Latest news with #GileadSciences'
The Hindu
2 hours ago
- Health
- The Hindu
US approves Gilead's twice-yearly injection to prevent HIV
The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded - a 99.9 percent prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Price concerns dampen hope Despite the impressive results, optimism may be tempered by the drug's cost -- a list price of $28,218 per year in the United States, Gilead spokeswoman Blair Baumwell told AFP in an email Wednesday. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually. Baumwell said the $28,000-plus per year cost for Lenacapavir as a preventive drug is "in line with" those of existing PrEP products and that the company inspects insurers to cover it. "We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," she said in the email. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
Int'l Business Times
16 hours ago
- Health
- Int'l Business Times
US Approves Gilead's Twice-yearly Injection To Prevent HIV
The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded -- a 99.9 percent prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Despite the impressive results, optimism may be tempered by the drug's expected high cost. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. While Gilead hasn't disclosed a price for Yeztugo, analysts estimate the US launch cost could reach $25,000 per year. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, though that is expected to drop when used as a preventive. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
GMA Network
18 hours ago
- Health
- GMA Network
US FDA approves Gilead's twice-yearly injection to prevent HIV
WASHINGTON - The US Food and Drug Administration (FDA) on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV, a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have struggled to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," said Daniel O'Day, Gilead's chairman and chief executive officer, in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown in clinical trials to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. But optimism may be tempered by the drug's expected eye-watering price tag. While the company has not disclosed specifics, analysts estimate the US launch price could be as high as $25,000 per year. Activists are calling for the price to be slashed to $25 per person annually to help end the HIV pandemic. The approval also comes as President Donald Trump's administration has slashed funding for HIV treatment and prevention programs both overseas and within the United States. — Agence France-Presse
Yahoo
21-04-2025
- Business
- Yahoo
Gilead Sciences (NasdaqGS:GILD) Reveals Promising Phase 3 Trial Results For Trodelvy In mTNBC
Gilead Sciences recently announced positive results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, highlighting significant benefits in treating metastatic triple-negative breast cancer. This development may have supported the company's 12% price gain in the last quarter, complementing broader oncology advances. Despite a turbulent broader market impacted by global trade tension and inflationary pressures, Gilead's progress in clinical research, financial performance, and strategic announcements such as its collaboration with IDEAYA Biosciences might have countered market dips, aligning its trajectory with prevailing sector trends focused on innovation in healthcare. We've identified 4 risks with Gilead Sciences and understanding the impact should be part of your investment process. Uncover the next big thing with financially sound penny stocks that balance risk and reward. The recent announcement of positive results from Gilead Sciences' Phase 3 ASCENT-04/KEYNOTE-D19 study in metastatic triple-negative breast cancer could potentially enhance their oncology revenue projections. This aligns well with recent efforts to expand in oncology and other therapeutic areas. Gilead's shares have gained 87.56% over the past three years, indicating robust shareholder returns during this period. This compares to a return of 5.9% for the broader US market over the past year. The news about the oncology study might influence revenue and earnings forecasts positively as it strengthens Gilead's treatment offerings, expected to impact long-term revenue growth. Given the clinical success and promising pipeline, there may be upward pressure on analyst price targets. Currently, the share price remains below the consensus price target of US$112.74, suggesting some market optimism about future performance. However, the positive news might not immediately close the gap to the more bullish targets, emphasizing the importance of ongoing monitoring of the company's progress in addressing unmet medical needs. Assess Gilead Sciences' previous results with our detailed historical performance reports. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:GILD. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
21-02-2025
- Business
- Yahoo
Some Investors May Be Willing To Look Past Gilead Sciences' (NASDAQ:GILD) Soft Earnings
Gilead Sciences, Inc.'s (NASDAQ:GILD) recent soft profit numbers didn't appear to worry shareholders, as the stock price showed strength. We think that investors might be looking at some positive factors beyond the earnings numbers. See our latest analysis for Gilead Sciences In high finance, the key ratio used to measure how well a company converts reported profits into free cash flow (FCF) is the accrual ratio (from cashflow). The accrual ratio subtracts the FCF from the profit for a given period, and divides the result by the average operating assets of the company over that time. You could think of the accrual ratio from cashflow as the 'non-FCF profit ratio'. As a result, a negative accrual ratio is a positive for the company, and a positive accrual ratio is a negative. While having an accrual ratio above zero is of little concern, we do think it's worth noting when a company has a relatively high accrual ratio. Notably, there is some academic evidence that suggests that a high accrual ratio is a bad sign for near-term profits, generally speaking. Gilead Sciences has an accrual ratio of -0.26 for the year to December 2024. That indicates that its free cash flow quite significantly exceeded its statutory profit. Indeed, in the last twelve months it reported free cash flow of US$10b, well over the US$480.0m it reported in profit. Gilead Sciences' free cash flow improved over the last year, which is generally good to see. Having said that, there is more to the story. We can see that unusual items have impacted its statutory profit, and therefore the accrual ratio. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. Gilead Sciences' profit was reduced by unusual items worth US$9.5b in the last twelve months, and this helped it produce high cash conversion, as reflected by its unusual items. This is what you'd expect to see where a company has a non-cash charge reducing paper profits. While deductions due to unusual items are disappointing in the first instance, there is a silver lining. When we analysed the vast majority of listed companies worldwide, we found that significant unusual items are often not repeated. And that's hardly a surprise given these line items are considered unusual. In the twelve months to December 2024, Gilead Sciences had a big unusual items expense. All else being equal, this would likely have the effect of making the statutory profit look worse than its underlying earnings power. Considering both Gilead Sciences' accrual ratio and its unusual items, we think its statutory earnings are unlikely to exaggerate the company's underlying earnings power. After considering all this, we reckon Gilead Sciences' statutory profit probably understates its earnings potential! So while earnings quality is important, it's equally important to consider the risks facing Gilead Sciences at this point in time. You'd be interested to know, that we found 5 warning signs for Gilead Sciences and you'll want to know about them. Our examination of Gilead Sciences has focussed on certain factors that can make its earnings look better than they are. And it has passed with flying colours. But there is always more to discover if you are capable of focussing your mind on minutiae. For example, many people consider a high return on equity as an indication of favorable business economics, while others like to 'follow the money' and search out stocks that insiders are buying. So you may wish to see this free collection of companies boasting high return on equity, or this list of stocks with high insider ownership. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
