Latest news with #Yeztugo
Reuters
6 days ago
- Health
- Reuters
EU regulator backs Gilead's twice-yearly injection for HIV prevention
July 25 (Reuters) - The European Union's drugs regulator has recommended approval of Gilead Sciences' (GILD.O), opens new tab lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents, the drugmaker said on Friday. The backing could make it the EU's first twice-yearly HIV prevention option to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents. Lenacapavir offers a long-acting alternative to daily oral pills and other shorter-acting options, aiding critical response to the disease especially among those who struggle with daily adherence, stigma, or access to healthcare. The decision comes more than a month after the treatment received regulatory approval in the U.S., where it is branded as Yeztugo. The World Health Organization recommended the treatment earlier this month as a tool to prevent HIV infection. Any recommendation by the European Medicines Agency's human medicines committee has to be formally approved by the European Commission, which usually follows the regulator's decision. The European Commission's decision on the drug is expected later this year, the company said. If approved,lenacapavir would be granted one additional year of market exclusivity in the EU, and it would be branded as Yeytuo, Gilead said. Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year.
The Hill
21-07-2025
- Health
- The Hill
We can't win the fight to end HIV if we cut funding and access to medication
The fight to end HIV in our lifetimes just received a game-changing innovation. In June, the FDA approved Yeztugo (lenacapavir), a groundbreaking HIV prevention treatment that requires just two injections per year — and scored 99 percent effectiveness in trials. This monumental scientific breakthrough is poised to transform the lives of people who have found it hard to keep up with daily oral pre-exposure prophylaxis, providing an option that fits better into their everyday lives. But as exciting as this development is, it could be undermined by the Trump administration's proposal to cut nearly $1 billion from federal HIV prevention programs. Innovations like lenacapavir could be a key tool to ending the epidemic, but only if we have the resources and policy to deliver it directly to those who need them most. Although lenacapavir's efficacy is groundbreaking, access remains another story. With a price tag hovering around $28,000 a year, this medication risks being out of reach for the very communities who need it most. We're still waiting to see how programs managed by Gilead Sciences, which developed the treatments, and the broader insurance markets will step up. And it's not just the cost of the drug itself. It's the labs, the provider visits, the follow-ups — each one a potential roadblock for someone trying to stay safe. Federal leadership is essential to ensuring this new HIV prevention tool reaches the communities who need it most. This includes updating clinical guidelines, funding support services and supporting the infrastructure that makes access possible. Unfortunately, the Trump administration and the Republican majorities in Congress are putting access to lifesaving innovations at risk. The administration's attacks on HIV prevention, including its proposals to eliminate the Centers for Disease Control and Prevention's HIV budget and efforts to dismantle public health systems, threaten progress. The Republican budget reconciliation bill that President Trump signed over the July 4 weekend includes deep cuts to Medicaid — the largest payer for HIV care in the U.S. Without strong federal investment and coordination, expanding access to new tools and ending the HIV epidemic is at serious risk. Despite the real strides we have made in HIV prevention, those of us in the lesbian, gay, and transgender community — especially non-white Southerners in rural areas or navigating poverty — know that not every prevention strategy reaches us, works for us, or is built with us in mind. Our realities demand options that reflect the full truth of who we are and how we live. Lenacapavir offers real, powerful hope, but let's be clear: Science alone won't save us. What will make the difference is equitable and intentional policies that center our communities and a public health infrastructure that doesn't leave us behind. These numbers don't shift on their own. Yes, we have made progress over time. But the hard truth is that Black Americans still account for 43 percent of all new HIV diagnoses in the U.S., despite being just 13 percent of the population. The data is even more stark for Black transgender women: 44 percent are living with HIV, and their lifetime risk remains unacceptably high. And we cannot ignore the geography of this epidemic. The South accounts for 52 percent of all new HIV diagnoses in the U.S. That's not a coincidence — it is the result of systemic failures: limited access to healthcare, persistent stigma, lack of comprehensive sex education and the absence of strong non-discrimination protections. These barriers don't just prevent care — they trap people in cycles where prevention tools are out of reach. Among gay and bisexual Black men, the risk of contracting HIV is still 50 percent over a lifetime. Prevention tools like pre-exposure prophylaxis and lenacapavir hold promise, but they only matter if people can actually access them, without fear, shame or coercion. Ending this epidemic means creating environments where people are safe to make informed choices about their own health. The fight to end the HIV epidemic is not just about what happens in labs — it's about how we make these innovations real for our communities. Science is doing its part. Now is the time to urge Congress to reject any cuts to CDC HIV prevention efforts and to fully fund the HIV response. We have the tools to end this epidemic, but not if we dismantle the very systems our communities rely on to survive. The promise of lenacapavir, and the hope it represents, is too great to let fall through the cracks of policy neglect. The question is, will we make the choice to ensure that this breakthrough reaches all of us? Science has given us the tools. Now, we must ensure that everyone has the opportunity to use them.
