Tecovirimat

SHELTON, CONNECTICUT / ACCESS Newswire / February 12, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American: NNVC ) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox" with the US FDA Office of Orphan Products Development (OOPD). If approved, orphan drug designation will qualify NanoViricides for incentives including: Tax credits for qualified clinical trials; Exemption from certain user fees; Potential seven years of market exclusivity after approval; according to the US FDA ( ). "NV-387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat." WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus. MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern. There is no approved drug for the treatment of MPox. Tecovirimat (TPOXX®, SIGA) and brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule". Tecovirimat has failed to show any clinical effectiveness, and did not show any viral load reduction benefit either, over standard of care in a clinical trial for treatment of MPXV infections 1 . Mutants resistant to tecovirimat were found to be generated in some cases. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study" 2 . In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial 3 . The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results. The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles 4 . MPXV has continued to mutate in the African region. Mutants resistant to the JYNNEOS® Smallpox vaccine that was fielded to control the spread of MPXV Clade Ia/Ib have been found. The antibody response to MPXV from the JYNNEOS vaccine was found to be poor and short-lived 5 . The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX. NV-387 has shown strong effectiveness in a mouse model of dermal lethal infection of ectromelia, an orthopoxvirus closely related to viruses that cause smallpox and mpox. NV-387 has successfully completed a Phase I human clinical trial demonstrating safety and tolerability in healthy adults with no reported adverse events. Therefore the Company believes that NV-387 is a viable clinical candidate for the treatment of MPox. In the USA, MPOX incidence rate was approximately 2,042 cases in 2025, well below 200,000 cases 6 . Thus NV-387 for the Treatment of MPox qualifies for Orphan Drug Designation. NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors. NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles. Viral resistance to NV-387 is unlikely because this drug mimics specific cell-side features that these viruses continue to employ to effectively infect human host cells, despite how much they may change in the field. In contrast, viruses mutations readily result in making traditional vaccines, antibodies, and small chemical drugs ineffective. Further, NV-387 is a complete chemical nanomachine that completes the task of binding to, engulfing, and destroying virus particles without any dependence on the human immune system. These factors make NV-387 unique in the field of antiviral drugs and vaccines. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( ) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments. The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour ® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: ir@nanoviricides.com 1 The PALM007 Writing Group, "Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo", N Engl J Med 2025;392:1484-96. DOI: 10.1056/NEJMoa2412439. 2 Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network . 3 . 4 Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir. 5 Phipps, K. et al. "Short-Lived Neutralizing Antibody Responses to Monkeypox Virus in Smallpox Vaccine-Naive Persons after JYNNEOS Vaccination." Wadsworth Center, New York State Department of Health and Univ. of Albany, NY. Emerging Infectious Diseases • • Vol. 31, No. 2, February 2025. DOI: . 6 . SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire

来源：新浪证券-红岸工作室2月2日，优宁维跌0.61%，成交额4927.59万元，换手率2.63%，总市值28.05亿元。异动分析基因测序+医药电商+猴痘概念+细胞免疫治疗+重组蛋白1、根据公司官网，公司有单细胞DNA测序，单细胞RNA测序产品。2、2025年12月26日互动易，公司目前形成了线上+线下双渠道销售模式，线上渠道方面，主要通过自有商城、微信、抖音等平台以及第三方专业服务网站展示、销售公司产品，提升公司产品曝光度；此外针对海外市场，目前主要通过海外电商平台、参加海外展会等方式进行市场拓展。3、公司商城中在售的特考韦瑞、西多福韦，均用于科研领域，上述产品为公司爱必信旗下的ODM产品，非自产产品。目前上述产品对公司收入贡献很小。（注：国泰君安研报表示：根据美国CDC，目前尚无针对猴痘的特效疗法，但可结合天花疫苗，以及西多福韦、Brincidofovir、特考韦瑞、痘苗免疫球蛋白等药物，将猴痘疫情控制住。）4、公司在细胞治疗领域的产品主要为抗体及抗体相关试剂、其他生物科学试剂、仪器及耗材和综合技术服务。5、公司作为生命科学一站式服务商，面向高等院校、科研院所、医院和生物医药企业等，提供以抗体为核心的生命科学试剂及相关仪器、耗材和综合技术服务。公司抗体相关试剂产品包括基于抗体应用技术开发的检测试剂盒、重组蛋白/多肽、辅助试剂，重组蛋白主要作为添加剂用于细胞培养，或作为标准品用于定量检测试剂盒标准曲线的绘制等。公司产品和服务覆盖药物研发（以生物药为主，如抗体药、重组蛋白药、细胞治疗等）的药物发现、临床前研究、临床研究等各环节。(免责声明：分析内容来源于互联网，不构成投资建议，请投资者根据不同行情独立判断)资金分析今日主力净流入244.59万，占比0.05%，行业排名3/55，该股当前无连续增减仓现象，主力趋势不明显；所属行业主力净流入-7.14亿，连续3日被主力资金减仓。区间今日近3日近5日近10日近20日主力净流入244.59万58.06万190.56万-1420.23万-2474.61万 主力持仓主力没有控盘，筹码分布非常分散，主力成交额883.80万，占总成交额的3.89%。技术面：筹码平均交易成本为31.95元该股筹码平均交易成本为31.95元，近期该股有吸筹现象，但吸筹力度不强；目前股价靠近支撑位32.33，注意支撑位处反弹，若跌破支撑位则可能会开启一波下跌行情。公司简介资料显示，上海优宁维生物科技股份有限公司位于上海市浦东新区古丹路15弄16号楼，成立日期2004年10月22日，上市日期2021年12月28日，公司主营业务涉及面向高等院校、科研院所、医院和生物医药企业等,提供以抗体为核心的生命科学试剂及相关仪器、耗材和综合技术服务。主营业务收入构成为：生命科学试剂77.94%，生命科学仪器及耗材16.11%，综合技术服务5.95%。优宁维所属申万行业为：医药生物-生物制品-其他生物制品。所属概念板块包括：微盘股、小盘价值、基因测序、小盘、科学仪器等。截至9月30日，优宁维股东户数9893.00，较上期减少13.19%；人均流通股5753股，较上期增加15.19%。2025年1月-9月，优宁维实现营业收入7.76亿元，同比减少6.24%；归母净利润-1507.96万元，同比减少207.11%。分红方面，优宁维A股上市后累计派现1.82亿元。近三年，累计派现1.38亿元。机构持仓方面，截止2025年9月30日，优宁维十大流通股东中，诺安多策略混合A（320016）位居第八大流通股东，持股49.91万股，为新进股东。声明：市场有风险，投资需谨慎。本文基于第三方数据库自动发布，不代表新浪财经观点，任何在本文出现的信息均只作为参考，不构成个人投资建议。如有出入请以实际公告为准。如有疑问，请联系biz@staff.sina.com.cn。返回搜狐，查看更多