Latest news with #Amvuttra
Yahoo
06-08-2025
- Business
- Yahoo
Novo Nordisk to advance ATTR amyloidosis mAb to Phase III
Novo Nordisk will advance its acquired ATTR amyloidosis with cardiomyopathy monoclonal antibody (mAb) to Phase III trials. The Danish pharma said that the Phase II trial of coramitug (PRX004), an mAb designed to deplete amyloid deposits, was 'successfully completed'. The trial investigated the efficacy and safety of once-monthly intravenous (IV) doses of coramitug compared to placebo in 105 patients with ATTR-cardiomyopathy. The primary endpoints of the trial included the functional endpoints of a six-minute walking test (6MWT), as well as a change in NT-proBNP after 52 weeks of treatment. While data has not yet been released, Novo Nordisk said results will be available at a medical conference later this year. However, the drugmaker confirmed its intention to initiate a Phase III trial of the drug in ATTR with cardiomyopathy before the end of 2025 in its Q2 2025 earnings call on 6 August. The news will be a welcome financial development for Prothena Corporation after the drug was acquired from them by Novo Nordisk in July 2021. Under the agreement, Prothena is eligible to receive up to $1.2bn upon achievement of clinical development and sales milestones, including the $100m earned to date. While NovoNordisk stocks have dropped on 6 August, in part due to the Q2 and H1 earnings announcement, Prothena's stock has risen slightly on the news, up from $7.03 at market close on 5 August to $7.45 at market open on 6 August – a 5.97% rise. Prothena's CEO Dr Gene Kinney said: 'We are excited by Novo Nordisk's decision to advance coramitug into Phase III development. There remains a significant unmet need in patients with ATTR amyloidosis with cardiomyopathy, who are at high risk for early mortality and significant morbidity due to amyloid deposition in vital organs.' ATTR successes and failures In May 2025, Prothena faced a trial setback after a Phase III study of birtamimab in patients with amyloid light-chain (AL) amyloidosis missed its primary endpoint. During the same month, Intellia Therapeutics' stock crashed after a serious adverse event (AE) in a Phase III trial of its ATTR cardiomyopathy gene therapy. Despite this event, trials of the therapy are ongoing. US biopharma Alnylam is celebrating a recent win, however, after its ATTR cardiomyopathy drug Amvuttra (vutrisiran) gained approval by the European Commission on 11 June. This came three months after the therapy got the green light from the US Food and Drug Administration (FDA) in March 2025. Other approved therapies include Pfizer's Vyndamax (tafamidis) and BridgeBio Pharma's Attruby (acoramidis). After the EC approval of Amvuttra, GlobalData cardiovascular and metabolic diseases analyst Costanza Alciati said the approval marked a change in the treatment paradigm for these patients, with therapies such as coramitug and ALXN2220 also set to have an impact. "Novo Nordisk to advance ATTR amyloidosis mAb to Phase III " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
03-08-2025
- Business
- Yahoo
Alnylam's Amvuttra Makes Powerful Entrance, Eyes First-Line Dominance
Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) reported upbeat second-quarter earnings and 2025 guidance on Thursday. The company reported a second-quarter 2025 adjusted earnings of 32 cents, down from 56 cents a year ago. Analysts estimated a loss of 79 cents. The company reported quarterly sales of $773.69 million, up 17% year over year, beating the consensus of $638.55 Pharmaceuticals achieved global net product revenues for Amvuttra and Onpattro for the second quarter of $492 million and $53 million. The company achieved global net product revenues for Givlaari and Oxlumo for the second quarter of $81 million and $47 million. Alnylam raised its fiscal 2025 sales guidance from $2.7 billion-$3 billion to $3.3 billion-$3.55 billion compared to the consensus of $2.89 billion. Chardan Research and William Blair have both issued positive outlooks on Alnylam following the second-quarter results. Chardan Research stated that the launch of Amvuttra for ATTR-CM (Transthyretin Amyloid Cardiomyopathy) is off to an exceptionally strong start. ATTR-CM, or transthyretin amyloid cardiomyopathy, is a rare and often underdiagnosed form of heart failure. The company achieved approximately 1,400 ATTR-CM Patients on Amvuttra (vutrisiran) as of June 30, 2025, resulting in an approximately $150 million step-up in revenue. View more earnings on ALNY In March, the U.S. Food and Drug Administration on Thursday approved Amvuttra (vutrisiran) in adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis, or ATTR-CM. Chardan analyst Keay Nakae on Thursday wrote, 'We believe this speaks volumes about management confidence in the near-term launch progression. Commercially we believe that the totality of the