SIGA Updates on Progress Its Smallpox Drug Trials For Potential Use Against Monkeypox

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  • SIGA Technologies Inc SIGA provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox.
  • In recent weeks, the company initiated trials in the U.S., the U.K., and Congo to further assess the safety and efficacy of TPOXX in participants with monkeypox. 
  • These randomized clinical trials are now enrolling patients.
    • Study of Tecovirimat for Human Monkeypox Virus (STOMP; A5418) is a U.S.-based clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Study investigators aim to enroll more than 500 participants, including children.
    • PLATINUM is a U.K.-based clinical trial commissioned and funded by the National Institute for Health Care and Research (NIHR), intending to recruit at least 500 participants.
    • PALM 007 is a Congo-based clinical trial sponsored by NIAID and Institute National de Recherche Biomédicale (INRB). Study investigators aim to enroll more than 450 participants, including children weighing ≥3 kg and those who are pregnant or breastfeeding.
  • In 2018, the FDA approved oral TPOXX for smallpox.
  • SIGA disclosed that as of mid-September, it received approximately $76 million of international orders for oral TPOXX from twelve international customers.
  • Price Action: SIGA shares are down 0.17% at $9.08 during the market session on the last check Thursday.
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