SIGA Technologies
An American biopharmaceutical company developing and supplying antiviral countermeasures for orthopoxvirus and other infectious-disease threats.
Last updated August 25, 2026
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Overview
SIGA Technologies, Inc. is an American biopharmaceutical company headquartered in New York City. Established in 1995, it develops and supplies medicines intended to address infectious diseases and biological threats, with its business centered on antiviral countermeasures that can be procured by governments, public-health agencies, and defense organizations. The company is best known for tecovirimat, marketed as TPOXX, an antiviral treatment developed for smallpox and related orthopoxvirus infections. TPOXX became the foundation of SIGA’s commercial and public-sector strategy. The drug was developed in the context of preparedness for smallpox, a disease eradicated in naturally occurring human transmission but retained as a major biodefense concern. Its potential applications also extend to monkeypox, cowpox, and complications associated with vaccinia virus. SIGA’s work has therefore been closely connected with the United States Biomedical Advanced Research and Development Authority, the Strategic National Stockpile, the Department of Defense, and other government institutions responsible for preparing for biological emergencies. The company’s development history includes federally supported research into broad-spectrum antivirals and treatments for arenavirus diseases such as Lassa fever. In 2011, SIGA entered into a large procurement and development arrangement with BARDA for TPOXX. It subsequently delivered hundreds of thousands of treatment courses to the United States Strategic National Stockpile. The company also faced a major legal dispute with PharmAthene over rights and contractual obligations relating to tecovirimat. The dispute resulted in a substantial damages award and contributed to SIGA’s Chapter 11 bankruptcy filing in 2014, although the company continued its product-development and government-supply activities. TPOXX received important regulatory milestones during the late 2010s and early 2020s. The United States Food and Drug Administration approved the oral formulation in 2018 after an advisory committee concluded that its benefits outweighed its potential risks. SIGA later developed an intravenous formulation, which the FDA approved in 2022. Oral tecovirimat also received authorization in Canada and the European Union for specified orthopoxvirus indications. During the 2022 mpox outbreak, United States regulatory and public-health authorities made access to TPOXX easier for appropriate patients, increasing public attention to the product. SIGA’s business remains concentrated rather than diversified across a broad consumer pharmaceutical portfolio. Its principal offering is TPOXX in oral and intravenous forms, supported by manufacturing, regulatory, distribution, and government-contracting capabilities. The company’s positioning is that of a specialist developer and supplier of medical countermeasures for high-consequence infectious diseases, especially where conventional commercial demand may be limited but preparedness requirements are significant. Because procurement is closely tied to government stockpiling and emergency-response programs, SIGA’s commercial prospects are influenced by public-health policy, biodefense budgets, regulatory decisions, outbreak conditions, and the renewal or expansion of supply contracts.
History
SIGA Technologies was founded in 1995 in the United States and developed as a specialist biopharmaceutical company working on treatments for infectious diseases and biological threats. Rather than building a broad portfolio of mass-market medicines, SIGA concentrated on countermeasures whose principal customers could include government agencies preparing for rare but severe public-health emergencies. This model placed research, regulatory strategy, manufacturing, and public procurement at the center of the company’s development. During the late 2000s, SIGA pursued antiviral research supported by federal funding. In 2009, the National Institutes of Health awarded the company research funding for broad-spectrum antiviral candidates. In 2011, the NIH provided a further grant for development of an antiviral intended to treat Lassa fever and other arenavirus infections. These programs reflected SIGA’s wider interest in pathogens for which conventional commercial incentives may be limited but national preparedness needs are substantial. The company’s most consequential program became tecovirimat, later marketed as TPOXX. Tecovirimat was developed as a treatment for orthopoxvirus infections, particularly smallpox, and was also relevant to monkeypox, cowpox, and vaccinia complications. In 2011, SIGA concluded an arrangement valued at more than $400 million with the United States Biomedical Advanced Research and Development Authority for development and distribution of the antiviral. The relationship connected SIGA to the federal medical-countermeasure system and the Strategic National Stockpile. SIGA’s progress was accompanied by a prolonged dispute with PharmAthene involving rights and contractual obligations connected with tecovirimat. A damages award of $232 million was reported in 2011. The litigation created severe financial pressure, and in 2014 SIGA filed for Chapter 11 bankruptcy protection in an effort to address the consequences of the dispute and avoid paying a court bond. The company nevertheless continued its government-oriented product work. In 2013, it delivered about 590,000 courses of tecovirimat to the Strategic National Stockpile. Regulatory progress strengthened the product’s position. In 2018, an FDA advisory committee concluded that TPOXX’s benefits outweighed its potential risks, and the FDA subsequently approved the oral formulation for smallpox treatment. SIGA later expanded the program through post-exposure prophylaxis development supported by a 2019 Department of Defense contract. The company also submitted an intravenous version to the FDA. That formulation was approved in May 2022, providing an alternative for situations in which oral administration is unsuitable. Intravenous use has particular relevance to patients who cannot meet the oral formulation’s pediatric weight threshold, subject to applicable regulatory arrangements. International recognition followed. Health Canada approved oral TPOXX for specified smallpox uses in 2021. In January 2022, the European Union authorized oral tecovirimat for smallpox, monkeypox, cowpox, and vaccinia complications in adults and children weighing at least 13 kilograms. The global mpox outbreak in 2022 brought the product and SIGA’s public-health role to wider attention. United States agencies adjusted access arrangements to help clinicians prescribe or obtain TPOXX for appropriate mpox patients. Today, SIGA remains primarily identified with TPOXX and with the government medical-countermeasure market. Its operating model depends on maintaining regulatory approvals, supplying stockpiles, developing additional formulations or indications, and working with agencies responsible for biodefense and outbreak response. The company’s history illustrates the opportunities and risks of a specialized pharmaceutical business whose demand is strongly shaped by public procurement, emergency preparedness, litigation, and infectious-disease events.
