FDA Approves Gilead's Twice-Yearly Shot for HIV Prevention
Gilead Sciences, Inc. GILD obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV.
The regulatory body approved lenacapavir, under the brand name Yeztugo, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.
This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.
The FDA nod, granted under Priority Review, was based on extraordinary data from the late-stage studies, PURPOSE 1 and PURPOSE 2, which showed that ≥99.9% of participants who received Yeztugo remained HIV-negative.
Year to date, shares of GILD have gained 18.6% against the industry 's decline of 4%.
More on GILD's Yeztugo
The approval of Yeztugo for HIV prevention is a major breakthrough in the fight against HIV epidemic.
At present, there are two FDA-approved daily oral medications for PrEP — Truvada and Descovy. Both of these are marketed by GILD alone.
Please note that Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex.
Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP.
Data from PURPOSE 1 study showed that twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada in cisgender women in sub-Saharan Africa.
Data from the PURPOSE 2 study showed that 99.9% of participants in the Yeztugo group did not acquire HIV infection. Yeztugo was also superiority in preventing of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified.
Yeztugo was also granted Breakthrough Therapy Designation in October 2024.
The European Medicines Agency has also validated the Marketing Authorization Application for twice-yearly lenacapavir for HIV prevention.
Yeztugo Approval – A Significant Boost for GILD
As the first long-acting injectable PrEP administered just twice a year, Yeztugo addresses persistent barriers that have limited broader PrEP adoption, such as challenges with daily oral PrEP, adherence, stigma and healthcare access.
This approval represents a paradigm shift in HIV prevention and is expected to catalyze uptake among populations that have historically been underserved by existing prevention tools. Yeztugo has a competitive advantage as it needs to be taken only twice yearly, unlike daily oral pills, and addresses a broad population.
Gilead has a market-leading portfolio of HIV treatments. Flagship drug Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum.
The approval of Yeztugon solidifies its HIV portfolio as its other prevention drug, Truvada, faces generic competition.
We note that lenacapavir is already approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. It is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, who are at risk of HIV acquisition.
A long-acting injectable form of PrEP was also approved by the FDA. In 2021, the regulatory body approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV.
ViiV Healthcare is a global specialist HIV company, majorly owned by GSK plc GSK, with Pfizer and Shionogi as shareholders. The company was formed by GSK and Pfizer in 2009.
Apretude is given first as two initiation injections, administered a month apart and then every two months. Patients in need can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to understand how well they can tolerate the drug.
Approval of better HIV treatments should strengthen GILD's HIV franchise in the wake of increasing competition from the likes of GSK.
GSK's HIV portfolio sales are being driven by strong patient demand for Cabenuva, Apretude and Dovato. The company is also focused on the development of the next generation of HIV innovation with integrase inhibitors (INSTIs) for HIV treatment and prevention.
GILD's Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.53 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 23 cents to $9.02 during this timeframe. The stock has risen 22% so far this year.
BAYRY's 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 59.8%.
BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
Only $1 to See All Zacks' Buys and Sells
We're not kidding.
Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.
Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators, and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.
See Stocks Now >>
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
GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report
Novartis AG (NVS): Free Stock Analysis Report
Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CTV News
an hour ago
- CTV News
Montreal teen tops global chemistry competition
Rama Jamal Alhashemi placed first in the world at the international Avogadro Chemistry Competition. Solutions and gases are no match for 17-year-old Rama Jamal Alhashemi, who placed first in the world in the international Avogadro Chemistry Competition. 'Today we're going to be doing a neutralization reaction with 0.1 molar of NaOH sodium hydroxide and one molar of hydrochloric acid, which is HCL.,' she explained. From the moment she set foot in the laboratory, the recent high school graduate was enamoured with periodic elements. She also took a liking to titration experiments - the process of determining the concentration of solutions. 'To know when our titration is over, we're going to put in some indicator phenolphthalein. So this indicator will make the solution turn pink,' Alhashemi said while demonstrating. Last month, her skills were put to the test in the international Avogadro Chemistry Competition. The exam consists of 40 multiple-choice questions on the structure of matter and chemical reactions. 'It's put on by the University of Waterloo and in the past 37 years, there's been about 174,000 students across the world who have written the competition,' said Sarah Howard, a senior school science teacher at The Study. Only '0.2 per cent of those people have achieved what Rama achieved,' Howard added. Alhashemi placed first in Quebec, first in Canada, first in North America and first in the world. Her ranking earned her a certificate of distinction and an elemental tile for outstanding achievement. 'It's an amazing shock,' Alhashemi said. It's a reminder that 'females can be strong in STEM topics and it's something that we should be encouraging more,' Howard told CTV. According to Statistics Canada, women make up less than 30 per cent of those employed in a STEM field. However, as the soon-to-be CEGEP student gears up for Honours Health Science studies at Marianopolis College, she also plans to explore other interests. 'I've been playing the alto saxophone [...] ever since grade six. So I want to continue not only the sciences in the future but keep music on the side as well.'