data leaves Amvuttra well positioned to achieve significant market share as 1st line therapy.' Chardan reiterated the Buy rating, while raising the price forecast from $325 to $400. William Blair on Thursday wrote, 'We believe that Alnylam is the premier siRNA therapeutics company, and with the P5x25 corporate strategy intact, the company is on track to achieve profitability by the end of 2025 and become a fully sustainable biotech growth story.' Various analysts have reacted positively to Alnylam's performance, with several firms reiterating or maintaining their Buy or Overweight ratings and significantly raising their price forecasts. Morgan Stanley maintained an Equal-Weight rating, increasing its price forecast from $312 to $405. Piper Sandler and Barclays both maintained Overweight ratings, with Piper Sandler raising its forecast from $304 to $449, and Barclays increasing its target from $329 to $460. Raymond James reiterated an Outperform rating, boosting its price forecast from $370 to $424. Wells Fargo maintained an Equal-Weight rating, raising its price forecast from $333 to $395. Canaccord Genuity held a Buy rating, raising its forecast from $390 to $415, while UBS also maintained a Buy rating, notably increasing its price forecast from $403 to $550. Price Action: ALNY stock is trading higher by 1.56% to $398.36 at last check Friday. Read Next:Photo via Shutterstock Latest Ratings for ALNY Date Firm Action From To Mar 2022 Citigroup Initiates Coverage On Buy Feb 2022 Morgan Stanley Maintains Overweight Feb 2022 SVB Leerink Maintains Market Perform View More Analyst Ratings for ALNY View the Latest Analyst Ratings Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? ALNYLAM PHARMACEUTICALS (ALNY): Free Stock Analysis Report This article Alnylam's Amvuttra Makes Powerful Entrance, Eyes First-Line Dominance originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
01-08-2025
- Business
- Yahoo
Alnylam reaches new highs on strong sales of closely watched rare disease drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Dive Brief: Sales of an Alnylam Pharmaceuticals rare disease medicine substantially outpaced Wall Street expectations in the drug's first full quarter since U.S. regulators expanded its use, lifting the biotechnology company's market value to new highs on Thursday. According to Alnylam, sales of the drug, called Amvuttra and sold for two types of transthyretin amyloidosis, or ATTR, reached $492 million between April and June, well above consensus estimates of about $350 million. About $150 million of that total was attributed to patients with the 'cardiomyopathy' form of the disease that regulators cleared Amvuttra for in March. Some 1,400 people were on therapy at the end of the quarter, Alnylam said. Alnylam also hiked its 2025 financial projections by hundreds of millions of dollars, guiding between $2.18 billion and $2.28 billion in net revenue from Amvuttra and Onpattro, its other transthyretin amyloidosis drug, compared to the previous $1.6 billion to $1.73 billion range. Alnylam now expects $2.65 billion to $2.8 billion in total net revenues. Company shares climbed by more than 15%, taking Alnylam's market value past $50 billion. Dive Insight: Alnylam has for years been among biotech's most valuable companies. But it has never been consistently profitable, and is banking on Amvuttra to change that. A March expansion into ATTR cardiomyopathy, a progressive condition that causes heart failure, hospitalizations and death, was a vital step. ATTR cardiomyopathy is believed to be more common than the 'polyneuropathy' form Amvuttra was first cleared to treat in 2022. Sales of the leading cardiomyopathy treatment, Pfizer's tafamidis, topped $5 billion last year. Amvuttra, an injectable medicine, competes with Pfizer's drug and BridgeBio Pharma's Attruby, both of which are taken orally. Attruby reached market earlier and is also off to a faster-than-expected start. Alnylam priced Amvuttra in cardiomyopathy at $476,000 per year, a significant premium to its rivals, despite the fact clinical results didn't appear strong enough to indicate its drug is clearly superior. Alnylam executives have said they expect Amvuttra to grow the market for ATTR cardiomyopathy medicines, as most patients still aren't on treatment. They've also expressed confidence Amvuttra could become a standard option. The drug works differently than its competitors and, because it's only injected four times a year, could have better adherence, they've said. So far, its optimistic projections appear to be playing out. On a conference call Thursday, some analysts questioned whether the better-than-expected numbers were driven by a surge of initial prescriptions for sicker people whose disease had been progressing on other medicines. CEO Yvonne Greenstreet said the company is seeing 'broad uptake' that includes newly diagnosed patients as well. Chief Commercial Officer Tolga Tanguler added many commercial and Medicare insurers already have policies out and are clearing use in newly diagnosed patients, indicating they aren't requiring people take Pfizer or BridgeBio's drugs first. A month into the quarter, Alnylam began to see a 'very healthy and accelerating trend in first-line use,' he said. The results are 'not just a flash in the pan,' Greenstreet added. 'We expect continuous, sustainable growth,' she said. Following the call, Stifel analyst Paul Matteis wrote in a research note the higher guidance still 'looks beatable' and raised his projections for Amvuttra's peak annual sales to $9 billion, up from about $7 billion previously. Alnylam intends to gradually lower Amvuttra's net price through rebates and pay-for-performance deals as patient uptake increases. On Thursday's call, CFO Jeff Poulton said to expect a 'mid-single digit reduction in net price' this year. Recommended Reading BridgeBio sales of new heart drug outstrip expectations Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
01-08-2025
- Business
- Globe and Mail
ALNY Q2 Earnings Top Estimates on Higher Amvuttra Revenues, Stock Up
Alnylam Pharmaceuticals, Inc. ALNY reported second-quarter 2025 earnings of 32 cents per share, in contrast to the Zacks Consensus Estimate of a loss of 3 cents. The improvement was due to higher revenues from the sale of its lead drug, Amvuttra (vutrisiran). The company reported adjusted earnings of 56 cents in the year-ago quarter. Alnylam recorded total revenues of $773.7 million in the quarter, which easily surpassed the Zacks Consensus Estimate of $673 million. In the year-ago quarter, total revenues were $659.8. The top line rose 17% year over year on a reported basis and 16% at a constant exchange rate (CER), mainly driven by increased product sales. Net product revenues were $672.2 million, up 64% year over year on a reported basis and 62% at CER, driven by strong growth in patient demand for Amvuttra, as well as for Givlaari (givosiran) and Oxlumo (lumasiran). ALNY shares jumped 15.4% on Thursday as investors responded positively to the strong financial performance of its marketed drug portfolio. Net revenues from collaborators were $61.5 million, down 73% from the year-ago quarter, primarily due to a $185 million milestone payment received from Regeneron REGN in the year-ago quarter upon granting REGN an exclusive license to develop, manufacture and commercialize cemdisiran as a monotherapy. Furthermore, Alnylam did not recognize any revenues from Novartis NVS in the reported quarter. ALNY recognizes revenues under its ongoing collaborations with Roche RHHBY. Alnylam also recognized royalty revenues of $40 million in the reported quarter, up 78% year over year. ALNY's Q2 Results in Detail Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $52.5 million in the reported quarter, down 32% on a reported basis. Onpattro sales beat the Zacks Consensus Estimate of $45.9 million as well as our model estimate of $46 million. Amvuttra is FDA-approved for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission also approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy. Recently, label expansion for the drug has also been approved in the United States and the EU for treating cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. Amvuttra generated sales worth $492 million in the second quarter, up 114% on a reported basis. The uptake for the product has been encouraging, with new patients starting treatment as well as several patients switching from Onpattro. The expanded label is also boosting sales. Amvuttra sales easily beat the Zacks Consensus Estimate of $365.4 million as well as our model estimate of $330.7 million. Givlaari, approved for the treatment of acute hepatic porphyria, recorded sales of $80.8 million, reflecting a year-over-year increase of 30% on a reported basis. Givlaari sales beat the Zacks Consensus Estimate of $72.6 million and our model estimate of $73.1 million. Oxlumo recorded global net product revenues of $46.9 million in the reported quarter, up 15% year over year on a reported basis. Oxlumo sales marginally beat the Zacks Consensus Estimate of $46.6 million as well as our estimate of $43.5 million. Year to date, ALNY stock has soared 66.7% compared with the industry 's 1.5% rise. Adjusted research and development (R&D) expenses gained 11% year over year to $274.1 million. R&D expenses accounted for costs associated with the startup activities for a phase III cardiovascular outcomes study, which will evaluate zilebesiran to treat patients with hypertension at high cardiovascular risk, in partnership with Roche. Expenses associated with the recently initiated phase III TRITON-CM study, evaluating nucresiran in patients with ATTR-CM, also contributed to higher R&D costs. Adjusted selling, general and administrative (SG&A) expenses increased 26% year over year to $261.2 million, primarily due to higher employee compensation costs and increased marketing investment associated with the Amvuttra launch for ATTR-CM. Cash, cash equivalents and marketable securities as of June 30, 2025, amounted to $2.86 billion compared with $2.63 billion recorded as of March 31, 2025, with the increase primarily driven by net cash inflows from operating activities and proceeds from the exercise of employee stock options. ALNY Updates 2025 Net Sales Guidance Alnylam now expects its net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $2.65-$2.8 billion for 2025, up from the previously guided range of $2.05-$2.25 billion. The guidance for net revenues from collaborations and royalties is maintained in the range of $650-$750 million. Adjusted R&D and SG&A expenses are expected to remain in the band of $2.1-$2.2 billion. ALNY's Ongoing Collaboration Agreements Alnylam, in collaboration with Regeneron, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases. The agreement regarding cemdisiran underwent a modification last year. Per the modified agreement, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as monotherapy and in combination with anti-C5 antibodies for complement-mediated indications. ALNY regained full global development and commercialization rights to mivelsiran in all indications in 2024, after Regeneron opted out of further co-development and co-commercialization of mivelsiran in development for cerebral amyloid angiopathy and Alzheimer's disease. However, Regeneron will be eligible to receive low double-digit royalties on sales of mivelsiran, if approved. Alnylam, in collaboration with Roche, is developing zilebesiran in a mid-stage study (KARDIA-3) to treat hypertension. ALNY and RHHBY also plan to initiate a phase III cardiovascular outcomes study for the candidate by the end of 2025 for the same indication. Alnylam has granted Novartis exclusive global rights to manufacture and commercialize RNAi therapeutics targeting PCSK9, including Leqvio (inclisiran), for hypercholesterolemia and other diseases. The FDA has approved Leqvio for several heart disease indications alongside diet and statins. As of June 2025, Leqvio is approved in more than 106 countries, with ongoing late-stage studies for further label expansion. Our Take Alnylam reported better-than-expected results in the second quarter of 2025, beating earnings and revenue estimates. The year-over-year increase in revenues has been mainly fueled by growing Amvuttra sales as a result of increased patient demand. The recent label expansion of the drug for the ATTR-CM indication in the United States and the EU has further expanded the eligible patient population for the drug, which is boosting sales and is expected to continue to do so in the quarters ahead. Sales of other products, Givlaari and Oxlumo, are also contributing to the top line. ALNY's Zacks Rank Alnylam currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Zacks' Research Chief Names "Stock Most Likely to Double" Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest. This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%. Free: See Our Top Stock And 4 Runners Up Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report Novartis AG (NVS): Free Stock Analysis Report
Yahoo
30-06-2025
- Business
- Yahoo
BMO Capital Maintains ‘Outperform' Rating on Alnylam Pharmaceuticals, Inc. (ALNY); Raises PT
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is among the best stocks added in a . A well-stocked pharmacy shelf full of the company's pharmaceuticals, nutraceuticals, over-the-counter medications, and health care products. BMO Capital maintained an 'Outperform' rating on Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), announcing this on June 24, 2025. The analyst raised its price target on the company's stock from $300 to $360. BMO Capital attributed this update to a drastic increase in Amvuttra sales for ATTR-CM, according to IQVIA tracking data, after the drug's approval in March. Furthermore, the analyst cited the continued consistency of the company's sales trends, reinforcing confidence in its commercial traction. While short-term skepticism exists regarding the company's revenue growth, Alnylam Pharmaceuticals, Inc.'s (NASDAQ:ALNY) consistent historical trend of revenue and pipeline growth supports its potential for continued growth. Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), a biopharmaceutical company, develops and markets RNAi therapeutics for rare and genetic diseases. The company has demonstrated consistent YoY revenue growth, making it part of the growth stock portfolio. While we acknowledge the potential of ALNY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: 10 Best Marketing Stocks to Buy Right Now and 10 Best Cybersecurity Stocks to Invest in Under $20. Disclosure: None.
