Latest news with #antiviral
Globe and Mail
5 days ago
- Business
- Globe and Mail
Pfizer's PAXLOVID Study: Real-World Insights on COVID-19 Treatment
Pfizer Inc ((PFE)) announced an update on their ongoing clinical study. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Pfizer Inc. is conducting a study titled 'Post Marketing Surveillance to Observe Safety and Effectiveness of PAXLOVID in Patients With Positive Results of Viral Testing, and Who Are at High Risk for Progression to Severe COVID-19.' The study aims to assess the real-world safety and effectiveness of PAXLOVID in patients at high risk of severe COVID-19, particularly in Korea. This is significant as it provides insights into the drug's performance outside controlled clinical settings. The intervention being tested is PAXLOVID, an antiviral treatment intended to reduce the severity of COVID-19 in high-risk patients. The study focuses on patients who have tested positive for the virus and are at risk of severe outcomes, including hospitalization or death. This observational study follows a case-only model and does not involve any specific allocation or masking. The primary purpose is to gather real-world data on PAXLOVID's effectiveness and safety over a 28-day follow-up period after treatment. The study began on November 29, 2023, with its primary completion and estimated study completion dates yet to be announced. The last update was submitted on July 22, 2025, highlighting ongoing data collection and analysis. Market implications of this study are significant for Pfizer's stock performance as positive real-world data could bolster investor confidence and market position against competitors. The study's outcomes may influence healthcare providers' decisions and potentially increase PAXLOVID's market share. The study is currently recruiting, with further details available on the ClinicalTrials portal.
Yahoo
16-07-2025
- Health
- Yahoo
ArkBio's Ziresovir Included into Pediatric RSV Drug Priority List by WHO
SHANGHAI, July 15, 2025 /PRNewswire/ -- In the newly released "Paediatric drug optimization for respiratory syncytial virus (PADO-RSV) meeting report" by Global Accelerator for Paediatric formulations (GAP-f), the World Health Organization (WHO) host network, ziresovir (10mg) has been included in the PADO-RSV priority list. Ziresovir, developed by Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio"), is the first and only RSV antiviral drug to be included in the list. This is the first time WHO has included an anti-RSV drug developed from China in the paediatric drug optimization priority list. Filling a Global Gap: Ziresovir Leads RSV Antiviral Development RSV is the leading pathogen of lower respiratory tract infections (LRTIs) in infants and young children globally, causing approximately 33 million cases of LRTIs, 3.6 million hospitalizations, and 101,400 deaths annually, with 97% of deaths occurring in low- and middle-income countries (LMICs). Despite the severe threat, current specific treatment options for RSV are extremely limited, and there is a clinical urgent need for safe, effective, and child-appropriate innovative drugs. The "Paediatric drug optimization for respiratory syncytial virus (PADO-RSV)" project initiated by WHO/GAP-f aims to systematically review the global R&D pipeline, clarify R&D priorities, and promote the development and accessibility of RSV prevention and treatment tools more suitable for the paediatric population. With its clear clinical value, child-friendly design, and good safety profile, ziresovir becomes the only product in the antiviral drug category selected for the PADO-RSV priority list, demonstrating its huge potential in the paediatric RSV treatment globally. WHO pointed out in the report that ziresovir's research results are of great significance to the global RSV treatment field and recommended conducting diverse clinical studies in broader populations to further verify its applicability and effectiveness. ArkBio will actively respond to WHO's advice with a plan to expand ziresovir's clinical development in other countries and regions. By collaborating with international scientific institutions and public health organizations, ArkBio aims to rapidly advance the drug's global registration and accessibility. Simultaneously, ArkBio is deeply aware of the importance of global public health, particularly concerned about the challenges faced by low- and middle-income countries. The company will formulate drug accessibility plans specifically for these countries to ensure ziresovir can be supplied at reasonable prices globally wherever it is needed, contributing to the prevention and treatment of RSV infection. "ArkBio has a mission to 'help patients inspire and thrive'", Dr. Jim Wu, CEO of ArkBio, stated. "The inclusion of ziresovir in the WHO PADO-RSV priority list is not only an affirmation of the years of effort by ArkBio scientists, but also an inspiration for our corporate mission. The recognition of ziresovir would allow us to expedite its global development and realize the potential on the global stage. We will ensure the