Yahoo
15-07-2025
- Health
- Yahoo
ViiV's HIV shot preferred, as activists spotlight funding crisis at IAS 2025
ViiV Healthcare's combination injectable human immunodeficiency virus (HIV) medication was preferred over a daily tablet in treatment-naïve patients in a Phase IIIb trial. A global specialist in HIV that is majority owned by GSK, with Pfizer and Shionogi as shareholders, ViiV announced data from the Phase IIIb VOLITION study (NCT05917509) at the International AIDS Society (IAS) conference 2025, taking place from 13 to 15 July in Kigali, Rwanda. In the study, 89% of treatment-naïve HIV patients switched to Cabenuva (a combination treatment of cabotegravir and rilpivirine) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine). Cabenuva is dosed once every two months by a healthcare professional. Patients were initially treated with daily Dovato until they achieved viral suppression. At this point, they were offered the opportunity to change to Cabenuva. The most common reasons cited for choosing Cabenuva were not having to worry about missing a dose each day (80%) and not having to carry medication (68%). ViiV CMO Jean van Wyk said: 'Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.' Patients were initially treated with daily Dovato until they achieved viral suppression. At this point, they were offered the opportunity to change to Cabenuva. Effectiveness was also sustained with Cabenuva in the real world, with data from several observational studies. In these studies, Cabenuva was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control. It also provides better adherence to treatment, something which is a real issue with daily PrEP options due to stigma concerns. GlobalData, the parent company of Clinical Trials Arena, predicts sales of Cabenuva to reach $2.83bn in 2030. ViiV is also investigating an HIV therapy that can be dosed once every four months. In a Phase IIb trial, the therapy was able to suppress viral load below 50 copies per millimetre in blood. Long-acting pre-exposure prophylaxis (PrEP) for HIV has been prominent on the agenda at the IAS 2025 meeting. MSD has initiated two Phase III studies of its monthly oral PrEP candidate, and Gilead is set to report more positive data from its two-Phase III studies of twice-yearly Yeztugo (lenacapavir). On 14 July, the World Health Organization (WHO) endorsed the use of Yeztugo, saying that without a vaccine, it is the 'next best thing'. GlobalData analysts highlighted that the approval of Yeztugo is a 'momentous step in improving PrEP options available for people vulnerable to contracting HIV'. The main topic of conversation at the IAS 2025 conference, however, is the loss of various funding schemes which helped to provide treatment and research into HIV. Funding cuts by Trump's administration are already impacting low-income and middle-income countries, with cases of HIV already rising just six months after the reductions were made. During IAS's opening session, a group of activists took to the stage to vocalise their anger at the loss of funding, as well as some companies removing their diversity policies that recognised patients from LGBTQ+ communities, many of whom are more susceptible to transmitting HIV. The activists chanted 'we will not be erased' as they took to the stage, with several members of the group sharing their views and experiences as HIV patients from the LGBTQ+ community. The conference states it is welcoming of protests and that it 'endorses freedom of speech as an essential principle to end the HIV pandemic as a threat to public health'. "ViiV's HIV shot preferred, as activists spotlight funding crisis at IAS 2025" 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.
