SIGA Technologies (NASDAQ:SIGA) Stock

SIGA Technologies

SIGA Technologies Inc is a commercial-stage pharmaceutical company focused on the health security market. The company's main product is TPOXX, an oral formulation antiviral drug for the treatment of human smallpox disease caused by the variola virus. The company derives maximum revenue from United States.

SIGA Technologies Inc

SIGA Technologies&#8217; (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) antiviral drug tecovirimat, when used without other treatments, did not reduce the time for clade II mpox lesions to heal or significantly alleviate pain, according to results from an international clinical trial sponsored by the <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">National Institutes of Health (NIH)</a>.
The study, known as STOMP, was halted in late 2024 after an interim analysis indicated the drug was ineffective in the study population.
Mpox has two <a target="_blank" href="https://www.niaid.nih.gov/news-events/tecovirimat-safe-ineffective-treatment-clade-ii-mpox" rel="noreferrer noopener">identified</a> variants: clades I and II. A clade II outbreak in 2022 led to global transmission, with continued low-level circulation.
Meanwhile, a clade I outbreak in Central and East Africa was declared a public health emergency in 2024.
STOMP launched in September 2022 as part of a U.S. government initiative addressing the clade II mpox outbreak.
No mpox-specific treatments have been approved in the U.S.
Tecovirimat, also known as TPOXX, was originally authorized by the FDA to treat smallpox based on animal studies but had not been evaluated in humans with mpox before STOMP and a parallel study, PALM007, conducted in the Democratic Republic of the Congo.
PALM007 yielded similar results from STOMP, further questioning tecovirimat's effectiveness for mpox.
Results showed that by day 29, 83% of participants taking tecovirimat had achieved clinical resolution, compared to 84% in the placebo group, indicating no meaningful difference.
Among those who reported severe pain at the study's outset, pain reduction was similar across groups, with tecovirimat users reporting an average decrease of 3.2 points on an 11-point scale, compared to 3.1 points for placebo recipients.
Viral DNA levels declined over time in both groups, with no statistically significant differences at key checkpoints.
Adverse event rates were also comparable between treatment and placebo groups.
A separate exploratory analysis examined STOMP's open-label participants—those at higher risk of severe mpox. The analysis found that younger participants and those without HIV or with well-controlled HIV experienced faster lesion resolution. 
However, no strong correlation was observed between symptom duration before study entry and recovery speed. Researchers noted that open-label participants had fewer lesions but slower recovery compared to PALM007 trial participants.
On Tuesday, SIGA Technologies reported <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44262141/siga-reports-financial-results-for-three-and-twelve-months-ended-december-31-2024" rel="noreferrer noopener">fourth-quarter earnings</a> of 63 cents, down from $1.01, and sales of $81.4 million, down $116.5 million <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">from a year ago</a>.
Price Action: SIGA stock is up 7.05% at $6.02 at the last check Wednesday.
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Biotech

News

Health Care

General

SIGA

NIH Trial Finds Tecovirimat Ineffective As Monotherapy For Mpox

<a href="https://www.niaid.nih.gov/news-events/tecovirimat-safe-ineffective-treatment-clade-ii-mpox">https://www.niaid.nih.gov/news-events/tecovirimat-safe-ineffective-treatment-clade-ii-mpox</a>
The antiviral drug tecovirimat used without other antivirals did not reduce the time to clinical resolution of clade II mpox lesions or improve pain control among adults in an international clinical trial sponsored by the National Institutes of Health (NIH). The&nbsp;<a href="https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain">trial enrollment was stopped in late 2024</a> when an interim analysis showed that tecovirimat monotherapy was ineffective in the study population. Detailed results were presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.

'Tecovirimat Is Safe But Ineffective As Treatment For Clade II Mpox' - NIH

Guidance

SIGA Says It Remains Focused On Durable Growth And Impact As It Enters 2025, Supported By $70M Of Outstanding Procurement Orders

SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) reported quarterly earnings of $0.63 per share. This is a 37.62 percent decrease over earnings of $1.01 per share from the same period last year. The company reported $81.40 million in sales this quarter. This is a 30.13 percent decrease over sales of $116.50 million the same period last year.

