Latest news with #Sunlenca
Yahoo
2 days ago
- Health
- Yahoo
US FDA pauses Gilead trials testing experimental HIV pill combination
By Sneha S K (Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in some patients, the company said on Tuesday. Shares of the company, a global leader in HIV drugs, were down 2.3% at $110.35. The agency placed the trials on hold after some patients who received the combination of the drugs, GS-1720 and GS-4182, were found to have low levels of a type of white blood cell called CD4+T-cell, the company said. Gilead did not provide more information on what caused the decline in the type of white blood cell, which is a key measurement in HIV management and serves as a guide for treatment. The company said it plans to investigate and will work with regulatory authorities to resolve the issues. The paused trials included two mid-to-late studies, and three more in the early phase, the company said. The mid-to-late stage trials were testing the oral combination treatment against Biktarvy, Gilead's once-a-day pill to treat HIV. "Today's update underscores the difficulties of improving upon the profile of Gilead's once-daily Biktarvy," said BMO Capital Markets analyst Evan Seigerman. GS-4182 is an experimental pill version of the company's approved HIV drug lenacapavir, while GS-1720 is a once-weekly therapy in development for treatment of HIV. The company said the hold is not related to Gilead's application seeking FDA's approval for lenacapavir in preventing HIV. The agency is set to decide on the application by June 19. The FDA had approved lenacapavir for HIV treatment in 2022 and is sold under the brand Sunlenca. Gilead has multiple other long-acting oral and injectable HIV treatment combinations under development, and this clinical hold does not impact those combinations, the drugmaker said.
Forbes
01-05-2025
- Health
- Forbes
Why A Single Drug Could Change Everything For HIV And AIDS
CHENGDU, CHINA - DECEMBER 1: (CHINA OUT) A migrant worker wears a red ribbon during an event ... More organized by the local government to promote HIV/AIDS knowledge among migrant workers . (Photo by) A twice-yearly injection of a drug known as Sunlenca offered 100% protection against HIV among young women and girls in South Africa and Uganda, according to research published in the New England Journal of Medicine. Over 5,000 girls participated in the study, with participants receiving either the twice-yearly shot or an oral pill for HIV prevention. Of those receiving the oral pill, 2% eventually acquired HIV from infected sex partners. The study did not examine what the effect of Sunlenca would be on men. The twice-yearly shot is manufactured by U.S. drug maker Gilead and is sold as Sunlenca (Lenacapavir), but only to treat HIV, not prevent it. If found to prevent HIV infection with 100% efficacy in men too, the drug could be a huge game-changer for HIV and AIDS. Here is why. The drug operates differently from most HIV medications that usually target enzymes. Sunlenca, on the other hand, targets the HIV capsid which is a protein shell that encases the virus's genetic material. This allows the drug to interfere with multiple stages of the HIV life cycle, including but not limited to the virus's ability to assemble new viral particles, replicate and enter cells. This unique mechanism of action plays a huge role in its success to prevent the HIV virus from proliferating in a person's body. The drug is also long-acting and is injected as opposed to taken orally. This has many advantages, since taking daily oral pills can be difficult for most patients. In one study, the median rate of compliance in taking an oral pill for HIV pre-exposure prophylaxis among men was just about 64%, highlighting a major barrier in HIV prevention. Many patients on drugs for any reason struggle with the burden of taking daily pills, leading to missed doses and suboptimal treatment for their specific disease. Sunlenca's twice-yearly dose regimen eases compliance to treatment and could potentially lead to very low if not zero rates of HIV infection in the future if it were ever recommended for prevention. Sunlenca also has the potential to mitigate the stigma and psychological toll of patients that have or may be at high risk of getting HIV. Taking daily oral pills to treat or prevent HIV can act as a constant reminder of HIV for an individual, a viral infection acquired primarily through sexual contact or sharing of needles. HIV stigma refers to the negative beliefs and attitudes regarding people with HIV, which include but are not limited to judging people who are taking steps to prevent HIV or treating them differently. A twice-yearly injection can reduce this stigma, allowing people to live more normal lives without the constant reminder of their HIV status. Finally, Sunlenca can have broader implications for public health. Globally, there are approximately 40 million people living with HIV, according to Kaiser Family Foundation. Imagine a world where people can take an injection once every six months, and not worry about ever contracting the virus. This could be a reality if Sunlenca is shown to prevent HIV in a broader population, as it already has shown to be 100% effective among young girls in South Africa and Uganda. Although more thorough research and testing will be needed, Sunlenca could be a game-changer for HIV prevention. It offers a much needed hope for the millions around the world who could potentially prevent getting HIV altogether.
