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FDA approves new drug to treat protein buildup in the heart
FDA approves new drug to treat protein buildup in the heart

Yahoo

time24-03-2025

  • Health
  • Yahoo

FDA approves new drug to treat protein buildup in the heart

The U.S. Food and Drug Administration has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra (vutrisiran), is made by Alnylam Pharmaceuticals Inc. and is used to treat transthyretin amyloid cardiomyopathy. ATTR-CM is a disease in which harmful proteins build up in the heart, making it harder to pump blood, according to the American Heart Association. In one study, Amvuttra helped lower the risk of death and heart problems by 28% over three years compared to a placebo. The drug is given as a shot every three months. "We hope this could become our flagship franchise. We're going to help thousands more patients," Alnylam CEO Yvonne Greenstreet said in an interview with STAT News. "It's also a transformational moment for the company." But the treatment comes at a steep price. Each dose costs about $119,000, or $476,000 per year. That's more than double the cost of a similar drug from BridgeBio, and more expensive than Pfizer's pills for the same condition. "There are many, many, many undiagnosed patients and substantial unmet need in this space. This market is very large, underdiagnosed, undertreated," said Dr. Mani Foroohar, an analyst with the health care investment company Leerink. Still, the high cost may make it harder for patients -- especially those on Medicare Advantage plans -- to get the drug. Private insurers may prefer cheaper options like pills from Pfizer or BridgeBio. Amvuttra works differently from those drugs. It uses RNA technology to stop the body from making the bad protein, while the other treatments work to stabilize the protein before it causes harm. In trials, BridgeBio's treatment showed a 42% drop in deaths and heart hospital visits over 30 months. Amvuttra's study showed a 28% drop over three years. But the trials were different, so it's hard to compare the results directly. Amvuttra is already approved to treat a nerve-related form of ATTR. With this new approval, Alnylam hopes the drug will reach many more people. More information Learn more about vutrisiran. Copyright © 2025 HealthDay. All rights reserved.

Market Analysis: Monday March 24th, 2025
Market Analysis: Monday March 24th, 2025

Globe and Mail

time24-03-2025

  • Business
  • Globe and Mail

Market Analysis: Monday March 24th, 2025

Global Market Update Canadian Markets Canada's TSX rose on rising oil prices, while concerns around tariffs between Canada and the U.S., eased somewhat, which had been a source of uncertainty for Canadian investors. The trade tensions and the potential for tariffs had been creating volatility, so the easing of these concerns brought some relief to the market. Data out showed that Canadian February factory sales were most likely down approximately 0.2% for the month, while Canadian economists are forecasting a potential recession for Canada. American Markets U.S. stock markets also rose, particularly among tech stocks, which were leading the rally, on news of a breakthrough in artificial intelligence (AI) by Jack Ma's Ant Group.. Reports released on Monday confirmed that it was suggested that the U.S. government's approach to new tariffs might not be as aggressive as initially feared. Trade tensions between the U.S. and other countries, especially China, had been a key source of volatility for global markets. However, if the new tariff measures are more targeted and moderate, it would reduce the economic strain on U.S. businesses, boosting investor confidence. European Markets In Europe, stock markets closed lower, despite data that showed business activity in the euro zone grew at its fastest pace in seven months in March, a sign that the region's economy might be improving. UK stocks also finished lower, even though there were gains in mining stocks, which helped cushion the overall losses. Data released on Monday showed that the UK's PMI hit a 6 month high. Overall market sentiment was weighed down by concerns over the reciprocal levies that could be imposed by the U.S. Corporate Stock News 23andMe Holding Co: Filed for Chapter 11 bankruptcy protection, aiming to sell itself. The company has secured $35 million in financing and intends to continue operating during the sale process. CEO Anne Wojcicki resigned after failed takeover bids. Azek Company Inc: James Hardie Industries announced an $8.75 billion acquisition of Azek, a U.S. decking maker, valuing Azek shares at $56.88 each, a 37.4% premium. Despite the premium, Azek shares fell due to concerns over paying too much amid a weak U.S. housing market. Alnylam Pharmaceuticals: JPMorgan raised the target price to $328 from $280, citing strong growth prospects for Amvuttra in treating TTR amyloidosis. Apple Inc China's Vice Premier He Lifeng reassured foreign CEOs, including Apple, Pfizer, and Mastercard, about China's economic potential. Apple also announced a $99 million clean energy fund in China to expand its clean energy capacity. Bayer: Ordered to pay $2.1 billion in damages after a jury found its Roundup weed killer caused cancer. Boeing Co: Boeing and Airbus are preparing for increased production of next-generation jets. They are researching lighter materials and robotic assembly for future aircraft replacements. Chevron Corp: CEO Michael Wirth received $32.7 million in compensation for 2024, a 23.4% increase from the previous year. Chevron also announced plans to lay off 15-20% of its workforce by 2026 as part of cost-cutting efforts. Coty Inc: Coty sold its 20% stake in Kim Kardashian's SKKN beauty brand to SKIMS, consolidating both businesses. Coty will use the proceeds to reduce debt and invest in its broader brand portfolio. Darden Restaurants: Stephens raised the target price to $178 from $175, based on the company's strong operational execution and guidance for 2025 same-store sales. Dentalcorp Holdings Ltd: CIBC raised its target price for Dentalcorp Holdings to C$13 from C$11.5, citing the company's stable business model and in-line fourth-quarter results. FedEx Corp: Daiwa Capital Markets lowered the target price to $240 from $285, reflecting updated management guidance and a slower start to 2026. Ford Motor Co: The U.S. National Highway Traffic Safety Administration launched a preliminary probe into 1.3 million Ford F-150 trucks over issues of unexpected gear downshifts and rear-wheel lock-up, raising safety concerns. Lennar Corp: Barclays cut the target price to $110 from $121, citing near-term earnings pressure as the company focuses on a cash generation strategy. Meta Platforms Inc: Meta and OpenAI are in talks with Reliance Industries to expand AI offerings in India, including the potential distribution of ChatGPT and reducing subscription fees. Rapid7 Inc: Rapid7 is nearing a settlement with activist investor Jana Partners to boost share prices and possibly explore a sale. Redfin Corp: JPMorgan raised the target price to $12.5 from $7 after Rocket Companies' acquisition offer for Redfin at $12.50 per share. Target Corp & Walmart Inc: Walmart and Target are negotiating with suppliers over proposed price hikes due to rising costs from tariffs, leading to acrimonious discussions on how much to increase prices without alienating consumers. Tesla Inc: Tesla is preparing to launch its Full Self-Driving (FSD) feature in China after receiving regulatory approval. Meanwhile, protests were held in Washington over Elon Musk's workforce reduction plans. United States Steel Corp: Nippon Steel and U.S. Steel are negotiating with the U.S. government on a potential acquisition deal, which could strengthen the U.S. steel industry. Volkswagen:

Alnylam price target raised to $338 from $300 at Scotiabank
Alnylam price target raised to $338 from $300 at Scotiabank

Yahoo

time22-03-2025

  • Business
  • Yahoo

Alnylam price target raised to $338 from $300 at Scotiabank

Scotiabank raised the firm's price target on Alnylam (ALNY) to $338 from $300 and keeps an Outperform rating on the shares. The firm expects Amvuttra, the first transthyretin silencer to enter the market for the treatment of transthyretin amyloid cardiomyopathy, to see impressive uptake among the first-line setting given its unique mechanism of action, the analyst tells investors. The drug's launch, however, will likely not gain momentum until 2H of 2025, the firm adds. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on ALNY: Questions or Comments about the article? Write to editor@ Alnylam price target raised to $330 from $310 at RBC Capital Alnylam Pharma's Strategic Advancements and Market Potential Support Buy Rating Alnylam Pharma's Amvuttra Gains FDA Approval, Positioned as Leading siRNA Treatment for ATTR-CM Alnylam price target raised to $325 from $302 at BofA Alnylam price target raised to $390 from $385 at Canaccord Sign in to access your portfolio

Stock market falls but S&P 500, Dow end week up. FedEx, Nike warn on outlooks
Stock market falls but S&P 500, Dow end week up. FedEx, Nike warn on outlooks