Earnings

SIGA Technologies Q4 2024 GAAP EPS $0.63 Down From $1.01 YoY, Sales $81.40M Down From $116.50M YoY

<h3>Companies Reporting Before The Bell</h3>
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• Champions Oncology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CSBR#NASDAQ">CSBR</a>) is projected to report quarterly loss at $0.01 per share on revenue of $12.93 million. 
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• SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) is likely to report earnings for its fourth quarter. 
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Earnings Scheduled For March 11, 2025

On Thursday,&nbsp;the Japan Ministry of Health, Labour and Welfare approved SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) antiviral treatment TEPOXX (tecovirimat 200 mg capsules) for smallpox, mpox, cowpox, as well as complications following smallpox vaccination in adults and pediatric patients <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42761893/tepoxx-tecovirimat-approved-in-japan-for-the-treatment-of-orthopoxviruses" rel="noreferrer noopener">weighing at least 13 kg</a>.
TEPOXX is the first antiviral therapy for orthopoxviruses approved by Japan's drug regulator in collaboration with the Ministry of Health, Labour, and Welfare.&nbsp;&nbsp;
In partnership with Japan Biotechno Pharma, SIGA's exclusive distributor in Japan, SIGA has delivered an order of TEPOXX to help build Japan's strategic national stockpile.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40394363/in-nih-cosponsored-monkeypox-virus-study-in-congo-siga-technologies-antiviral-tecovirimat-did-not" rel="noreferrer noopener">In NIH-Cosponsored Mpox Virus Study In Congo, SIGA Technologies' Antiviral Tecovirimat Did Not Improve Lesion Resolution, Stock Tanks</a>
The Japanese approval is based on data from 15 clinical trials of oral TEPOXX in over 800 healthy volunteers, including a pivotal repeat-dose phase 1 pharmacokinetics (PK) trial involving 20 healthy volunteers conducted in Japan.
These studies showed no drug-related serious adverse events and quantifiable PK within efficacious dose ranges. Four pivotal studies in non-human primates (NHPs) and two pivotal studies in rabbits demonstrated that TEPOXX significantly reduced mortality and viral load.
TEPOXX is a highly targeted small-molecule antiviral that inhibits the VP37 protein found on the surface of all orthopoxviruses. By preventing the virus from exiting infected cells, TEPOXX slows the spread of the infection, enabling the immune system to clear the virus.
TPOXX is approved for smallpox in the U.S.&nbsp;and Canada. In the&nbsp;European Union and the UK, marketed as Tecovirimat-SIGA, it is approved&nbsp;for smallpox, mpox, and cowpox and to treat complications following smallpox vaccination.
Earlier this year, the National Institutes of Health's National Institute of Allergy and Infectious Diseases announced topline results from a preliminary analysis of the PALM 007 trial of<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40394363/in-nih-cosponsored-monkeypox-virus-study-in-congo-siga-technologies-antiviral-tecovirimat-did-not" rel="noreferrer noopener"> tecovirimat for mpox</a>.
The study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with mpox who were administered SIGA's tecovirimat versus placebo, weighing <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534370/government-contract-win-may-improve-investor-sentiment-for-siga-tech-after-disappointing-trial-da" rel="noreferrer noopener">on the share price</a>.
Price Action: At last check Thursday, SIGA stock was up 3.01% at $6.19.
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Movers

Japan Approves SIGA Technologies Antiviral As First For Smallpox, Mpox

WIIM

SIGA Technologies shares are trading higher after the company announced TEPOXX was approved in Japan for the treatment of orthopoxviruses.

Regulatory decision marks first approval in Japan of an antiviral for the treatment of orthopoxviruses including smallpox, mpox and cowpox.
Japan&nbsp;Biotechno Pharma Co., Ltd. engaged as exclusive distributor to supply TEPOXX to Japan's national stockpile. &nbsp;

SIGA Technologies Says TEPOXX (Tecovirimat 200 Mg Capsules) Has Received Regulatory Approval In Japan