innovation can not only benefit patients in China but the very needed patients worldwide. This is not just our goal but our social responsibility. ArkBio will strive to contribute more to address global public health issues." About GAP-f GAP-f stands for the Global Accelerator for Paediatric Formulations Network. Hosted by WHO, it operates throughout the drug development lifecycle to accelerate the research, development, and dissemination of optimized pediatric formulations. Identifying priorities is the first step toward a targeted R&D approach. Establishing a priority list of the most urgently needed pediatric formulations is crucial, as it helps focus the efforts and resources of researchers and suppliers on specific dosage forms and formulations that address children's most critical needs. About PADO PADO stands for Paediatric Drug Optimization. It is a WHO's legally binding international priority (based on WHA69.20 resolution) that accelerates the development of high-demand pediatric drugs by building consensus among regulators, funders, and manufacturers. It aims to identify priority products for R&D and define their ideal characteristics. It has been successfully implemented in areas including human immunodeficiency virus (HIV), hepatitis C, tuberculosis, COVID-19, antibiotics, neglected tropical diseases, and childhood cancers. These initiatives demonstrate that, against the backdrop of a fragmented and small pediatric drug market, such efforts hold potential and deliver tangible impacts in accelerating access to optimized formulations. About Ziresovir Ziresovir is a novel small-molecule RSV fusion (F) protein inhibitor. It binds to the pre-F protein conformation of the virus and prevents viral entry into human cells. Ziresovir can also suppress RSV viral transmission by blocking cell-to-cell fusion through the formation of "syncytia", a characteristic event of RSV infection of host cells. It is the first oral anti-RSV drug that has completed a phase 3 pivotal clinical study with positive results. The phase 3 results have been published in The New England Journal of Medicine and The Lancet Child & Adolescent Health. Ziresovir has received Breakthrough Therapy designation by the National Medical Products Administration (NMPA) of China. About ArkBio ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and Azstarys (AK0901), an FDA-approved ADHD therapeutic drug. ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions. For more information, please visit: Inquiries: IR@ View original content to download multimedia: SOURCE Arkbio 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
12-07-2025
- Business
- Yahoo
Gilead Sciences, Inc. (GILD): A Bull Case Theory
We came across a bullish thesis on Gilead Sciences, Inc. on Dividend Talks's Substack. In this article, we will summarize the bulls' thesis on GILD. Gilead Sciences, Inc.'s share was trading at $110.87 as of June 30th. GILD's trailing and forward P/E were 23.29 and 14.01 respectively according to Yahoo Finance. A doctor holding a vial of medication related to antiviral treatments in a medical office. Gilead Sciences (GILD) is a leading biopharmaceutical company known for its expertise in antiviral therapies, particularly in HIV, hepatitis C, and increasingly, oncology. The company gained prominence during the COVID-19 pandemic through its antiviral drug remdesivir, which was one of the first approved treatments for the virus. Despite its scientific and commercial accomplishments, Gilead has underperformed the S&P 500 over the past decade, reflecting investor concerns around growth and pipeline execution. Currently, GILD trades at a forward P/E of 13.6x, above its five-year average of 10.5x, suggesting that some optimism may already be priced in. However, the stock is still considered to offer a 10% margin of safety at its current trading price of $107, providing potential downside protection for value-focused investors. Wall Street analysts see modest 8% upside over the next year, reflecting cautious optimism. While not a high-growth story, Gilead's stable revenue base from its HIV franchise, growing oncology pipeline, and disciplined capital allocation make it a steady compounder with defensive characteristics. The valuation, while richer than historical norms, remains reasonable in the context of the broader healthcare sector. GILD may not offer explosive upside, but it stands out as a relatively low-risk name with dependable cash flows and a track record of innovation in therapeutic areas with enduring demand. The current setup makes it a solid choice for long-term investors seeking exposure to biotech with a margin of safety and modest upside, supported by consistent execution and a diversified therapeutic portfolio. Previously we covered a on Gilead Sciences, Inc. by Disruptive Analytics in Feb 2025, which highlighted cost discipline amid revenue headwinds from policy, currency, and COVID declines. The stock has appreciated ~6.5% since as those challenges were priced in. Dividend Talks shares a similar view but emphasizes Gilead's margin of safety and steady long-term appeal. GILD isn't on our list of the 30 Most Popular Stocks Among Hedge Funds. While we acknowledge the risk and potential of GILD as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