Globe and Mail
an hour ago
- Globe and Mail
Obesity Clinical Trials Appears Robust With 80+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, ' Obesity Pipeline Insigh t 2025 ' report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Obesity pipeline landscape. It covers the Obesity pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Obesity therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Obesity pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive Obesity Pipeline Report to explore emerging therapies, key Obesity Companies, and future Obesity treatment landscapes @ Obesity Pipeline Outlook Report Key Takeaways from the Obesity Pipeline Report In June 2025, Carmot Therapeutics Inc. announced a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus. In June 2025, Zomagen Biosciences Ltd. conducted a study to understand if taking VTX3232 alone or in combination with semaglutide is safe in participants diagnosed with Obesity. Approximately 160 patients will take VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide. In June 2025, Boehringer Ingelheim organized a study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesity disease to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. In June 2025, Novo Nordisk A/S announced a study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. In June 2025, Hanmi Pharmaceutical Company Limited conducted a phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus. DelveInsight's Obesity pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Obesity treatment. The leading Obesity Companies such as Zealand Pharma, Sciwind Biosciences, Genexine, Sirnaomics, Sparrow Pharmaceuticals, Shionogi, Regor Pharmaceuticals, Innovent Biologics, Pfizer, NodThera Limited, Boehringer Ingelheim, Fractyl Health, TransThera, Clearmind Medicine, PegBio, Biolingus, and others. Promising Obesity Therapies such as APHD-012, Bimagrumab, Semaglutide, CT-868, GLY-200, Bremelanotide, and others. Discover how the Obesity treatment paradigm is evolving. Access DelveInsight's in-depth Obesity Pipeline Analysis for a closer look at promising breakthroughs @ Obesity Clinical Trials and Studies Obesity Emerging Drugs Survodutide: Zealand Pharma Survodutide (BI 456906) is a long-acting glucagon/GLP-1 receptor dual agonist for once-weekly subcutaneous administration that activates two key gut hormone receptors simultaneously and may offer better efficacy than current single-hormone receptor agonist treatments. Survodutide is targeting the treatment of obesity and nonalcoholic steatohepatitis (NASH). Boehringer Ingelheim is advancing survodutide into three global Phase III trials in people living with overweight or obesity. Ecnoglutide: Sciwind Biosciences Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. Ecnoglutide (XW003) is a novel, cAMP signaling biased, long-acting GLP-1 analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Obesity. CT-868: Carmot Therapeutics CT-868 is a dual GLP-1 and GIP receptor modulator with a unique pharmacological profile optimized for improved tolerability at the GLP-1 receptor. The combined action of GLP-1 and GIP results in greater body weight loss and glucose control. CT-868 is dosed once daily to maximize efficacy and tolerability. CT-868 dual agonist candidate was discovered using the chemotype evolution technology as a peptide-small molecule hybrid compound, able to mimic the native GLP-1 hormone. In the Phase I trial, CT-868 demonstrated compelling pharmacodynamic activity across several clinical measures in overweight and obese healthy individuals a safe and generally well-tolerated profile. Carmot Therapeutics is now expanding the observations in overweight and obese patients with type 2 diabetes to demonstrate CT-868's effects on glycemic control, weight loss, and tolerability. Currently, the drug is in the Phase II stage of development to treat obesity. DD01: D&D Pharmatech DD01 is a proprietary, imbalanced dual agonist of GLP-1 and glucagon receptors with a half-life of 11 days in non-human primates. DD01 is being developed as a potential disease-modifying agent for obesity and liver fatty disease. Treatment with DD01 caused weight loss, reduced liver fat, and improved glucose tolerance in preclinical obesity, diabetes, and fatty liver models. In preclinical models of diabetes and nonalcoholic fatty liver disease (NAFLD), DD01 could reduce weight and blood sugar and improve insulin sensitivity and lipid and fat metabolism, which could ameliorate NASH. DD01 demonstrated greater efficacy in preclinical models than semaglutide, an approved GLP-1R receptor agonist; from a mechanical perspective, the effect of DD01 persisted after cessation of treatment. It is currently being evaluated in Phase I clinical trial to investigate the safety, tolerability, PK, and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD). The Obesity pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Obesity with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Obesity Treatment. Obesity Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Obesity Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Obesity market. Get a detailed analysis of the latest innovations in the Obesity pipeline. Explore DelveInsight's expert-driven report today! @ Obesity Unmet Needs Obesity Companies Zealand Pharma, Sciwind Biosciences, Genexine, Sirnaomics, Sparrow Pharmaceuticals, Shionogi, Regor Pharmaceuticals, Innovent Biologics, Pfizer, NodThera Limited, Boehringer Ingelheim, Fractyl Health, TransThera, Clearmind Medicine, PegBio, Biolingus, and others. Obesity pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Obesity Products have been categorized under various ROAs such as Oral Parenteral Intravenous Subcutaneous Topical Obesity Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Download DelveInsight's latest report to gain strategic insights into upcoming Obesity Therapies and key Obesity Developments @ Obesity Market Drivers and Barriers, and Future Perspectives Scope of the Obesity Pipeline Report Coverage- Global Obesity Companies- Zealand Pharma, Sciwind Biosciences, Genexine, Sirnaomics, Sparrow Pharmaceuticals, Shionogi, Regor Pharmaceuticals, Innovent Biologics, Pfizer, NodThera Limited, Boehringer Ingelheim, Fractyl Health, TransThera, Clearmind Medicine, PegBio, Biolingus, and others. Obesity Therapies- APHD-012, Bimagrumab, Semaglutide, CT-868, GLY-200, Bremelanotide, and others. Obesity Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Obesity Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in Obesity drug development? Find out in DelveInsight's exclusive Obesity Pipeline Report—access it now! @ Obesity Emerging Drugs and Major Companies Table of Contents Introduction Executive Summary Obesity Overview Obesity Pipeline Therapeutics Obesity Therapeutic Assessment Late Stage Products (Phase III) Survodutide: Zealand Pharma Drug profiles in the detailed report….. Mid Stage Products (Phase II) CT-868: Carmot Therapeutics Drug profiles in the detailed report….. Early Stage Products (Phase I) DD01: D&D Pharmatech Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Obesity Products Obesity Key Companies Obesity Key Products Obesity Unmet Needs Obesity Market Drivers Obesity Market Barriers Obesity Future Perspectives and Conclusion Obesity Analyst Views Obesity Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Globe and Mail
2 hours ago
- Globe and Mail
Dr. Konstantinos Zarkadas Launches National Scholarship to Empower Aspiring Medical Leaders
Transformative Initiative Offers Financial Support to Future Physicians Committed to Service and Excellence GLEN COVE, NEW YORK - June 20, 2025 - In a bold step toward fostering the next generation of compassionate, driven medical professionals, Dr. Konstantinos Zarkadas, a respected leader in the healthcare sector, proudly announces the inauguration of the Dr. Konstantinos Zarkadas Scholarship for Future Doctors. This prestigious national scholarship aims to identify, support, and inspire undergraduate students who exhibit exceptional academic ability, a deep commitment to medicine, and a dedication to improving community health outcomes. The scholarship will award a one-time $1,000 grant to a single undergraduate student who meets the rigorous eligibility criteria. Applications are now open, with the deadline set for November 15, 2025. The recipient will be publicly announced on December 15, 2025. 'The future of medicine depends on individuals who lead with both intellect and empathy,' said Dr. Konstantinos Zarkadas. 'Through this scholarship, I hope to ease the financial burdens faced by aspiring doctors while encouraging them to embrace the calling of medical service with integrity, leadership, and vision. This is not just an award—it is an investment in the future of healthcare.' Dr. Zarkadas brings over two decades of experience in clinical practice and medical leadership. His academic journey, which includes a degree in Psychology from Hunter College, advanced medical training in the Dominican Republic, and a Master of Health Administration from Columbia University, has shaped his unique perspective on holistic and inclusive healthcare delivery. Currently serving as Chief Medical Officer at Arch Sleep Apnea Solutions and leading multiple medical practices, Dr. Konstantinos Zarkadas is deeply committed to transforming community health through culturally competent and patient-centered care. The Dr. Konstantinos Zarkadas Scholarship for Future Doctors has been thoughtfully designed to recognize students who combine academic excellence with a strong sense of social responsibility. Eligible applicants must meet the following criteria: Current Undergraduate Enrollment: Students must be enrolled at an accredited U.S. college or university. Pre-Medical Focus: Candidates must be pursuing a pre-med track or a closely related field, with clear intent to enter medical school. Academic Performance: A minimum cumulative GPA of 3.5 is required. Residency: Open to U.S. citizens and permanent residents. Leadership and Service: Applicants should demonstrate leadership potential and a history of meaningful community involvement. Commitment to Medicine: Candidates must clearly articulate their passion for medicine and dedication to a career in healthcare. Fluent in English, Greek, and Spanish, Dr. Konstantinos Zarkadas has long been an advocate for health equity and multicultural competence in medical practice. His past collaborations with organizations like Somos Community Care ACO and his leadership role in medical education at The New Parkway Hospital underscore his unwavering mission to mentor and empower the next wave of healthcare providers. Unlike many geographically limited programs, this scholarship is open to qualified students nationwide. Applicants must submit an original essay reflecting on their motivation to pursue medicine, their experiences in community service, and their vision for contributing meaningfully to the healthcare field. This narrative component is central to the selection process, allowing students to highlight not only their achievements but their potential for lasting impact. Comprehensive application guidelines and submission instructions can be found at: By championing students who exemplify both academic rigor and humanitarian values, the Dr. Konstantinos Zarkadas Scholarship for Future Doctors seeks to elevate the standards of tomorrow's medical profession. This initiative affirms Dr. Zarkadas's enduring belief that investing in education and ethical leadership is the surest path to a stronger, more inclusive American healthcare system. Media Contact Company Name: Dr. Konstantinos Zarkadas Scholarship Contact Person: Dr. Konstantinos Zarkadas Email: Send Email City: GLEN COVE State: NEW YORK Country: United States Website:
