The market expects Alnylam Pharmaceuticals (ALNY) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to b ...

Alnylam Pharmaceuticals (ALNY) shares rallied 8.5% in the last trading session to close at $243.27. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 6% loss over the past four weeks.The rise in share price came after President Trump announced a 90-day pause on his sweeping tariffs against non-retaliating countries.This RNA interference drug developer is expected to post quarterly loss of $0.55 per share in its ...

Dublin, March 28, 2025 (GLOBE NEWSWIRE) -- The "Innovation Insights: siRNA gene silencing" report has been added to ResearchAndMarkets.com's offering. In terms of deals, there have been 334 deals totaling US$107 billion in the siRNA gene silencing sector. The United States and Ireland stand out with two major M&A deals worth $54.9 billion. The highest deal volume was observed in 2023, while the highest deal value was seen in 2020. The slight decline in 2021, followed by a slight increase in 2022, may indic ...

The U.S. Food and Drug Administration on Thursday approved Alnylam Pharmaceuticals Inc.'s ALNY supplemental application for Amvuttra (vutrisiran).The drug treats adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis, or ATTR-CM, to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits.ATTR-CM is a rare heart condition where a protein called transthyretin (TTR) misfolds and deposits in the heart, causing it to stiffen and potentia ...

Alnylam Pharmaceuticals (ALNY) shares soared 11.8% in the last trading session to close at $283.34. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 1% gain over the past four weeks.The sudden rise in the stock price can be attributed to the FDA approval of Alnylam's regulatory filing seeking the label expansion of its lead drug, Amvuttra (vutrisiran), for treating the cardiomyopathy of wild-type or hereditary transthyretin-mediat ...

Waiting is often the most frustrating part of biotech investing, as the stocks can drift without clear positive drivers, and such has been the case with Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY ) for much of the past year, withAnalyst’s Disclosure: I/we have a beneficial long position in the shares of ALNY, RHHBY either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alph ...

Core Viewpoint - Alnylam Pharmaceuticals received FDA approval for the label expansion of its lead drug, Amvuttra, to treat cardiomyopathy associated with transthyretin-mediated amyloidosis, marking a significant milestone as it becomes the first and only approved therapy for both ATTR-CM and hATTR-PN in adults [1][3][4] Company Overview - Amvuttra is an RNAi therapeutic previously approved for treating polyneuropathy associated with transthyretin-mediated amyloidosis in adults [2] - The drug generated sales of $970.5 million in 2024, reflecting a 74% year-over-year increase, driven by new patient treatments and switches from Onpattro [11] Clinical Data and Efficacy - The approval is based on positive results from the pivotal phase III HELIOS-B study, which met all primary and secondary endpoints with statistical significance [4] - Amvuttra demonstrated a reduction in mortality and cardiovascular events, while improving functional capacity, quality of life, and heart failure symptoms in ATTR-CM patients [6] Safety Profile - The safety profile of Amvuttra in the HELIOS-B study was consistent with its known profile for treating hATTR amyloidosis, with similar rates of adverse events between Amvuttra and placebo groups [7] Market Potential - Amvuttra enjoys near-universal insurance coverage for hATTR-PN, and similar coverage is anticipated for ATTR-CM, supported by strong clinical data [8] - Regulatory applications for Amvuttra's ATTR-CM indication are under review in the EU, Brazil, and Japan, with further applications expected in 2025 [9][10] Growth Prospects - Alnylam believes that Amvuttra has the potential to become the new standard of care for ATTR-CM, which could significantly expand the eligible patient population and drive substantial growth for the company [10]

Core Insights - The U.S. FDA approved Alnylam Pharmaceuticals' supplemental application for Amvuttra to treat adults with ATTR-CM, aiming to reduce cardiovascular mortality, hospitalizations, and urgent heart failure visits [1][2]. Group 1: Approval and Indications - Amvuttra is now the first and only FDA-approved therapy for both ATTR-CM and hATTR-PN in adults [2]. - ATTR-CM affects approximately 150,000 individuals in the U.S. and over 300,000 globally [2]. Group 2: Clinical Trial Results - The approval is based on the HELIOS-B Phase 3 clinical trial, which showed statistical significance on all 10 primary and secondary endpoints compared to placebo [3]. - Amvuttra reduced the risk of all-cause mortality and recurrent cardiovascular events by 28% during a treatment period of up to 36 months [3]. - Mortality was significantly reduced by 36% through 42 months in a secondary endpoint analysis [4]. - In the monotherapy population, Amvuttra reduced the risk of all-cause mortality and recurrent cardiovascular events by 33% and the risk of mortality by 35% through 42 months [4]. Group 3: Market Dynamics and Financials - Amvuttra in hATTR-PN is covered by insurers for around 99% of patients, with most paying nothing out-of-pocket, and similar coverage is expected for ATTR-CM [5]. - In 2024, Amvuttra sales reached $970.45 million, an increase from $557.84 million the previous year [6]. Group 4: Future Prospects - Marketing authorization applications based on HELIOS-B data are under review by several global health agencies, including the European Medicines Agency and the Brazilian Health Regulatory Agency [6]. - Alnylam plans to proceed with additional global regulatory submissions for vutrisiran in 2025 [6]. Group 5: Stock Performance - Following the approval news, ALNY stock rose by 8.46% to $274.98 [7].