Associated Press
07-07-2025
- Business
- Associated Press
NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
NanoViricides, Inc. (NYSE Amer.: NNVC), a clinical-stage biopharmaceutical company and a pioneer in broad-spectrum antivirals, announced today its accelerated plans to advance its lead drug candidate, NV-387, into Phase II clinical trials for MPox. This strategic decision positions the company to potentially bring a much-needed antiviral to market faster, addressing a critical global health need while also paving the way for further pipeline development. NanoViricides highlighted several key reasons for prioritizing MPox as the first indication for NV-387's Phase II development, even with strong efficacy data in animal studies for other major viral threats like RSV, Influenza, and COVID. Strategic Advantages of the MPox Focus The company believes its focus on MPox offers significant advantages: Urgent Need and Timely Trial Completion: With a continuing MPox epidemic in the African Region, there's a pressing demand for effective treatments. This also facilitates patient recruitment, enabling a more rapid completion of the clinical trial. Cost-Effectiveness: Conducting clinical trials in the African Region is substantially more economical compared to the US or Europe, allowing NanoViricides to optimize its research budget. Validation of Animal Model Data: A successful Phase II trial for MPox in humans would validate the company's use of lethal challenge animal models. This is a critical point, as NanoViricides' animal studies have consistently shown NV-387 to be significantly superior to existing drugs across all tested infections. Strong Financial and Public Health Case: The recent failure of tecovirimat (Tpoxx) in MPox clinical trials creates a clear void in the US Strategic National Stockpile (SNS) for effective antivirals against orthopoxviruses like MPox and Smallpox. Both tecovirimat and brincidofovir (Tembexa), currently approved for Smallpox under the 'FDA Animal Rule,' have shown limitations. Brincidofovir failed due to liver toxicity, and tecovirimat demonstrated no superiority over standard care. NanoViricides believes NV-387 could become a crucial addition to the SNS, potentially securing substantial initial acquisition contracts. Addressing a Critical Vulnerability: Unlike small chemical drugs that viruses can readily escape through mutations, NanoViricides' host-mimetic nanomedicine technology is designed to make it difficult for viruses to develop resistance. This is particularly important for bioterrorism readiness, as manipulated forms of viruses like Smallpox could be engineered to resist conventional treatments. The company emphasizes the strong case for the US Department of Health and Human Services (HHS) to support NV-387 development for bioterrorism preparedness. Innovative Drug Delivery Adding to its strategic advantages, NV-387 will be administered as 'NV-387 Oral Gummies.' This soft solid formulation is designed to dissolve naturally in the oral cavity, eliminating the need for swallowing pills or capsules. This is a significant benefit for MPox patients who often suffer from painful oral lesions, making swallowing difficult. Addressing the Broader MPox Threat The ongoing MPox epidemic in the Democratic Republic of Congo (DRC) is driven by Clade 1a and the more transmissible Clade 1b subtypes, which have higher case fatality rates than the Clade 2b circulating in the Western world. While sporadic Clade 1 cases have been reported in the USA without further spread, the potential for a larger epidemic cannot be ignored. NanoViricides asserts that readiness with an effective drug against Clade 1 MPox is crucial for national health security. NanoViricides, Inc. is a publicly traded clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company's innovative nanoviricide™ class of drug candidates is based on technology and proprietary know-how from TheraCour Pharma, Inc. Other notable stocks to keep on top of radar include Summit Therapeutics (SMMT), Regulus Therapeutics (RGLS), Vigil Neuroscience (VIGL), Alaunos Therapeutics (TCRT), CervoMed Inc. (CRVO), Niagen Bioscience (NAGE) and Beam Therapeutics (BEAM). Source: Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of BURU or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated fifteen hundred dollars by a 3rd party EDM Media Consulting Group for content distribution services on nnvc or July 6th, 2025. is neither an investment advisor nor a registered broker. No current owner, employee, or independent contractor of is registered as a securities broker-dealer, broker, investment advisor, or IA representative with the U.S. Securities and Exchange Commission, any state securities regulatory authority, or any self-regulatory organization. This article may contain forward-looking statements as defined under Section 27A of the Securities Act of 1933 and 21E of the Exchange Act of 