U.S. stock futures were mixed this morning, with the Dow futures falling around 0.2% on Monday.
Shares of Arm Holdings plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARM#NASDAQ">ARM</a>) fell sharply in today's pre-market trading after a US jury reportedly found Qualcomm (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QCOM#NASDAQ">QCOM</a>) did not breach Nuvia&#8217;s license agreement <a href="https://www.benzinga.com/quote/ARM">with the company</a>.
Arm Holdings shares fell 2.3% to $129.14 in the pre-market trading session.
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<li>Core Laboratories Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLB#NYSE">CLB</a>) shares dipped 11% to $15.00 in pre-market trading.</li>
<li>Astria Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATXS#NASDAQ">ATXS</a>) shares declined 10.8% to $8.53 in pre-market trading.</li>
<li>SIGA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) declined 8.5% to $5.41 in pre-market trading.</li>
<li>Dnow Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DNOW#NYSE">DNOW</a>) fell 7.7% to $11.90 in pre-market trading.</li>
<li>DiamondRock Hospitality Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DRH#NYSE">DRH</a>) fell 4.3% to $8.92 in pre-market trading.</li>
<li>NI Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NODK#NASDAQ">NODK</a>) fell 3.8% to $14.73 in pre-market trading.</li>
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Pre-Market Outlook

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Arm Holdings And Other Big Stocks Moving Lower In Monday's Pre-Market Session

Shares of Rumble Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RUM#NASDAQ">RUM</a>) rose sharply in today's pre-market trading after the company announced it has entered into a definitive agreement for a strategic <a href="https://www.benzinga.com/24/12/42634166/rumble-stock-soars-on-775-million-investment-from-tether-what-to-know">investment of $775 million from Tether</a>.
Tether (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/">USDT</a>) has agreed to purchase 103.33 million shares of Rumble Class A Common Stock at a price per share of $7.50, totaling $775 million in gross proceeds to Rumble.
Rumble shares jumped 43.3% to $10.31 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Reliance Global Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RELI#NASDAQ">RELI</a>) gained 234% to $4.01 in pre-market trading.</li>
<li>Phio Pharmaceuticals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) gained 88.6% to $3.32 in pre-market trading. Phio Pharmaceuticals, last week, announced a $1.15 million registered direct offering priced at-the-market under Nasdaq rules.</li>
<li>Edible Garden AG Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EDBL#NASDAQ">EDBL</a>) climbed 82.3% to $0.4334 in pre-market trading after surging 63% on Friday. Edible Garden recently announced it experienced a 51% year-over-year increase in its preliminary Thanksgiving period sales.</li>
<li>JIADE Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JDZG#NASDAQ">JDZG</a>) gained 60.9% to $0.8530 in pre-market trading. JIADE received Nasdaq notification letter regarding minimum bid price deficiency.</li>
<li>American Battery Technology Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABAT#NASDAQ">ABAT</a>) rose 44.1% to $1.60 in pre-market trading. On Friday, American Battery Technology priced its $5 million registered direct offering of 5 million shares at $1.00 per share.</li>
<li>SEALSQ Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LAES#NASDAQ">LAES</a>) gained 30.9% to $3.60 in pre-market trading after jumping more than 36% on Friday.</li>
<li>Brenmiller Energy Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNRG#NASDAQ">BNRG</a>) rose 28.8% to $0.9700 in pre-market trading after the company was awarded ISO/IEC 27001:2022 certification.</li>
<li>Honda Motor Co., Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HMC#NYSE">HMC</a>) gained 18% to $28.19 in pre-market trading. Honda Motor and Nissan Motor Co. Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NSANY#OTC">NSANY</a>) have started talks for a potential merger.</li>
<li>Kodiak Sciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KOD#NASDAQ">KOD</a>) rose 14.9% to $9.94 in pre-market trading.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Conduit Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDT#NASDAQ">CDT</a>) shares tumbled 28.9% to $0.0531 in pre-market trading after jumping 14% on Friday. Conduit Pharmaceuticals recently announced it entered an agreement with Sarborg to leverage AI and its cybernetics platform to evaluate key deliverables across multiple areas of operations.</li>
<li>Helius Medical Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSDT#NASDAQ">HSDT</a>) declined 25.7% to $0.6759 in pre-market trading after jumping around 101% on Friday.</li>
<li>Onfolio Holdings, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONFO#NASDAQ">ONFO</a>) fell 24.4% to $1.21 in pre-market trading. Onfolio Holdings announced a quarterly preferred stock cash dividend of 75 cents per share.</li>
<li>iLearningEngines, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AILE#NASDAQ">AILE</a>) shares fell 24.3% to $0.6703 in pre-market trading after declining 9% on Friday.</li>
<li>ConnectM Technology Solutions Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNTM#NASDAQ">CNTM</a>) shares dipped 20% to $0.83 in pre-market trading after falling 8% on Friday. ConnectM Technology Solutions, last week, announced a year-over-year increase in third-quarter revenue results.</li>
<li>TPI Composites, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPIC#NASDAQ">TPIC</a>) fell 19.2% to $1.94 in today's pre-market trading after jumping 97% on Friday.</li>
<li>Aptose Biosciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APTO#NASDAQ">APTO</a>) dipped 17.8% to $0.2293 in pre-market trading after jumping 64% on Friday. Aptose Biosciences, last week, announced it was granted an extension to provide compliance evidence for a continued Nasdaq listing.</li>
<li>Core Laboratories Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLB#NYSE">CLB</a>) fell 11% to $15.00 in pre-market trading.</li>
<li>Astria Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATXS#NASDAQ">ATXS</a>) shares fell 10.8% to $8.53 in pre-market trading.</li>
<li>SIGA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) fell 8.5% to $5.41 in pre-market trading.</li>
</ul>
Now Read This: &lt;a href=&#8221;https://www.benzinga.com/news/earnings/24/04/38307448/investor-sentiment-decreases-further-s-p-500-falls-for-fourth-straight-session&#8221;&gt;&lt;em&gt; Investor Sentiment Decreases Further, S&amp;P 500 Falls For Fourth Straight Session&lt;/em&gt;&lt;/a&gt;

