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, Inc. (SIGA) announced approximately $16 million in international procurement orders for oral TPOXX® (tecovirimat) in August and early September 2022. This includes a $10 million order from the European Commission for emergency stockpiling related to the monkeypox outbreak, funded by HERA. Additionally, two orders totaling $6 million were received from the Asia Pacific region. SIGA expects to deliver at least $65 million of orders in 2022, contributing to addressing the ongoing monkeypox crisis.
SIGA Technologies, Inc. (SIGA) announced the exercise of procurement options with the U.S. Department of Health and Human Services for intravenous (IV) TPOXX treatment courses valued at approximately $26 million. This marks the first procurement exercise under the 19C contract. Product deliveries are targeted for 2023. CEO Phil Gomez emphasized the importance of IV TPOXX for those unable to swallow and the ongoing cooperation with the U.S. government for further procurements. The procurement also includes manufacturing bulk drug substance for IV TPOXX.
SIGA Technologies reported a strong second quarter with approximately $9 million in product sales, including the first sale of oral TPOXX to the U.S. Department of Defense and around $5 million in international sales. Year-to-date, SIGA has secured $60 million in international orders from ten jurisdictions, highlighting a growing demand for its products due to health security concerns. The company also paid a special dividend of $0.45 per share and repurchased shares worth $3.6 million. The reported revenues for Q2 2022 were $16.7 million, significantly up from $8.7 million in Q2 2021.
SIGA Technologies, Inc. (SIGA) has announced a business update conference call scheduled for August 4, 2022, at 4:30 P.M. ET. The call will feature key management including CEO Dr. Phil Gomez and CFO Daniel Luckshire. Participants can join via phone or access a live webcast on SIGA's website. SIGA focuses on health security, with its lead product TPOXX® approved for smallpox treatment and recently endorsed by the European Medicines Agency for additional uses. The company is under contract with BARDA for further development of TPOXX.
SIGA Technologies, Inc. (SIGA) announced a collaboration with KaliVir Immunotherapeutics to provide TPOXX® for their oncolytic vaccinia immunotherapy program. TPOXX, approved by the FDA for smallpox treatment, will support KaliVir's innovative virus platform designed for cancer therapy. Dr. Phil Gomez, SIGA's CEO, expressed enthusiasm for the partnership, emphasizing TPOXX's potential to enhance immunotherapeutic outcomes. KaliVir aims to pair oncolytic therapies with antiviral agents to improve treatment efficacy. This collaboration marks a significant step in advancing cancer immunotherapies.
SIGA Technologies (SIGA) announced approximately $28 million in procurement orders for oral TPOXX (tecovirimat), including $26 million from Canada and $2 million from two new international jurisdictions. The Public Health Agency of Canada (PHAC) ordered $39 million this year, including an increase of $9 million to an existing contract. Overall, SIGA has received $56 million in international orders from six jurisdictions in 2022, highlighting a strong public health reaction to the evolving monkeypox outbreak.
SIGA Technologies, Inc. announced the approval of tecovirimat (oral TPOXX) by the United Kingdom for treating smallpox, monkeypox, cowpox, and vaccinia complications in adults and children over 13kg. This approval enhances health emergency preparedness amid ongoing monkeypox outbreaks. Tecovirimat was previously approved by the FDA in 2018 and by Health Canada in 2021. The company emphasizes the importance of building stockpiles for infectious disease outbreaks and potential bioterror threats.
SIGA Technologies, Inc. (SIGA) announced about $13 million in procurement orders for its antiviral drug, oral TPOXX (tecovirimat). This includes $11 million for initial orders from two new international jurisdictions and $2 million from a country in the Asia Pacific region under an existing contract. The orders are driven by increased inquiries related to the global monkeypox outbreak, with SIGA expected to deliver approximately $4 million within 45 days and the remaining $7 million in 2023. The FDA approved oral TPOXX in 2018 to treat smallpox, highlighting its relevance amidst recent health threats.
SIGA Technologies (SIGA) announced its CEO Phil Gomez and CSO Dennis Hruby will join a panel on June 23, 2022, at 12 PM ET to discuss monkeypox outbreaks in the U.K., EU, and U.S. The event, hosted by Alliance Global Partners, will feature representatives from Emergent Biosolutions and Tonix Pharmaceuticals.
SIGA's lead product, tecovirimat (TPOXX), was approved by the EMA in January 2022 for treating smallpox and monkeypox. Although authorized for smallpox in the U.S., it is not FDA-approved for monkeypox treatment.
SIGA Technologies (SIGA) has received FDA approval for the intravenous (IV) formulation of TPOXX to treat smallpox. This approval allows broader access for patients who cannot take oral medications. The oral formulation is already approved in the US, Canada, and Europe. TPOXX is recognized for its role in U.S. preparedness against biological threats, including smallpox and monkeypox. SIGA remains committed to enhancing public health security through effective countermeasures.
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?