Yahoo

time22-03-2025

  • Business
  • Yahoo

Stock market falls but S&P 500, Dow end week up. FedEx, Nike warn on outlooks

U.S. stocks closed slightly up, with the broad S&P 500 index and blue-chip Dow finishing the week higher, as investors refocus on tariff threats and economic data, Stocks rallied Wednesday afternoon after the Federal Reserve left interest rates unchanged, as expected, but still predicted two more rate cuts this year despite tariffs that could boost inflation. However, the rally ran out of steam and investors scattered to the sidelines, allowing stocks to drift lower and attention to return to President Donald Trump's tariff threats and potential effects on the economy. Stocks traded off their lows after Trump said Friday there will be 'flexibility' on his reciprocal tariff plan planned to take effect on April 2. However, he seemed to rule out exceptions. 'People are coming to me and talking about tariffs, and a lot of people are asking me if they could have exceptions,' Trump told reporters in the Oval Office. 'And once you do that for one, you have to do that for all,' he said. Separately, earnings warnings from corporate giants like Nike and FedEx spooked the market. The S&P 500 rose 0.08%, or 4.67 points, to 5,667.56 and ended the week in the green to halt a losing streak at four weeks. The Dow added 0.08%, or 32.03 points, to 41,985.35 and posted its best week since January. The tech-heavy Nasdaq advanced 0.52%, or 92.43 points, to 17,784.05, but still unable to climb out of the red for the week, making it the index's fifth straight weekly loss and its longest stretch of weekly losses since May 2022. The benchmark 10-year yield edged up to 4.25%. Nike topped analysts' estimates for earnings and revenue in the company's fiscal third-quarter, but sales in the final three months of its year are expected to be much worse than expectations. Shares of the sportswear giant plunged 5.46%, reaching the lowest level since 2020. Micron beat analysts' forecasts in the second quarter and expects to do so again in the third quarter. However, its gross margins were lower than expected, signaling higher costs that could eat into profits. The tech company's stock slid 8.04%. FedEx earnings missed analysts' expectations in the delivery company's fiscal third-quarter. The delivery company also lowered its earnings outlook, citing economic uncertainty. Shares slumped 6.45%. Carnival's fiscal first-quarter results beat analysts' forecasts, but the cruise company's shares slipped 1.16%. Alnylam Pharmaceuticals shares surged 11.75% after the company received Food and Drug Administration approval to sell its drug Amvuttra to more patients with a genetic heart condition. Tesla shares gained 5.27% after chief executive Elon Musk told the company's employees not to sell the stock despite its shares shedding half their value this year. Metaplanet, a Tokyo-listed investment firm that operates as a Bitcoin treasury company, named Eric Trump, second son of President Trump, to its Strategic Board of Advisors. Separately, the U.S. Treasury Department said it removed economic sanctions against Tornado Cash, a so-called cryptocurrency mixing service that U.S. officials allege was used to launder funds stolen by North Korean hackers. Still, bitcoin was last down 0.41% at $83,887.46. This story was updated with new information. Medora Lee is a money, markets, and personal finance reporter at USA TODAY. You can reach her at mjlee@ and subscribe to our free Daily Money newsletter for personal finance tips and business news every Monday through Friday. This article originally appeared on USA TODAY: Stock market drops but S&P 500, Dow end week up. Tariffs back in focus Sign in to access your portfolio

Alnylam challenges Pfizer and BridgeBio with FDA nod for ATTR-CM drug
Alnylam challenges Pfizer and BridgeBio with FDA nod for ATTR-CM drug

Yahoo

time21-03-2025

  • Health
  • Yahoo

Alnylam challenges Pfizer and BridgeBio with FDA nod for ATTR-CM drug

Alnylam Pharmaceutical's has secured US Food and Drug Administration (FDA) approval for Amvuttra (vutrisiran), expanding its use to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and life-threatening heart disease. This milestone makes Amvuttra the first medication in the US approved for both ATTR-CM and hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), positioning Alnylam as a direct competitor to Pfizer and BridgeBio Pharma in the growing ATTR-CM market. In ATTR-CM, transthyretin (TTR) proteins accumulate in the heart, leading to a stiffening of the heart muscle, reduced blood flow, and an increased risk of heart failure. The ATTR-CM market is currently dominated by Pfizer's Vyndaqel/Vyndamax (tafamidis) and BridgeBio's recently approved Attruby (acoramidis). Unlike these medications, which are TTR stabilisers, Amvuttra is an RNA interference (RNAi) therapy that reduces the production of both wild-type and mutant TTR proteins. By decreasing TTR protein expression, the drug aims to prevent the buildup of amyloid deposits in the heart. The FDA's decision was supported by data from the Phase III HELIOS-B trial (NCT04153149), which evaluated Amvuttra's impact on overall survival and cardiovascular events. The study showed a statistically significant reduction in composite of all-cause mortality and recurrent cardiovascular events. In the trial, the monotherapy group demonstrated a 33% reduction in this composite endpoint, while the overall study population showed a 28% reduction. One notable addition is the drug's impact on the need for medical visits, which could provide Amvuttra a commercial advantage. The drug's label states that Amvuttra reduces the likelihood of hospitalisation, death, and urgent visits for heart contrast, Pfizer's Vyndaqel/Vyndamax and BridgeBio's Attruby do not have language specifying a reduction in urgent heart failure visits. In the announcement accompanying the approval, Alnylam's CEO Yvonne Greenstreet said: 'The FDA approval of Amvuttra for ATTR-CM marks a pivotal advancement for patients, providing a new and clinically differentiated treatment option that has been shown to improve outcomes, including cardiovascular mortality, and reduce progression for those living with this devastating disease.' The ATTRv-PN market has seen significant revenue growth in recent years. Amvuttra generated $970m in 2024, as per the company financials. Amvuttra is expected to make $4.4bn in projected sales by 2030, according to GlobalData's Pharma Intelligence Center. In the same year, BridgeBio's Attruby is forecast to pull in $1.97bn, while Pfizer's Vyndaqel/Vyndamax is linked to a similar $1.94bn revenue forecast after its last outstanding exclusivity expires in 2026. GlobalData is the parent company of Pharmaceutical Technology. "Alnylam challenges Pfizer and BridgeBio with FDA nod for ATTR-CM drug" was originally created and published by Pharmaceutical Technology, 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

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