SIGA TECHNOLOGIES INC

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company that sells its lead product, TPOXX®, to the U.S. Government and international governments, including government-affiliated entities. In some international markets, the company may sell TPOXX® through a distributor. TPOXX® is an antiviral drug used to treat human smallpox disease caused by the variola virus. The company sells both an oral formulation and an intravenous formulation of TPOXX®. The oral formulation of TPOXX® was approved by the United States Food & Drug Administration (FDA) on July 13, 2018, for the treatment of smallpox. SIGA has been supplying oral TPOXX® to the U.S. Strategic National Stockpile since 2013. The intravenous formulation of TPOXX® was approved by the FDA on May 18, 2022, for the treatment of smallpox and is sold to the U.S. Government. Beyond FDA approval, oral TPOXX® (tecovirimat) has also received regulatory approval from the European Medicines Agency (EMA), Health Canada, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The EMA, MHRA, and PMDA approved oral TPOXX® for the treatment of smallpox, monkeypox (mpox), cowpox, and vaccinia complications following smallpox vaccination. Health Canada approved TPOXX® for the treatment of smallpox. The EMA and MHRA authorized TPOXX® under "exceptional circumstances" using the brand name Tecovirimat-SIGA, due to the rarity of smallpox and other orthopoxviruses, which limited the ability to gather complete efficacy and safety data through standard clinical studies. These authorizations require specific post-approval data collection and annual reassessments.