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SIGA Technologies Inc. (NASDAQ: SIGA) is a commercial-stage pharmaceutical company that targets the health security market. SIGA specializes in the development of antiviral therapeutics aimed at treating some of the world's most lethal pathogens including smallpox, Ebola, dengue, and Lassa fever. The company's flagship product, TPOXX® (also known as tecovirimat and ST-246®), is an oral and intravenous formulation antiviral drug approved for the treatment of human smallpox disease caused by the variola virus.
TPOXX has received approval from multiple regulatory bodies. In 2018, the U.S. Food and Drug Administration (FDA) approved the oral formulation of TPOXX, followed by approval for the intravenous formulation in 2022. The European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom also approved oral TPOXX in 2022 for treating smallpox, monkeypox, cowpox, and complications arising from vaccinia virus infections post smallpox vaccination.
In recent developments, SIGA has expanded its reach in Europe through a joint procurement mechanism, allowing multiple EU countries to access oral TPOXX. Orders under this mechanism are anticipated to generate around $164 million in 2023, with a substantial portion of deliveries expected within the year. As such, the company projects a pre-tax operating income between $90 million and $100 million for 2023. Additionally, SIGA has recently amended its international promotion agreement with Meridian Medical Technologies, Inc., granting SIGA primary responsibility for promoting oral TPOXX in various territories, including the European Union, thereby enhancing its global reach.
SIGA also maintains a strong relationship with the Biomedical Advanced Research and Development Authority (BARDA) for the procurement and development of both oral and intravenous formulations of TPOXX under Project BioShield. This partnership underscores SIGA's commitment to enhancing global health security through its innovative antiviral treatments.
With a clear focus on health security, SIGA aims to address high-priority biological threats, providing solutions that are crucial in preparing for and mitigating the impact of infectious diseases and potential bioterrorist threats.
SIGA Technologies has announced an agreement to sell its antiviral drug TPOXX (tecovirimat) to ASEAN member states. The agreement was signed by the Ministry of Health of Brunei Darussalam on behalf of ASEAN, reflecting a collective effort to prepare for public health events such as Mpox and smallpox. This collaboration with Meridian Medical Technologies aims to ensure an adequate supply of TPOXX in the region, which comprises over 600 million people with a GDP of $3.6 trillion. Financial details of the agreement were not disclosed.
Calidi Biotherapeutics has partnered with SIGA Technologies to advance its RTNova virotherapy for lung cancer and metastatic solid tumors. RTNova leverages a vaccinia virus enveloped by a human cell membrane to evade immunity and enhance therapeutic functions. SIGA will supply TPOXX, an antiviral agent against vaccinia virus, to support RTNova's development. This collaboration aims to create a universal treatment for all tumor types and will initially focus on lung cancer and metastatic solid tumors. RTNova's novel approach allows for easy administration and a broader patient reach. The partnership offers a safety mechanism for clinical trials, ensuring better regulatory compliance and patient safety.
SIGA Technologies, Inc. reported strong financial results for Q1 2024, with $24 million in product sales and $11 million in pre-tax operating income, showcasing growth over the previous year. The company highlighted focus on financial and operational excellence, TPOXX® franchise value, and team resilience. Recent developments include a new drug application in Japan and an amendment with Meridian Medical Technologies. SIGA also delivered $24 million of oral TPOXX in Q1, with a special cash dividend of $0.60 per share declared. The conference call and webcast to provide a business update are scheduled for May 7, 2024.
SIGA Technologies, a pharmaceutical company, will host a business update call on May 7, 2024, following the release of their first-quarter financial results. The call will feature the CEO and CFO and will be available via webcast and conference call. Participants can access the call through the company's website or by dialing in. A replay will be available for two weeks.
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