quarter post-launch. The company acknowledges upcoming competitive silencer data, expecting the study to be positive with good knockdown. However, they hypothesize that the treatment effect size for competitors will not be materially different from what Alnylam has established with HELIOS-B, and do not foresee a competitor's label being materially different based on statistical significance in a subgroup. They believe additional entrants will help drive diagnosis and treatment rates, ultimately benefiting patients and expanding the category. | About The Broader IndustryThe ATTR cardiomyopathy category has seen approximately 40% volume CAGR over the past six years, yet the majority of patients remain untreated, indicating significant unmet need and growth potential. The industry experiences typical Q1 seasonality. GLP-1s have revolutionized the metabolic disease space, but Alnylam sees unmet needs in weight loss and A1c reduction without muscle loss and tolerability issues, which they aim to address with their pipeline. Additional market entrants are expected to help drive diagnosis and treatment rates across the industry. | Where Things Are HeadedAlnylam is focused on accelerating innovation and scaling impact, guided by their new 'Alnylam 2030' goals. These goals include achieving global TTR leadership, launching nuceresiran in 2028 (polyneuropathy) and 2030 (cardiomyopathy), delivering two or more transformative blockbuster medicines beyond TTR, achieving RNAi delivery to 10 tissue types, and expanding the pipeline to over 40 clinical programs by 2030. They expect to invest approximately 30% of revenues in non-GAAP R&D and aim for over 25% revenue CAGR and a non-GAAP operating margin of 30% through 2030, potentially reaching mid-40s post-2030 with nuceresiran. The company anticipates launching Amvuttra for ATTR cardiomyopathy in additional international markets throughout 2026. They expect clinical de-risking data in 2026 for ALN-6400, Huntington's, and ACVR1C programs. Combined non-GAAP R&D and SG&A expenses are projected to be between $2.7 billion and $2.8 billion in 2026, driven by increased investment in pivotal Phase 3 studies and early pipeline, as well as ongoing Amvuttra launch activities. | Updates On ThemeRNAi | Broader Themes EmergingInnovation in metabolic diseases (GLP-1s). | Bullish-Leaning Quotes (Short)Alnylam possesses a truly unique profile in the biotech industry, underpinned by our established and sustainable innovation engine, coupled with commercial excellence driving durable long-term growth. We achieved a landmark approval of Amvuttra for ATTR cardiomyopathy, and driven by the success of that launch, delivered nearly $3 billion in combined net product revenues, which was 81% growth compared to 2024. We can now officially declare that we have achieved GAAP profitability for the 2025 full year and expect to sustain profitability going forward. If nuceresiran is successful in demonstrating the best-in-class profile that we expect, we believe it would drive swift patient uptake and, given the lack of any royalty obligations for nuceresiran, potentially drive our operating margins to the mid-40s post 2030. Amvuttra is rapidly establishing itself as an important choice in new treatment starts. By just the second quarter post launch, Amvuttra approached parity with tafamidis in share of new starts based on available estimates. | Bearish-Leaning Quotes (Short)As expected, this will create a modest near-term impact on total TTR revenue in Q1. Modest quarter-over-quarter TTR growth in Q1 compared with the $111 million of U.S. quarterly growth achieved in Q4 due to fewer product shipping weeks in Q1 and the expected impact of annual insurance reauthorizations. Collaboration and royalty revenue guidance range is $400 million to $500 million, representing a decrease of 38% compared to 2025 at the midpoint of the guidance range, driven by the one-time $300 million zalesiran development milestone achieved in 2025 that will not recur this year. My hypothesis would be I do not see any reason why the treatment effect size would be any different than what we have already established in HELIOS-B. |
Notes
| Date | Comment | Comment Type | Comment Sentiment | Link | Price Reaction |
|---|---|---|---|---|---|
| 2026-02-12 | Alnylam reported strong 2025 results, achieving GAAP profitability and nearly $3 billion in revenue, driven by Amvuttra's successful launch. They outlined ambitious 2030 goals for TTR leadership and pipeline expansion. However, a cautious Q1 2026 TTR revenue outlook, citing international pricing and U.S. seasonality, and projected mid-single-digit Amvuttra net price declines, likely contributed to the stock's -2.45% return (underperforming SPY) post-earnings. | Earnings Transcript | Neutral | -2.45% (vs SPY: -1.13%) | |
| 2026-07-30 | Alnylam reported strong Q2 AMVUTTRA sales exceeding $1 billion, but lowered 2026 revenue guidance due to normalized second-line demand. Despite this, the company expressed strong confidence in AMVUTTRA's first-line growth (80% of new starts) and nucresiran's potential, especially after a competitor's trial failure. The market reacted negatively, with ALNY stock dropping 28.30% (underperforming SPY), indicating significant concern over the guidance reduction. | Earnings Transcript | Mixed | -28.30% (vs SPY: -32.17%) |
Upcoming Events
| Catalyst ID | Estimated Timing | Estimated Date Start | Estimated Date End | Catalyst | Why It Matters | Ticker Or Theme Specific | Transcript Date | Source Type |
|---|---|---|---|---|---|---|---|---|
| ALNY_42172ed3 | in October | 2026-10-01 | 2026-10-31 | Presentation of initial Phase I results of ALN-HTT02 in patients with Huntington's disease at EHDN. | Positive safety and efficacy data (e.g., >50% huntingtin knockdown) would de-risk this program and could significantly impact the long-term growth prospects and investor sentiment for ALNY's neuroscience pipeline. | Ticker | 2026-07-30 | earnings_transcript |
| ALNY_e966b7db | Q4 2026 for decision, late 2026 or early 2027 for launch | 2026-10-01 | 2027-03-31 | Potential U.S. regulatory approval for cemdisiran in generalized myasthenia gravis, a partnered product with Regeneron. | Approval would enable commercialization, leading to potential milestone payments and royalties for Alnylam, contributing to collaboration and royalty revenue. | Ticker | 2026-02-12 | earnings_transcript |
| ALNY_1f8d0ad4 | second half of the year | 2026-07-01 | 2026-12-31 | Release of Phase 1 clinical data for ALN-HTT02 (Huntington's disease program). | Data on huntingtin protein lowering and safety are crucial for de-risking this program, which targets a devastating disease with no approved therapies, potentially accelerating its development and impacting long-term valuation. | Ticker | 2026-02-12 | earnings_transcript |
| ALNY_6acd0085 | second half of the year | 2026-07-01 | 2026-12-31 | Release of Phase 1 clinical data for ALN-2232 (ACVR1C targeting for obesity & weight management). | Positive data would de-risk the program, demonstrating its potential for durable weight loss and addressing unmet needs in the overweight/obesity and diabetes space, impacting long-term valuation. | Ticker | 2026-02-12 | earnings_transcript |
| ALNY_5d72b867 | H2 2026 | 2026-07-01 | 2026-12-31 | Readout of Phase 3 CARDIO-TTRansform study results for Ionis Pharmaceuticals' eplontersen in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). | Positive results could introduce a new competitive TTR silencer into the ATTR-CM market, potentially impacting Amvuttra's market share, pricing dynamics, and overall TTR franchise growth. | Theme | 2026-02-12 | earnings_transcript |
| ALNY_94ae948c | second half of the year | 2026-07-01 | 2026-12-31 | Release of Phase 1 and 2 clinical data from the ALN-6400 program (targeting plasminogen for bleeding disorders). | Positive data would de-risk the program, supporting its 'pipeline-in-a-product' potential and future development in a range of bleeding disorders, impacting long-term valuation. | Ticker | 2026-02-12 | earnings_transcript |