SIGA Technologies - IV TPOXX receives FDA Approval
SIGA Technologies announced the FDA approval for its intravenous (IV) formulation of tecovirimat (TPOXX), an antiviral drug for the treatment of smallpox. We had already anticipated that approval was very likely to occur, and the formal decision expands the company’s addressable market to those who are unable to take the oral formulation (which was approved by the FDA in 2018). This follows on the heels of strong Q122 results and recent milestones, including EMA approval for oral TPOXX, the first contract for TPOXX in the Asia-Pacific region and increases in the Canadian oral TPOXX contract. We expect this new delivery medium, international expansion and the ongoing clinical study (on post-exposure prophylactic, PEP) to remain the key upcoming catalysts for SIGA shares. We maintain our $666m ($9.17 per share) equity valuation.SIGA Technologies is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness. The company's primary product is an oral formulation of TPOXX?, an antiviral drug for the treatment of human smallpox disease caused by variola virus. The United States Food and Drug Administration has approved oral TPOXX? for the treatment of smallpox.
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