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Why Rumble Shares Are Trading Higher By Around 43%; Here Are 20 Stocks Moving Premarket

SIGA Technologies shares are trading lower after interim results from the STOMP study showed that Tecovirimat did not improve the time to lesion resolution compared to placebo in adults with mild to moderate clade II Mpox.

<a href="https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain">https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain</a>
<h2>Study Examined Tecovirimat in Countries Affected by Global Clade II Mpox Outbreak</h2>
&nbsp;
The antiviral drug tecovirimat did not reduce the time to lesion resolution&nbsp;or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat.&nbsp;
Considering&nbsp;these definitive findings, the study's Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB's recommendation.&nbsp;Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug's efficacy.&nbsp;

'NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution Or Pain'

SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) reported quarterly earnings of $0.02 per share. This is a 300 percent increase over losses of $(0.01) per share from the same period last year. The company reported $10.00 million in sales this quarter. This is a 8.28 percent increase over sales of $9.23 million the same period last year.

SIGA Technologies Q3 EPS $0.02 Up From $(0.01) YoY, Sales $10.00M Up From $9.23M YoY

SIGA Enters Exclusive License Agreement With Vanderbilt University To Obtain A License To A Portfolio Of Preclinical Fully Human Poxvirus Monoclonal Antibodies

The contract was executed in response to a request from the Ministry of Health in Morocco to make the therapy available in the country and help prepare and protect its citizens against any potential mpox outbreak.
Tecovirimat is approved in the U.S., Canada, and the EU, and while it has also been available in Africa through clinical trials and as part of the World Health Organization&#39;s emergency use access protocol, this agreement marks SIGA&#39;s first commercial sale of TPOXX on the continent.

