Latest news with #SIGA
Medscape
4 days ago
- Health
- Medscape
EMA Launches Review of Tecovirimat Effectiveness for Mpox
The European Medicines Agency (EMA) has initiated a review of Tecovirimat SIGA, also called TPOXX, a medicine used to treat mpox. This follows emerging clinical trial data suggesting a lack of effectiveness. The mpox virus is an orthopoxvirus, a class that includes the smallpox virus. Tecovirimat SIGA was originally approved in the US to treat smallpox. The EMA and the Medicines and Healthcare products Regulatory Agency in the UK authorized its use in January 2022, at the start of an mpox outbreak in Europe, for the treatment of smallpox, mpox, cowpox, and vaccinia complications following smallpox vaccination, in adults and children weighing at least 13 kg. The drug is an oral medicine that interferes with a protein called VP37 found on the surface of orthopoxviruses, preventing them from reproducing normally and thus slowing the spread of infection. No other treatments are authorized for mpox or cowpox infections, which may in rare cases be fatal. European Cases Linked With Risky Sexual Behaviors Mpox is a zoonotic infection occurring mainly in West and Central Africa, with most cases in Europe before 2022 either imported from countries where mpox is endemic or from contacts with documented epidemiological links to imported cases. The outbreak in the EU and UK has been transmitted between humans mainly through sexual contact. It primarily affects gay, bisexual, or other men who have sex with men and who have multiple sexual partners, participate in group sex, or attend sex-on-premises venues. Transmission occurs primarily within interconnected sexual networks. Symptoms of mpox typically appear 1-3 weeks after infection and include fever, headache, chills, physical weakness, lymph node swelling, back pain, and muscle aches, along with a distinct, fast-spreading papular rash on the skin and mucosal sores in the mouth, nose, throat, or digestive tract that then turn into fluid-filled vesicles. Mild-to-moderate symptoms usually last 2-4 weeks and are followed by full recovery, though some people develop permanent scars. During outbreaks, the case fatality of mpox ranges from 0% to 11%. People who are immunocompromised, including those with HIV infection or AIDS, are at a higher risk for severe disease. Exceptional Circumstances Approval During Outbreak Approval for Tecovirimat SIGA was granted under 'exceptional circumstances' provisions, based only on pharmacodynamic and pharmacokinetic studies, because the disease is rare and sporadic, so human studies were not available. A condition of such authorization is that the company marketing Tecovirimat SIGA is required to provide an annual update on benefits and risks. The EMA's review is a postauthorization procedure that involves a scientific assessment by the agency on behalf of the EU aimed at resolving issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In the case of Tecovirimat SIGA (tecovirimat), the review was initiated at the request of the European Commission. The review follows publication of preliminary results from two clinical trials. In the randomized, placebo-controlled PALM007 trial involving 597 children and adults with laboratory-confirmed clade I mpox in the Democratic Republic of the Congo (DRC), results reported in April in The New England Journal of Medicine showed that the drug did not reduce the duration of mpox lesions (median time to resolution, 7 vs 8 days). The overall mortality among enrollees, regardless of whether or not they received the drug, was 1.6% — much lower than that generally reported in the DRC, but this was attributed to hospitalization and high-quality supportive care within the trial. The other trial, STOMP, involved people from multiple countries with mild-to-moderate laboratory-confirmed or presumptive clade II mpox. Again, the active drug did not demonstrate efficacy in time to skin and mucosal lesion resolution compared with placebo. The EMA said that similar results had recently been obtained from another study, UNITY, which also did not indicate faster skin lesion resolution on tecovirimat compared with placebo. Further analyses from ongoing or recently completed studies are still awaited and will also inform the EMA's final assessment.
Yahoo
5 days ago
- Business
- Yahoo
Siga Technologies Inc. (SIGA) Stock Falls Amid Market Uptick: What Investors Need to Know
Siga Technologies Inc. (SIGA) ended the recent trading session at $7.06, demonstrating a -1.4% change from the preceding day's closing price. The stock's performance was behind the S&P 500's daily gain of 0.07%. On the other hand, the Dow registered a loss of 0.7%, and the technology-centric Nasdaq increased by 0.18%. The stock of company has risen by 11.18% in the past month, leading the Medical sector's gain of 2.39% and the S&P 500's gain of 5.71%. The investment community will be paying close attention to the earnings performance of Siga Technologies Inc. in its upcoming release. Looking at the full year, the Zacks Consensus Estimates suggest analysts are expecting earnings of $0.13 per share and revenue of $184.36 million. These totals would mark changes of -84.15% and +32.97%, respectively, from last year. Investors should also pay attention to any latest changes in analyst estimates for Siga Technologies Inc. Recent revisions tend to reflect the latest near-term business trends. As such, positive estimate revisions reflect analyst optimism about the business and profitability. Our research shows that these estimate changes are directly correlated with near-term stock prices. To take advantage of this, we've established the Zacks Rank, an exclusive model that considers these estimated changes and delivers an operational rating system. The Zacks Rank system, running from #1 (Strong Buy) to #5 (Strong Sell), holds an admirable track record of superior performance, independently audited, with #1 stocks contributing an average annual return of +25% since 1988. Over the past month, there's been no change in the Zacks Consensus EPS estimate. Siga Technologies Inc. currently has a Zacks Rank of #3 (Hold). In terms of valuation, Siga Technologies Inc. is currently trading at a Forward P/E ratio of 55.08. This valuation marks a premium compared to its industry average Forward P/E of 14.4. The Medical - Drugs industry is part of the Medical sector. This group has a Zacks Industry Rank of 89, putting it in the top 37% of all 250+ industries. The Zacks Industry Rank assesses the strength of our separate industry groups by calculating the average Zacks Rank of the individual stocks contained within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1. Keep in mind to rely on to watch all these stock-impacting metrics, and more, in the succeeding trading sessions. 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 Siga Technologies Inc. (SIGA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Melden Sie sich an, um Ihr Portfolio aufzurufen.
