Welcome to our dedicated page for SIGA Technologies news (Ticker: SIGA), a resource for investors and traders seeking the latest updates and insights on SIGA Technologies stock.
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 (NASDAQ: SIGA) has secured a new $9 million contract with the U.S. Department of Defense for the procurement of TPOXX®, an antiviral medication. This marks the third DOD contract in three years for SIGA. The order primarily consists of oral TPOXX®, with a small amount of intravenous formulation included.
SIGA is also collaborating with the DOD's JPEO-CBRND on developing a Post-exposure Prophylaxis (PEP) indication for oral TPOXX®, supported by a $27 million development contract. With this new award, SIGA now has approximately $154 million in outstanding TPOXX® orders, with over 85% generated in the past three months.
SIGA Technologies announced topline results from the PALM 007 clinical trial of tecovirimat for mpox treatment. The study did not meet its primary endpoint of statistically significant improvement in lesion resolution time. However, meaningful improvements were observed in patients treated early (within 7 days of symptom onset) and those with severe disease (100+ skin lesions). Tecovirimat demonstrated a safety profile comparable to placebo. Despite missing the primary endpoint, SIGA remains encouraged by the potential benefits for specific patient groups. The company plans to analyze the data further and continue additional clinical trials to evaluate tecovirimat's efficacy in real-world settings.
SIGA Technologies (NASDAQ: SIGA) reported financial results for Q2 and H1 2024. Key highlights include:
- Q2 product sales of $20.7 million, including $18 million of IV TPOXX sales to the U.S. Government
- H1 product revenues of $44.6 million from diverse TPOXX deliveries
- Q2 net income of $1.8 million ($0.03 per diluted share)
- H1 net income of $12.1 million ($0.17 per diluted share)
- Received a $113 million procurement order for oral TPOXX from the U.S. Government in July
- Expanded international presence with new customers in ASEAN and Asia Pacific regions
- Special cash dividend of $0.60 per share paid in April
SIGA Technologies, Inc. (NASDAQ: SIGA), a commercial-stage pharmaceutical company, has announced a webcast and conference call scheduled for August 1, 2024, at 4:30 P.M. ET. The purpose of this event is to provide a business update following the release of the company's second-quarter 2024 financial results. CEO Diem Nguyen and CFO Daniel Luckshire will be participating in the call.
Investors and interested parties can access the live webcast on SIGA's website or dial in using the provided numbers. A replay of the call will be available for two weeks, and the archived webcast will be accessible in the Investor Relations section of the company's website.
SIGA Technologies (NASDAQ: SIGA) has announced a significant $113 million procurement order from the U.S. Department of Health and Human Services for oral TPOXX® treatment courses. This order, exercised under a current contract, aims to enhance orthopoxvirus preparedness. CEO Diem Nguyen highlighted that this order builds upon previous orders from the U.S. government and 15 international customers in 2023, supporting consistent action for public health protection against natural, accidental, or intentional threats. The project is supported by federal funds from various U.S. health agencies, including BARDA and the Strategic National Stockpile.
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.
FAQ
What is the current stock price of SIGA Technologies (SIGA)?
What is the market cap of SIGA Technologies (SIGA)?
What is SIGA Technologies Inc.?
What is TPOXX?
What recent regulatory approvals has TPOXX received?
What is the significance of the joint procurement mechanism in Europe for SIGA?
What is SIGA’s relationship with BARDA?
What pathogens does SIGA focus on?
How does SIGA contribute to global health security?
What financial performance is expected from SIGA in 2023?
How has SIGA expanded its international reach?
Where can I find more information about SIGA and its products?