Yahoo
24-04-2025
- Business
- Yahoo
Top 20 biopharmas' market cap rises 6% in Q1 2025 amid tariff headwinds
The top 20 biopharmaceutical companies demonstrated a strong start to 2025, despite ongoing uncertainty surrounding the potential impact of President Trump's proposed pharmaceutical tariffs on global supply chains. Nevertheless, these companies reported an upturn of 6% in aggregate market capitalisation from $3.7tn on 31 December 2024 to $3.9tn on 31 March 2025, reveals GlobalData, a leading data and analytics company. Vertex Pharmaceuticals recorded the highest market capitalisation growth in Q1 2025, rising 22% to $127bn, driven by strong demand and continued expansion of its cystic fibrosis portfolio. Vertex recently received FDA approval for Alyftrek (deutivacaftor + tezacaftor + vanzacaftor calcium) in December 2024, followed by UK MHRA approval in March 2025. Alyftrek adds a next-in-class, once-daily triple combination therapy to Vertex's existing cystic fibrosis offerings. In addition to strengthening its cystic fibrosis portfolio, Vertex is also diversifying its pipeline. The FDA's January 2025 approval of Journavx (suzetrigine), a non-opioid oral pain treatment, further contributed to the company's market capitalisation growth. Gilead Sciences witnessed a market capitalisation growth of 21.1%, fueled by promising developments in its HIV portfolio. This includes successful Phase I data for a once-yearly formulation of Sunlenca (lenacapavir) for HIV prevention, building on the successful Phase III PURPOSE 1 and 2 trials of its twice-yearly formulation. The candidate is under FDA priority review, with approval anticipated by mid-2025. Further strengthening its HIV pipeline, Gilead also reported positive Phase III results from the ALLIANCE trial, which evaluated Biktarvy (bictegravir sodium + emtricitabine + tenofovir alafenamide) for patients with both HIV and hepatitis B co-infection. Roche reported an 18.5% increase in market capitalisation due to its $5.3bn licensing agreement with Zealand Pharma (in March 2025) to co-develop and co-commercialise petrelintide and a fixed-dose combination with Roche's asset, CT-388, marking its expansion into the cardiovascular, renal, and metabolic space. Amgen saw a 17.7% market capitalisation growth, attributed to robust product sales, with double-digit growth across ten key products. Notable contributors included Repatha (evolocumab) for hypercholesterolemia and hyperlipidemia, Blincyto (blinatumomab) for B-cell acute lymphocytic leukaemia, recently approved in June 2024, and Tezspire (tezepelumab-ekko) for severe asthma. Amgen's market capitalisation growth was further fueled by recent positive Phase III data for Tezspire in the WAYPOINT trial in March 2025 for chronic rhinosinusitis with nasal polyps, and Uplizna (inebilizumab), which is now the first and only FDA-approved treatment for immunoglobulin G4-related disease. Novo Nordisk experienced a 21.1% decline in market capitalisation, despite its weight loss drug Wegovy (semaglutide) generating $2.8bn in Q4 2024—more than double the sales from the same period in 2023, according to GlobalData's Drugs Database Pharma Intelligence Center. However, sluggish sales momentum for both Wegovy and Ozempic, combined with investor concerns over growing competition from Lilly's Zepbound, which showed superior weight loss results in head-to-head trials (20.2% versus Wegovy's 13.7%), has raised doubts about Novo Nordisk's market leadership in the weight loss market. Daiichi Sankyo's market capitalisation fell 14.1% over Q1 2025, following disappointing late-stage results from the Phase III TROPION-Lung01 trial. The company's investigational antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), failed to show an overall survival benefit in second-line non-small cell lung cancer, leading to the withdrawal of its regulatory application. However, Dato-DXd has since secured its first approval for the treatment of unresectable or metastatic HR-positive, HER2-negative breast cancer. Regeneron Pharmaceuticals registered an 11% market capitalisation decline due to involvement in a lawsuit that alleges misleading pricing practices for its highly successful drug, Eylea (aflibercept), for eye diseases. Meanwhile, the 10.4% market capitalisation fall of Merck & Co (MSD) was largely due to ongoing investigations and allegations of misleading safety claims related to its HPV vaccine, Gardasil (human papillomavirus [serotypes 6, 11, 16, 18] [virus-like particle, quadrivalent] vaccine). Nonetheless, Merck successfully dismissed the plaintiffs' claims, and Gardasil remains its second-best-selling drug, with $8.58bn in sales in 2024, according to GlobalData's Drugs Database Pharma Intelligence Center. The biopharmaceutical industry is positioned for continued recovery, driven by recent FDA approvals and billion-dollar strategic collaborations. However, uncertainty remains as the implications of Trump's proposed pharmaceutical tariffs unfold, raising concerns over the likelihood of additional interest rate cuts as the possibility of higher tariffs is on the horizon. As a result, industry leaders will continue to remain cautious during these shifting economic conditions. For further insights into the latest Deal Trends in the Pharma Sector, please see our Venture Capital Investment Trends in Pharma - Q1 2025 and M&A Trends in Pharma - Q1 2025 reports. Navigate the shifting tariff landscape with real-time data and market-leading analysis. Request a free demo for GlobalData's Strategic Intelligence . "Top 20 biopharmas' market cap rises 6% in Q1 2025 amid tariff headwinds" 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
