SIGA Technologies is focused on the treatment of smallpox and other orthopoxviruses. It has contracts with the US and Canadian governments for TPOXX, its treatment for smallpox and is looking to expand internationally. As the leading smallpox therapeutic manufacturer, SIGA is likely to remain a beneficiary through the monkeypox epidemic.
SIGA Technologies is a commercial-stage company focused on the treatment of smallpox and other orthopoxvirus. Lead drug TPOXX was approved by the US FDA in 2018 for the treatment of smallpox and in the EU and UK under the broad label including all orthopox pathogens in 2022. In addition, three randomized, placebo-controlled trials were launched in October 2022 to assess the safety and efficacy of TPOXX in treating patients with monkeypox. The near-term outlook seems positive with upcoming BARDA contract-related deliveries for oral and IV TPOXX and upside optionality from additional/recurring government contracts.
With about 64k global cases and 23k cases in the United States, monkeypox remains a growing concern for governments and health agencies. SIGA’s antiviral product TPOXX is the leading therapeutic, originally designed to treat smallpox. In the United States, TPOXX was approved by the FDA for smallpox and is now available to treat monkeypox through the Centers for Disease Control and Prevention’s expanded access investigational new drug protocol. Currently, it is the only allowed therapy for all orthopoxvirus pathogens, including monkeypox, approved in both the UK (July 2022) and the EU (January 2022).