1934. These statements, often incorporating terms like 'believes,' 'anticipates,' 'estimates,' 'expects,' 'projects,' 'intends,' or similar expressions about future performance or conduct, are based on present expectations, estimates, and projections, and are not historical facts. They carry various risks and uncertainties that may result in significant deviation from the anticipated results or events. Past performance does not guarantee future does not commit to updating forward-looking statements based on new information or future events. Readers are encouraged to review all public SEC filings made by the profiled companies at It is always important to conduct thorough due diligence and exercise caution in is not managed by a licensed broker, a dealer, or a registered investment adviser. The content here is purely informational and should not be taken as investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor regarding forward-looking statements. Any statement that projects, foresees, expects, anticipates, estimates, believes, or understands certain actions to possibly occur are not historical facts and may be forward-looking statements. These statements are based on expectations, estimates, and projections that could cause actual results to differ greatly from those anticipated. Investing in micro-cap and growth securities is speculative and entails a high degree of risk, potentially leading to a total or substantial loss of investment. Please note that no content published here constitutes a recommendation to buy or sell a security. It is solely informational, and you should not construe it as legal, tax, investment, financial, or other advice. No content in this article constitutes an offer or solicitation by or any third-party service provider to buy or sell securities or other financial instruments. The content in this article does not address the circumstances of any specific individual or entity and does not constitute professional and/or financial advice. is not a fiduciary by virtue of any person's use of or access to this content. This article is for informational purposes only and does not constitute investment advice. Always conduct your own research before making investment decisions. This analysis represents the opinion of the author based on publicly available information and should not be considered investment advice. Investors should conduct their own due diligence before making investment decisions. Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: [email protected] City: Frisco State: Texas Country: United States Website: Press Release Distributed by To view the original version on ABNewswire visit: NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
Globe and Mail
07-07-2025
- Business
- Globe and Mail
NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
NanoViricides, Inc. (NYSE Amer.: NNVC), a clinical-stage biopharmaceutical company and a pioneer in broad-spectrum antivirals, announced today its accelerated plans to advance its lead drug candidate, NV-387, into Phase II clinical trials for MPox. This strategic decision positions the company to potentially bring a much-needed antiviral to market faster, addressing a critical global health need while also paving the way for further pipeline development. NanoViricides highlighted several key reasons for prioritizing MPox as the first indication for NV-387's Phase II development, even with strong efficacy data in animal studies for other major viral threats like RSV, Influenza, and COVID. Strategic Advantages of the MPox Focus The company believes its focus on MPox offers significant advantages: Urgent Need and Timely Trial Completion: With a continuing MPox epidemic in the African Region, there's a pressing demand for effective treatments. This also facilitates patient recruitment, enabling a more rapid completion of the clinical trial. Cost-Effectiveness: Conducting clinical trials in the African Region is substantially more economical compared to the US or Europe, allowing NanoViricides to optimize its research budget. Validation of Animal Model Data: A successful Phase II trial for MPox in humans would validate the company's use of lethal challenge animal models. This is a critical point, as NanoViricides' animal studies have consistently shown NV-387 to be significantly superior to existing drugs across all tested infections. Strong Financial and Public Health Case: The recent failure of tecovirimat (Tpoxx) in MPox clinical trials creates a clear void in the US Strategic National Stockpile (SNS) for effective antivirals against orthopoxviruses like MPox and Smallpox. Both tecovirimat and brincidofovir (Tembexa), currently approved for Smallpox under the "FDA Animal Rule," have shown limitations. Brincidofovir failed due to liver toxicity, and tecovirimat demonstrated no superiority over standard care. NanoViricides believes NV-387 could become a crucial addition to the SNS, potentially securing substantial initial acquisition contracts. Addressing a Critical Vulnerability: Unlike small chemical drugs that viruses can readily escape through