Yahoo
17-07-2025
- Business
- Yahoo
Siga Technologies Inc. (SIGA) Outpaces Stock Market Gains: What You Should Know
Siga Technologies Inc. (SIGA) closed the most recent trading day at $6.78, moving +1.19% from the previous trading session. The stock exceeded the S&P 500, which registered a gain of 0.32% for the day. Elsewhere, the Dow gained 0.53%, while the tech-heavy Nasdaq added 0.26%. Prior to today's trading, shares of the company had gained 6.35% outpaced the Medical sector's loss of 3.4% and the S&P 500's gain of 4.51%. The investment community will be paying close attention to the earnings performance of Siga Technologies Inc. in its upcoming release. For the full year, the Zacks Consensus Estimates project earnings of $0.13 per share and a revenue of $184.36 million, demonstrating changes of -84.15% and +32.97%, respectively, from the preceding year. Any recent changes to analyst estimates for Siga Technologies Inc. should also be noted by investors. These revisions typically reflect the latest short-term business trends, which can change frequently. As a result, upbeat changes in estimates indicate analysts' favorable outlook on the business health and profitability. Research indicates that these estimate revisions are directly correlated with near-term share price momentum. To utilize this, we have created the Zacks Rank, a proprietary model that integrates these estimate changes and provides a functional rating system. The Zacks Rank system, which ranges from #1 (Strong Buy) to #5 (Strong Sell), has an impressive outside-audited track record of outperformance, with #1 stocks generating an average annual return of +25% since 1988. Over the last 30 days, the Zacks Consensus EPS estimate has remained unchanged. As of now, Siga Technologies Inc. holds a Zacks Rank of #3 (Hold). From a valuation perspective, Siga Technologies Inc. is currently exchanging hands at a Forward P/E ratio of 51.54. This valuation marks a premium compared to its industry average Forward P/E of 13.09. The Medical - Drugs industry is part of the Medical sector. This industry currently has a Zacks Industry Rank of 96, which puts it in the top 39% of all 250+ industries. The Zacks Industry Rank gauges the strength of our individual industry groups by measuring the average Zacks Rank of the individual stocks within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1. Don't forget to use to keep track of all these stock-moving metrics, and others, in the upcoming trading sessions. 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 Siga Technologies Inc. (SIGA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Miami Herald
14-07-2025
- Business
- Miami Herald
Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides
SHELTON, CT / ACCESS Newswire / July 14, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: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, announces that the design of the adaptive clinical trial protocol for the treatment of MPox Virus Clade Ia and Ib infections and disease is nearly complete. The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial: safe and effective dosing regimen in patients,safety and tolerability of the drug in patients, andantiviral effectiveness of the drug in patients. The overall clinical trial will enroll approximately 80 patients. "This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease." Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease. NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus. If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions. MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits. Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC [1] . The adaptive, randomized, SOC controlled clinical trial will proceed in two parts: In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease. There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results. In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy. The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region. The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash. Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial. Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found. The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about 3%-11% whereas the CFR for Clade 1b is about 1%. The MPox Clade 2b is the virus causing continuing cases in the Western world, which causes a much less severe disease than Clade 1a/1b and has a very low CFR, according to CDC. Sporadic cases of Clade 1 in the Western world continue to occur. Four separate travel-related MPox Clade 1 cases reported in the USA that did not result in any further spread, since November 2024, according to the CDC [3] . Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve. 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, Public Relations Contact:ir@
Yahoo
10-05-2025
- Business
- Yahoo
SIGA Technologies First Quarter 2025 Earnings: US$0.006 loss per share (vs US$0.14 profit in 1Q 2024)
Revenue: US$7.04m (down 72% from 1Q 2024). Net loss: US$408.2k (down by 104% from US$10.3m profit in 1Q 2024). US$0.006 loss per share (down from US$0.14 profit in 1Q 2024). We check all companies for important risks. See what we found for SIGA Technologies in our free report. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 43% p.a. on average during the next 2 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Performance of the American Pharmaceuticals industry. The company's share price is broadly unchanged from a week ago. While earnings are important, another area to consider is the balance sheet. See our latest analysis on SIGA Technologies' balance sheet health. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