- 2022
European Union authorization and FDA intravenous approval
[1]Oral tecovirimat receives European Union authorization for specified orthopoxvirus indications, while the FDA approves intravenous TPOXX in the United States.
- 2021
Health Canada approves oral TPOXX
[1]Health Canada authorizes oral TPOXX for specified smallpox treatment use.
- 2019
Department of Defense prophylaxis contract
[1]SIGA signs a contract with the Department of Defense to develop TPOXX post-exposure prophylaxis.
- 2018
FDA approves oral TPOXX
[1]The FDA approves oral tecovirimat for smallpox treatment after a favorable advisory-committee assessment.
- 2014
Chapter 11 filing
[1]The company files for Chapter 11 protection amid the financial consequences of its PharmAthene litigation.
- 2013
Strategic National Stockpile delivery
[1]SIGA delivers approximately 590,000 tecovirimat courses to the United States Strategic National Stockpile.
- 2011
Arenavirus research grant and BARDA arrangement
[1]SIGA receives NIH support for Lassa fever-related research and enters a major United States government arrangement for TPOXX.
- 2009
NIH funds broad-spectrum antiviral research
[1]The company receives NIH research support for broad-spectrum antiviral candidates.
- 1995
SIGA Technologies is founded
[1]SIGA Technologies is established in the United States as a biopharmaceutical company focused on infectious-disease solutions.
Products and positioning
A specialist biopharmaceutical and medical-countermeasure company focused on antiviral treatments for high-consequence infectious diseases and public-health emergencies.
Antiviral medical countermeasure · 2018
TPOXX (tecovirimat)
TPOXX is SIGA’s principal product and is intended to treat orthopoxvirus infections, particularly smallpox. Its relevance also includes monkeypox, cowpox, and complications associated with vaccinia virus, subject to the indication and authorization applicable in each market. The product is available in oral and intravenous forms. It was developed for both clinical use and government stockpiling, making it central to national biodefense and outbreak-response programs.
Oral antiviral · 2018
Oral tecovirimat
The oral formulation of tecovirimat is marketed as TPOXX and was approved by the United States FDA in 2018 for smallpox treatment in adults and children. It was later authorized in Canada and the European Union for specified indications. In the United States, access was expanded during the 2022 mpox response through public-health and regulatory arrangements.
Intravenous antiviral · 2022
Intravenous TPOXX
Intravenous tecovirimat is an alternative administration form for patients for whom oral treatment is unsuitable. The FDA approved it in 2022. It has no lower weight cap in the same manner as the oral formulation and may be used in infants under an Investigational New Drug protocol, subject to applicable requirements.
Controversies
2011
PharmAthene contract and tecovirimat litigation
SIGA became involved in a major legal dispute with PharmAthene concerning rights and contractual issues related to tecovirimat. A substantial damages award was reported against SIGA, and the dispute contributed to the company’s later Chapter 11 filing.
Brand decisions
2022
Add an intravenous TPOXX formulationGeneration changeBackground
Some patients may be unable to take or absorb an oral antiviral, creating a need for an alternative route of administration.
Action taken
SIGA submitted an intravenous formulation to the FDA and received approval in May 2022.
Aftermath
The additional formulation broadened the clinical utility of the TPOXX program, including potential use for very young patients under applicable protocols.
2018
Obtain FDA approval for oral TPOXXProduct launchBackground
The company sought regulatory approval for an antiviral intended for smallpox, a rare but high-consequence disease for which government preparedness is important.
Action taken
Following a favorable FDA advisory-committee assessment, SIGA obtained approval for oral TPOXX.
Aftermath
The approval established TPOXX as the company’s principal regulated product in the United States.
2014
Seek Chapter 11 bankruptcy protectionOtherBackground
SIGA faced financial pressure after losing a contract dispute and being required to address an associated court bond obligation.
Action taken
The company filed for Chapter 11 bankruptcy protection.
Aftermath
SIGA continued developing and supplying tecovirimat while addressing the consequences of the litigation through the bankruptcy process.
2011
Enter a BARDA procurement and development arrangementOtherBackground
SIGA needed a public-sector development and distribution framework for its orthopoxvirus antiviral, whose principal market was government preparedness rather than routine consumer demand.
Action taken
The company entered an arrangement with the United States Biomedical Advanced Research and Development Authority for TPOXX development and supply.
Aftermath
The arrangement connected SIGA with federal stockpiling and biodefense procurement and became a foundation of the company’s commercial strategy.
Reported contract value. More than $400 million (2011)
Recent events
SIGA reports 2021 financial results[3]
SIGA Technologies reported financial results for the three and twelve months ended December 31, 2021, including approximately $133.7 million in total revenue for the year.
Reported
Cipla and SIGA announce strategic partnership[4]
Cipla and SIGA Technologies announced a strategic partnership to deliver sustained innovation and access to novel antibacterial drugs, particularly against biothreats.
Sources4 sources
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