mutations, NanoViricides' host-mimetic nanomedicine technology is designed to make it difficult for viruses to develop resistance. This is particularly important for bioterrorism readiness, as manipulated forms of viruses like Smallpox could be engineered to resist conventional treatments. The company emphasizes the strong case for the US Department of Health and Human Services (HHS) to support NV-387 development for bioterrorism preparedness. Innovative Drug Delivery Adding to its strategic advantages, NV-387 will be administered as "NV-387 Oral Gummies." This soft solid formulation is designed to dissolve naturally in the oral cavity, eliminating the need for swallowing pills or capsules. This is a significant benefit for MPox patients who often suffer from painful oral lesions, making swallowing difficult. Addressing the Broader MPox Threat The ongoing MPox epidemic in the Democratic Republic of Congo (DRC) is driven by Clade 1a and the more transmissible Clade 1b subtypes, which have higher case fatality rates than the Clade 2b circulating in the Western world. While sporadic Clade 1 cases have been reported in the USA without further spread, the potential for a larger epidemic cannot be ignored. NanoViricides asserts that readiness with an effective drug against Clade 1 MPox is crucial for national health security. NanoViricides, Inc. is a publicly traded clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company's innovative nanoviricide™ class of drug candidates is based on technology and proprietary know-how from TheraCour Pharma, Inc. Other notable stocks to keep on top of radar include Summit Therapeutics (SMMT), Regulus Therapeutics (RGLS), Vigil Neuroscience (VIGL), Alaunos Therapeutics (TCRT), CervoMed Inc. (CRVO), Niagen Bioscience (NAGE) and Beam Therapeutics (BEAM). Source: Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of BURU or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated fifteen hundred dollars by a 3rd party EDM Media Consulting Group for content distribution services on nnvc or July 6th, 2025. is neither an investment advisor nor a registered broker. No current owner, employee, or independent contractor of is registered as a securities broker-dealer, broker, investment advisor, or IA representative with the U.S. Securities and Exchange Commission, any state securities regulatory authority, or any self-regulatory organization. This article may contain forward-looking statements as defined under Section 27A of the Securities Act of 1933 and 21E of the Exchange Act of 1934. These statements, often incorporating terms like 'believes,' 'anticipates,' 'estimates,' 'expects,' 'projects,' 'intends,' or similar expressions about future performance or conduct, are based on present expectations, estimates, and projections, and are not historical facts. They carry various risks and uncertainties that may result in significant deviation from the anticipated results or events. Past performance does not guarantee future does not commit to updating forward-looking statements based on new information or future events. Readers are encouraged to review all public SEC filings made by the profiled companies at It is always important to conduct thorough due diligence and exercise caution in is not managed by a licensed broker, a dealer, or a registered investment adviser. The content here is purely informational and should not be taken as investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor regarding forward-looking statements. Any statement that projects, foresees, expects, anticipates, estimates, believes, or understands certain actions to possibly occur are not historical facts and may be forward-looking statements. These statements are based on expectations, estimates, and projections that could cause actual results to differ greatly from those anticipated. Investing in micro-cap and growth securities is speculative and entails a high degree of risk, potentially leading to a total or substantial loss of investment. Please note that no content published here constitutes a recommendation to buy or sell a security. It is solely informational, and you should not construe it as legal, tax, investment, financial, or other advice. No content in this article constitutes an offer or solicitation by or any third-party service provider to buy or sell securities or other financial instruments. The content in this article does not address the circumstances of any specific individual or entity and does not constitute professional and/or financial advice. is not a fiduciary by virtue of any person's use of or access to this content. This article is for informational purposes only and does not constitute investment advice. Always conduct your own research before making investment decisions. This analysis represents the opinion of the author based on publicly available information and should not be considered investment advice. Investors should conduct their own due diligence before making investment decisions. Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: editor@ City: Frisco State: Texas Country: United States Website:
