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Alnylam yanks Amvuttra TV ad following FDA letter
Seeking Alpha· 2025-10-02 18:58
Alnylam Pharmaceuticals (NASDAQ:ALNY) has pulled a television ad for its drug Amvuttra (vutrisiran) after the U.S. FDA determined the spot was misleading. Amvuttra is approved for two heart conditions, hereditary transthyretin-mediated amyloidosis (ATTR-CM) and polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN). ...
Can Alnylam's Broader Portfolio Ease Its Dependence on Amvuttra?
ZACKS· 2025-10-01 16:05
Key Takeaways Amvuttra drives Alnylam's top line through expanded label and as patients switch from Onpattro.Givlaari, Oxlumo, and royalties from Leqvio add incremental revenues and global growth potential.Rare disease drugs delivered $236.8M in H1 2025 revenues, up 16% year over year.Alnylam Pharmaceuticals’ (ALNY) primary top-line driver is its newest drug, Amvuttra (vutrisiran), which is approved in the United States and the EU for treating the polyneuropathy of hereditary transthyretin-mediated (hATTR) ...
Alnylam Pharmaceuticals, Inc. (ALNY) Reports $492M Amvuttra Sales, Raises 2025 Revenue Guidance
Yahoo Finance· 2025-09-30 16:33
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]
Why Alnylam Pharmaceuticals (ALNY) is a Top Momentum Stock for the Long-Term
ZACKS· 2025-09-24 14:51
Taking full advantage of the stock market and investing with confidence are common goals for new and old investors, and Zacks Premium offers many different ways to do both.The popular research service can help you become a smarter, more self-assured investor, giving you access to daily updates of the Zacks Rank and Zacks Industry Rank, the Zacks #1 Rank List, Equity Research reports, and Premium stock screens.Zacks Premium also includes the Zacks Style Scores. What are the Zacks Style Scores? The Zacks Styl ...
Alnylam Q1 Earnings Beat Estimates, Product Revenues Rise Y/Y
ZACKS· 2025-05-02 15:55
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].
Alnylam Pharmaceuticals Presents 'Convincing Multi-Billion Dollar Opportunity': Analyst Upgrades Stock
Benzinga· 2025-03-24 18:08
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]