Yahoo
27-03-2025
- Health
- Yahoo
UNAIDS chief urges Donald Trump to make an 'amazing deal' to end HIV
UNAIDS chief Winnie Byanyima said the sudden loss of American money has been "devastating" for efforts to stop HIV and will cost many lives of the world's most vulnerable people. But she also proposed an "amazing deal" for US President Donald Trump that she said could result in "the end of AIDS". At a news briefing in Geneva, Byanyima said that the deal would involve Trump enabling the US company Gilead to produce and licence its "magical" prevention drug lenacapavir across the world to the millions of people who need it. Related Trump's pause on foreign aid raises HIV risks for millions, World Health Organization warns Lenacapavir, sold as Sunlenca, has been shown through twice-yearly injections to completely prevent HIV infection in women and works nearly as well in men. "President Trump likes deals," Byanyima said, acknowledging that it was President George W Bush who first started paying for the widespread roll-out of HIV drugs more than two decades ago. "It could be President Trump, another Republican president, who leads the prevention revolution towards the end of AIDS," the UNAIDS director said. She added that the deal would result not only in profits for Gilead and create jobs for Americans, but save millions of lives in poorer countries. Byanyima said that American money made up about 35 per cent of UNAIDS' core budget last year, but it was unclear whether that might be restored for next year. Related US funding freeze could mean HIV treatment delays for thousands in Ukraine She said the agency was in talks with the US government but was also preparing for a worst-case scenario, in which there was no funding available from the US. Byanyima said it was unlikely any other donors would be able to fill that vacuum, adding that European donors have told the agency they would be cutting back on their support in order to redirect their funds to defence and other priorities. Byanyima said that unless support for HIV efforts is restored, there could be more than 6.3 million additional deaths in the next four years and an additional 2,000 people per day becoming infected. Related Number of Europeans diagnosed with HIV rose in 2023 with new cases in most countries She acknowledged that there has been some valid criticism regarding how HIV aid has been delivered, calling it "an opportunity to rethink and develop more efficient ways of delivering life-saving support". Byanyima also said African countries were trying to become more self-sufficient and that even some of the poorest nations were now "trying to stretch very weak, fragile health systems to absorb people living with HIV".
Los Angeles Times
24-03-2025
- Health
- Los Angeles Times
UNAIDS director proposes that President Trump make an ‘amazing deal' to end HIV
GENEVA — The head of the United Nations' AIDS agency said Monday that the sudden loss of American money has been 'devastating' for efforts to stop HIV and will cost many lives of the world's most vulnerable people. But she also proposed an 'amazing deal' for President Trump that she said could result in 'the end of AIDS.' At a news briefing in Geneva, UNAIDS Executive Director Winnie Byanyima said that the deal would involve Trump enabling the U.S. company Gilead to produce and license its 'magical' prevention drug lenacapavir across the world to the millions of people who need it. Lenacapavir, sold as Sunlenca, has been shown through twice-yearly injections to completely prevent HIV infection in women and works nearly as well in men. 'President Trump likes deals,' Byanyima said, acknowledging that it was President George W. Bush who first started paying for the widespread rollout of HIV drugs more than two decades ago. 'It could be President Trump, another Republican president, who leads the prevention revolution towards the end of AIDS,' Byanyima said. She added that the deal would result not only in profits for Gilead and create jobs for Americans, but save millions of lives in poorer countries. Byanyima said that American money made up about 35% of UNAIDS' core budget last year, but it was unclear whether that might be restored for next year. She said the agency was in talks with the U.S. government, but was also preparing for a worst-case scenario, in which there was no funding available from the United States. Byanyima said it was unlikely any other donors would be able to fill that vacuum, adding that European donors have told the agency they would be cutting back on their support in order to redirect their funds to defense and other priorities. Byanyima said that unless support to HIV efforts is restored, there could be more than 6.3 million additional deaths in the next four years and an additional 2,000 people per day becoming infected. She acknowledged that there has been some valid criticism regarding how HIV aid has been delivered, calling it 'an opportunity to rethink and develop more efficient ways of delivering life-saving support.' Byanyima also said African countries were trying to become more self-sufficient and that even some of the poorest nations were now 'trying to stretch very weak, fragile health systems to absorb people living with HIV.'
