Alnylam Pharmaceuticals is set to invest $250m in the expansion of its facility in Norton, Massachusetts, US, to meet the growing global demand for RNA interference (RNAi) therapeutics. This is claimed to become the first fully dedicated small-interfering RNA (siRNA) enzymatic-ligation manufacturing facility. The facility expansion is intended to increase capacity, lower production expenses, and enable support for future medicine launches from the company’s development pipeline. As part of this, the co ...

Core Insights - The top 20 global biopharmaceutical companies saw a 4% increase in combined market capitalisation from $3.7 trillion on June 30, 2025, to $3.8 trillion on September 30, 2025, despite challenges from tariffs and drug pricing pressures [1] Company Performances - UCB experienced the largest market capitalisation growth of 40.9%, reaching $59.8 billion in Q3 2025, driven by the competitive positioning of its drug Bimzelx in hidradenitis suppurativa [2] - Alnylam Pharmaceuticals recorded a 40.6% increase in market capitalisation, attributed to strong sales of its RNAi therapeutic Amvuttra, which saw a 59% quarter-on-quarter increase in global sales to $492 million in Q2 2025 [3] - AbbVie reported a 24.7% rise in market capitalisation, bolstered by its $2.1 billion acquisition of Capstan Therapeutics and plans to invest $195 million in a new manufacturing facility in North Chicago [4] - Johnson & Johnson's market capitalisation grew by 21.5%, supported by a 5.8% sales growth in Q2 and FDA approval of its monoclonal antibody Tremfya for paediatric patients [5]

Core Insights - Alnylam Pharmaceuticals reported Q3 2025 earnings of $2.90 per share, exceeding the Zacks Consensus Estimate of $1.67, primarily due to increased revenues from Amvuttra sales [1][11] - Total revenues reached $1.25 billion, surpassing the Zacks Consensus Estimate of $1.02 billion, marking a 149% year-over-year increase [2][11] - Despite strong earnings and revenue growth, ALNY shares fell by 6.7% due to investor concerns over an external inquiry into commercial practices [3] Revenue Breakdown - Net product revenues were $851.1 million, a 103% increase year over year, driven by demand for Amvuttra, Givlaari, and Oxlumo [3][9] - Collaboration revenues totaled $351.7 million, boosted by a $300 million milestone payment from Roche related to the ZENITH phase III clinical study [4][11] - Royalty revenues increased by 98% year over year to $46.2 million [5] Product Performance - Amvuttra sales reached $685.3 million, a 165% increase, driven by demand from patients with ATTR amyloidosis and cardiomyopathy [8][11] - Onpattro sales were $39.1 million, down 22% year over year, missing estimates [6] - Givlaari recorded sales of $73.9 million, a 4% increase, but also missed estimates [9] Financial Guidance - Alnylam raised its 2025 net product revenue guidance to $2.95-$3.05 billion from $2.65-$2.80 billion [16] - Collaboration and royalty revenue guidance remains at $650-$750 million, while adjusted R&D and SG&A expenses are now expected to be $2.15-$2.20 billion [17] Research and Development - Adjusted R&D expenses rose 23% year over year to $310.1 million, driven by costs associated with the ZENITH study and other clinical trials [13] - Adjusted SG&A expenses increased 35% year over year to $262.6 million, primarily due to higher employee compensation and marketing investments for Amvuttra [14]

Core Insights - Alnylam Pharmaceuticals has withdrawn a television advertisement for its drug Amvuttra after the U.S. FDA deemed the advertisement misleading [2] - Amvuttra is approved for treating two specific heart conditions: hereditary transthyretin-mediated amyloidosis (ATTR-CM) and polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) [3] Company Summary - The company faced regulatory scrutiny from the U.S. FDA regarding its advertising practices [2] - Amvuttra is positioned in the market for treating serious health conditions related to amyloidosis [3]

Core Insights - Alnylam Pharmaceuticals' primary revenue driver is its newest drug, Amvuttra, approved for treating hATTR amyloidosis and ATTR-CM, with strong uptake from new patients and switches from Onpattro [1][10] Product Portfolio - Alnylam markets several products in rare disease and cardiovascular markets, contributing incremental revenues to the top line [2] - Givlaari is approved for acute hepatic porphyria in adults and adolescents, with strong uptake and plans for regulatory submissions in additional regions through 2025 [3] - Oxlumo is approved for primary hyperoxaluria type 1, with an expanded label for lowering urinary and plasma oxalate levels, enhancing its growth potential [4] - Leqvio, in collaboration with Novartis, treats hypercholesterolemia and has an expanded label for high-risk cardiovascular patients, generating royalties for Alnylam [5] Financial Performance - In the first half of 2025, Alnylam generated $236.8 million in net product revenues from its rare disease portfolio, reflecting a 16% year-over-year increase, with expectations for sustained growth and diversified revenue streams [6][10] Competitive Landscape - Amvuttra faces increasing competition in the ATTR-CM market from therapies like Pfizer's Vyndaqel/Vyndamax and BridgeBio's Attruby, which are already approved and competing for market share [7] - Pfizer's Vyndaqel family generated $3.1 billion in revenues in the first half of 2025, a 27% increase year-over-year, driven by rising diagnosis and treatment rates [8] - BridgeBio's Attruby, approved in late 2024, generated $108.2 million in sales in the first half of 2025, with significant uptake reported [9]