Yahoo
15-07-2025
- Business
- Yahoo
Bernstein Maintains Buy Rating on Gilead Sciences (GILD) Stock
Gilead Sciences, Inc. (NASDAQ:GILD) is one of the Best Large Cap Value Stocks to Invest In. Analyst Courtney Breen of Bernstein maintained a 'Buy' rating on the company's stock, retaining a price objective of $120.00. The analyst's rating is backed by a combination of factors associated with the promising prospects of the new drug, Yeztugo. The drug, which is also known as Lenacapavir, was recently approved by the FDA for use as a monotherapy in preventing HIV, which can significantly drive Gilead Sciences, Inc. (NASDAQ:GILD)'s growth, added the firm's analyst. A physician and a patient having a discussion in a hospital about biopharmaceutical medicines. Furthermore, the innovation in Yeztugo's dosing paradigm is expected to enhance patient adherence as well as expand the PrEP market. Despite the concerns related to the drug's pricing, the analyst believes that the perceived financial burden might be mitigated by the insurance coverage. The analyst has also highlighted Gilead Sciences, Inc. (NASDAQ:GILD)'s strategic efforts to address logistical challenges. Overall, such factors, together with the drug's clinical differentiation and market receptivity, support the analyst's favourable outlook for the company's stock. Notably, the company has announced a strategic partnership agreement with the Global Fund to fight AIDS, Tuberculosis, and Malaria to supply lenacapavir, Gilead Sciences, Inc. (NASDAQ:GILD)'s twice-yearly injectable HIV-1 capsid inhibitor, for preventing HIV as pre-exposure prophylaxis (PrEP). Impax Asset Management, an investment management company, released its Q1 2025 investor letter. Here is what the fund said: 'Gilead Sciences, Inc. (NASDAQ:GILD) (Health Care) the company is owned due to its role in solving evolving heath care challenges through the development of new medical treatments for conditions as chronic diseases are on the rise. The company also has one of the highest systematic ESG scores in the portfolio. Gilead reported better-than-expected quarterly results, largely driven by strong revenue from its HIV franchise. The company also provided an optimistic earnings guidance for the next fiscal year, helping provide defensiveness amid a flurry of volatility.' While we acknowledge the potential of GILD 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 best short-term AI stock. READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now Disclosure: None. This article is originally published at Insider Monkey. 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
Yahoo
15-07-2025
- Business
- Yahoo
Gilead Sciences (GILD) Reaches Deal to Offer HIV Vaccine to Low and Middle-Income Nations
Gilead Sciences, Inc. (NASDAQ:GILD) is one of Goldman Sachs' top healthcare stock picks. On July 10, the company announced it had reached an agreement with the Global Fund to Fight Aids, Tuberculosis, and Malaria. Under the agreement, the company is to make available its twice-a-year HIV pre-exposure prophylactic Yeztugo accessible to low- and middle-income countries. kurhan / It marks the first time that preventive HIV medicine will become available to low and middle-income countries, as is the case in high-income countries. As Gilead makes the drug available, the nonprofit is to select beneficiary countries based on HIV programs available in the places. The FDA approved Gilead's Yeztugo, a twice-yearly injection, last month. The approval is seen as a significant win for the company, with analysts insisting it has the potential to redefine the PrEP market. The drug is currently priced at $28,218 for a year's worth of shots, and waiting to see if the company will offer the nonprofit organization a profit. Gilead Sciences, Inc. (NASDAQ:GILD) is a biopharmaceutical company that discovers, develops, and commercializes medicines in the areas of unmet medical need. It develops medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. While we acknowledge the potential of GILD 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 best short-term AI stock. READ NEXT: 11 Best Green Energy Penny Stocks to Buy Right Now and 10 Most Popular AI Penny Stocks to Buy According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. 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