Core Viewpoint - Alnylam Pharmaceuticals is focused on developing RNAi-based therapeutics, with a strong pipeline and increasing sales of marketed drugs driving significant stock price growth [1][2]. Marketed Drug Portfolio - Alnylam's lead drug, Amvuttra, generated sales of $970.5 million in 2024, reflecting a 74% year-over-year increase, primarily due to new patient starts and switches from Onpattro [4]. - The combined sales of Givlaari and Oxlumo reached $422.9 million in 2024, up 29% year-over-year [5]. - Alnylam collaborates with Novartis to market Leqvio, which is approved in over 100 countries and is undergoing late-stage studies for further label expansion [6]. Pipeline Development Programs - Alnylam is seeking label expansion for Amvuttra to treat ATTR amyloidosis with cardiomyopathy, with a decision expected from the FDA on March 23, 2025 [7][8]. - The company is developing cemdisiran in partnership with Regeneron for various indications, with exclusive rights granted to Regeneron for certain developments [9]. - Alnylam has regained full rights to mivelsiran for Alzheimer's disease and expects to report interim data in the second half of 2025 [10]. - Collaboration with Roche on zilebesiran has shown promising results in phase II studies, with further studies planned for 2025 [11][12]. Growth Potential - Successful development and commercialization of the pipeline candidates are expected to significantly boost Alnylam's growth [13].

Core Viewpoint - Alnylam Pharmaceuticals reported a strong performance in Q4 2024, with adjusted earnings surpassing expectations and significant revenue growth driven by product sales and collaborations [1][2][15]. Financial Performance - Adjusted earnings for Q4 2024 were 6 cents per share, compared to a loss of 21 cents expected by analysts and a loss of 77 cents in the same quarter last year [1]. - Total revenues reached $593.2 million, exceeding the Zacks Consensus Estimate of $570 million and reflecting a 35% increase from $439.7 million in the prior year [2]. - Net product revenues were $450.8 million, a 30% increase year over year, driven by strong demand for Amvuttra, Givlaari, and Oxlumo [3]. Collaboration Revenues - Revenues from collaborators amounted to $106.9 million, a 40% increase from the previous year, primarily due to collaborations with Regeneron and Novartis [4]. Product Sales - Amvuttra generated sales of $286.5 million in Q4 2024, up 63% year over year, and exceeded the consensus estimate of $280 million [11]. - Givlaari recorded sales of $64.6 million, a 9% increase year over year, although it missed the consensus estimate of $69 million [12]. - Oxlumo achieved sales of $43.6 million, reflecting a 33% year-over-year increase, but fell short of the consensus estimate of $44.8 million [12]. Expenses - Adjusted R&D expenses rose 3% year over year to $259.5 million, driven by increased clinical study costs [13]. - Adjusted SG&A expenses increased 39% year over year to $244.3 million, mainly due to heightened marketing efforts for Onpattro and Amvuttra [13]. Cash Position - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $2.69 billion, down from $2.78 billion as of September 30, 2024 [14]. Full-Year Results - For the full year 2024, total revenues were $2.25 billion, up from $1.83 billion in 2023, and the company reported a loss of 2 cents per share, an improvement from a loss of $1.61 in 2023 [15]. 2025 Financial Guidance - Alnylam expects net product revenues for key products to be between $2.05 billion and $2.25 billion in 2025, with collaboration revenues projected between $650 million and $750 million [17]. Pipeline Updates - Alnylam is seeking label expansion for Amvuttra to treat ATTR amyloidosis with cardiomyopathy, with a decision from the FDA expected on March 23, 2025 [18].