Company Overview - Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is a leading biotech company specializing in RNA interference (RNAi) therapeutics, focusing on treatments for rare and prevalent diseases, particularly transthyretin amyloidosis (ATTR) [1] Financial Performance - In Q2 2025, Amvuttra sales reached $492 million, exceeding the consensus estimate of $350 million, driven by expanded use for ATTR cardiomyopathy [2] - The company raised its 2025 revenue guidance for Amvuttra and Onpattro to $2.18–$2.28 billion, with total projected net revenues between $2.65–$2.8 billion [2] - Alnylam's market valuation has surpassed $50 billion, with shares increasing over 15% recently [2] Product Insights - Amvuttra's subcutaneous administration may improve patient adherence compared to oral competitors, priced at $476,000 annually for cardiomyopathy, and is increasingly recognized as a first-line therapy [3] - Commercial and Medicare payers are approving Amvuttra treatment without requiring prior use of competitor products, supporting sustainable growth in the U.S. market [3] Pipeline Development - Alnylam is advancing its pipeline, including RNAi therapeutics for cardiovascular diseases, such as zilebesiran for hypertension [4] - The company presented 12-month HELIOS-B Phase 3 data demonstrating sustained benefits of Amvuttra in treating ATTR cardiomyopathy [4] - Alnylam joined the Alliance for Genomic Discovery in September 2025 to leverage large-scale genomic datasets for accelerating target discovery and innovation in gene silencing therapies [4]

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market strategies and confidence [1] - The Zacks Style Scores are designed to complement the Zacks Rank, helping investors identify stocks likely to outperform the market in the short term [2] Zacks Style Scores Overview - Stocks are rated from A to F based on value, growth, and momentum characteristics, with A being the highest score [3] - The Style Scores are categorized into four types: Value Score, Growth Score, Momentum Score, and VGM Score [3][4][5][6] Value Score - Focuses on identifying undervalued stocks using financial ratios such as P/E, PEG, and Price/Sales [3] Growth Score - Concentrates on a company's financial health and future growth potential, analyzing projected and historical earnings, sales, and cash flow [4] Momentum Score - Targets stocks with upward or downward price trends, utilizing recent price changes and earnings estimate revisions to identify buying opportunities [5] VGM Score - Combines Value, Growth, and Momentum Scores to provide a comprehensive assessment of stocks, aiding in the selection of the most attractive investment opportunities [6] Zacks Rank Integration - The Zacks Rank uses earnings estimate revisions to identify stocks with the highest potential returns, with 1 (Strong Buy) stocks historically achieving an average annual return of +23.64% since 1988 [7][8] - Investors are encouraged to focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal investment success [9] Company Spotlight: Alnylam Pharmaceuticals - Alnylam Pharmaceuticals is a biopharmaceutical company specializing in RNA interference therapeutics, with a pipeline targeting genetic, cardio-metabolic, and hepatic infectious diseases [11] - The company has received multiple FDA approvals for its products, including Onpattro, Givlaari, Oxlumo, and Amvuttra, addressing various medical conditions [11] - Currently, Alnylam has a Zacks Rank of 3 (Hold) and a VGM Score of B, with a strong Momentum Style Score of A, indicating potential for upward movement [12][13]

Core Viewpoint - Alnylam Pharmaceuticals reported better-than-expected financial results for Q1 2025, with adjusted losses narrower than estimates and significant revenue growth driven by strong product sales, particularly for Amvuttra [1][2][16]. Financial Performance - The company reported total revenues of $594.2 million, exceeding the Zacks Consensus Estimate of $588.2 million, and reflecting a 20% year-over-year increase [2]. - Net product revenues reached $468.5 million, up 28% year-over-year, primarily due to increased demand for Amvuttra, Givlaari, and Oxlumo [2][6]. - Net revenues from collaborators were $99.2 million, down 16% from the previous year, largely due to a prior milestone payment from Roche [3]. Product Sales - Amvuttra generated sales of $310 million, a 59% increase year-over-year, and surpassed estimates [6]. - Givlaari recorded sales of $67 million, a 15% increase year-over-year, but slightly missed estimates [7]. - Oxlumo's sales were $42.1 million, remaining flat year-over-year and missing estimates [7]. Expenses and Cash Position - Adjusted R&D expenses were approximately $241.3 million, remaining stable year-over-year [10]. - Adjusted SG&A expenses increased by 12% to $207 million, driven by marketing efforts for Amvuttra [11]. - Cash, cash equivalents, and marketable securities totaled $2.63 billion as of March 31, 2025, down from $2.69 billion at the end of 2024 [11]. Guidance and Collaborations - The company reiterated its 2025 financial guidance, expecting net product revenues between $2.05 billion and $2.25 billion, and collaboration revenues between $650 million and $750 million [12]. - Alnylam is advancing several collaborations, including with Regeneron and Roche, which are expected to enhance its product pipeline and revenue streams [13][14][17]. Market Performance - Year-to-date, Alnylam's stock has gained 8.4%, outperforming the industry, which has seen a decline of 1.8% [8].

Core Insights - The U.S. FDA has approved Alnylam Pharmaceuticals' supplemental application for Amvuttra, making it the first and only therapeutic approved for treating ATTR-CM and hATTR-PN in adults [1][2] Group 1: Drug Approval and Indication - Amvuttra is indicated for adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), aimed at reducing cardiovascular mortality, hospitalizations, and urgent heart failure visits [1][2] - ATTR-CM is characterized by the misfolding of transthyretin (TTR) protein, leading to heart stiffness and potential heart failure [2] Group 2: Market Opportunity and Analyst Insights - JPMorgan has upgraded Alnylam to an Overweight rating, raising the price target from $280 to $328, citing a significant multi-billion dollar opportunity for Amvuttra in TTR amyloidosis [3][4] - Analyst Jessica Fye projects Amvuttra sales in cardiomyopathy to reach approximately $81 million in 2025, an increase from the previous estimate of $79 million [3] Group 3: Stock Performance - Following the news, ALNY stock rose by 3.50%, reaching $293.25 [5]