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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.
On May 5, 2022, SIGA Technologies reported significant progress with the first sale of intravenous TPOXX to the U.S. government under the 19C BARDA contract, generating $7 million in revenue. The company also secured a new contract in Asia Pacific for $3 million of oral TPOXX. Financially, total revenues reached $10.5 million in Q1 2022, compared to $4.8 million in Q1 2021. A special dividend of $0.45 per share has been declared, payable on June 2, 2022. Additionally, the company repurchased 1 million shares for $6.6 million, reflecting confidence in continued growth.
SIGA Technologies, Inc. (SIGA) has declared a special dividend of $0.45 per share on its common stock. This dividend will be payable on June 2, 2022, to shareholders recorded by the end of business on May 17, 2022. CEO Phil Gomez stated that this decision reflects the company's strong financial performance in 2020 and 2021, along with confidence in future prospects. SIGA specializes in countermeasures for health security, notably its lead product TPOXX, an antiviral for smallpox, with significant orders from the U.S. government amounting to approximately $705 million.
SIGA Technologies, Inc. (SIGA) announced a business update webcast scheduled for May 5, 2022, at 4:30 P.M. ET. The call will feature key executives including CEO Dr. Phil Gomez and CFO Daniel Luckshire. SIGA focuses on health security, with its primary product being TPOXX, an antiviral drug for smallpox, backed by approximately $705 million in U.S. government procurement. The oral formulation of TPOXX received FDA approval in 2018, while the EMA approved it in January 2022. More details are available on SIGA's website.
SIGA Technologies, Inc. (SIGA) reported robust financial results for 2021, achieving $133.7 million in total revenues, an increase from $89.1 million in 2020. The company delivered approximately $113 million of its oral TPOXX® to the U.S. government, amid significant supply chain challenges. International product sales rose to $13 million, compared to $2 million in 2020. SIGA also repurchased 3.8 million shares, representing about 5% of shares outstanding. With EMA approval for oral Tecovirimat in early 2022, SIGA is well-positioned for further growth.
SIGA Technologies, Inc. (SIGA) has initiated a clinical program to expand the FDA label for TPOXX® to include Post-Exposure Prophylaxis (PEP) for smallpox. The first study will compare immune responses to the Jynneos vaccine in participants receiving TPOXX. A second study aims to develop a safety dataset for extending TPOXX's dosing from 14 to 28 days. The research is supported by a $26 million R&D contract with the U.S. Department of Defense, highlighting concerns about smallpox as a potential bioweapon. TPOXX was previously approved for treating smallpox in July 2018.
SIGA Technologies, Inc. (SIGA) will host a webcast and conference call to provide a business update on March 3, 2022, at 4:30 PM ET. Participating will be CEO Dr. Phil Gomez and CFO Daniel Luckshire. The call can be accessed via a dedicated phone line or through a live webcast available on the company’s website. SIGA focuses on the health security market, with its lead product TPOXX® approved for treating human smallpox and various pox diseases. The company highlights the importance of TPOXX in biodefense and preparedness.
SIGA Technologies has announced a collaboration with Bioarchitech to investigate the use of TPOXX® (tecovirimat) combined with Bioarchitech's oncolytic vaccinia immunotherapy platform. This partnership aims to enhance the efficacy of cancer treatments by utilizing TPOXX to allow for higher doses of vaccinia vectors, potentially improving patient outcomes. TPOXX has FDA approval for smallpox treatment and has shown effectiveness against various orthopoxviruses. This collaboration reflects SIGA's commitment to advancing health security through innovative therapies.
SIGA Technologies (SIGA) announced its participation in the Edison Group’s Global Healthcare Open House Conference on January 25-27, 2022. CEO Phil Gomez will present and be available for 1x1 meetings. The company presentation will be available on demand starting January 26 at 7am ET on edison.com. This follows SIGA's recent FDA and EMA approvals for its lead product, TPOXX, an antiviral for smallpox and related diseases. For registration details, visit SIGA's investor page.
SIGA Technologies, Inc. (SIGA) has received European Medicines Agency (EMA) approval for oral tecovirimat, the same formulation previously approved by the U.S. FDA. The approval allows SIGA to market tecovirimat for treating smallpox, monkeypox, cowpox, and vaccinia complications in the EU, Norway, Iceland, and Liechtenstein. This regulatory milestone supports SIGA's commitment to health security and preparedness against biological threats. The company aims to enhance global access to this critical antiviral medication while maintaining its intellectual property rights.
SIGA Technologies, Inc. (SIGA) announced that Health Canada has approved oral TPOXX® (tecovirimat) for treating human smallpox in adults and children over 13 kg. This approval marks a significant milestone, facilitated by support from the Canadian Department of National Defence, ensuring the continued supply for stockpiling as a key countermeasure. SIGA's TPOXX is a vital antiviral drug that was previously FDA-approved in July 2018. The partnership with Meridian Medical Technologies will promote international sales of TPOXX outside the U.S.
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