Contracts

SIGA Technologies Enters Agreement To Supply TPOXX (Tecovirimat) In Morocco

The World Health Organization announced a new strategic preparedness and response plan Monday in the fight against mpox, two weeks after declaring a public health emergency<a href="https://www.benzinga.com/general/health-care/24/08/40381585/who-declares-mpox-public-health-emergency-coordinated-international-response-essential-to-hal"> on the outbreak.</a>
What Happened: The WHO announced a new plan in its fight against the outbreak of mpox. The plan comes as several companies are<a href="https://www.benzinga.com/news/24/08/40439999/geovax-labs-stock-continues-to-surge-whats-going-on"> ramping up efforts</a> to launch or increase output of mpox vaccines and treatment options.
The <a href="https://www.who.int/news/item/26-08-2024-global-strategic-preparedness-and-response-plan-launched-by-who-to-contain-mpox-outbreak">plan </a>calls for $135 million in funding for the WHO response and for member states and partners. Among the partners are communities, researchers and the Africa Centres for Disease Control and Prevention.
Funding will help with surveillance, prevention, readiness and the response to fight outbreaks of mpox, the WHO said.
The WHO said it will take part in strategic vaccination efforts to focus on high-risk individuals, which includes health care workers and those with close contact to recent cases.
"The mpox outbreaks in the Democratic Republic of the Congo and neighboring countries can be controlled, and can be stopped," WHO Director-General Dr. Tedros Adhanom Ghebreyesus said. 
"Doing so requires a comprehensive and coordinated plan of action between international agencies and national and local partners, civil society, researchers and manufacturers, and our Member States."
A virtual scientific conference will be held on Aug. 29 and Aug 30 to share mpox research and outbreak control goals from the WHO, Africa CDC and the National Institute of Allergy and Infectious Diseases.
Read Also: <a href="https://www.benzinga.com/news/large-cap/24/08/40559658/diagnostic-giants-labcorp-roche-to-ramp-up-testing-capacity-amid-global-concerns-over-new-mpox-str">Diagnostic Giants Labcorp, Roche To Ramp Up Testing Capacity Amid Global Concerns Over New Mpox Strain</a>
Why It's Important: The six-month plan is viewed as the critical step in stopping mpox outbreaks from spreading further or faster.
On Monday, Germany announced it will donate 100,000 mpox vaccine doses from its stockpile to help with the outbreak prevention, as reported by Reuters. Germany will keep a minimum stock of mpox vaccines, the report said. 
There have been 3,326 confirmed cases of mpox in Africa in 2024, with 590 deaths across 12 countries, according to the Africa Centres for Disease Control and Prevention, as <a href="https://thehill.com/policy/healthcare/4847877-who-releases-mpox-outbreak-plan/">reported </a>by The Hill. A total of 17,979 suspected mpox cases have been reported. 
Shares of companies that have mpox vaccines or treatments have been highly volatile over the last two weeks. The list includes Bavarian Nordic (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BVNRY#OTC">BVNRY</a>) and Emergent Biosolutions (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EBS#NYSE">EBS</a>), both of which have WHO-recommended vaccines
GeoVax Labs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOVX#NASDAQ">GOVX</a>) and SIGA Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) have also been highly volatile. GeoVax has a mpox vaccine in clinical development. SIGA Technologies has Tpoxx, which is a treatment for mpox.
Read Next: 
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<li><a href="https://www.benzinga.com/general/biotech/24/08/40554882/tonix-pharma-collaborates-with-worlds-largest-vaccine-manufacturer-for-mpox-vaccine">Tonix Pharma Collaborates With World&#8217;s Largest Vaccine Manufacturer For Mpox Vaccine</a></li>
</ul>
Illustration via Shutterstock.

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WHO Seeks $135M In Funding To Fight Mpox: Outbreak 'Can Be Controlled, And Can Be Stopped'

On Wednesday, SIGA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>)&nbsp;announced a new contract with the&nbsp;U.S. Department of Defense&nbsp;(DOD) to procure approximately <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40493842/siga-announces-new-contract-awarded-by-u-s-department-of-defense-for-the-procurement-of-9-million-" rel="noreferrer noopener">$9 million&nbsp;of TPOXX</a>.
This award is comprised primarily of oral TPOXX, with a small amount of intravenous (IV) TPOXX, and represents the third procurement contract award from the DOD over the past three years.
The company also received approximately&nbsp;$27 million&nbsp;to develop the post-exposure Prophylaxis indication for oral TPOXX.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/asia/24/08/40446949/mpox-variant-sparks-global-concern-as-europe-china-ramp-up-screening" rel="noreferrer noopener">Mpox Variant Sparks Global Concern As Europe, China Ramp Up Screening</a>.
Inclusive of this award, SIGA currently has approximately $154 million of outstanding oral and IV TPOXX&nbsp;orders, more than 85% of which were generated within the past three months.
Edison report adds that SIGA continues to advance its growth strategy, with recent contract wins from BARDA and the Department of Defense significantly boosting its order book.
The company is set to deliver IV TPOXX under orders from July 2023 ($25 million), and August 2022 ($8.4 million, of which $17.8 million from a $26 million order was already delivered in the first half of 2024).
These are part of approximately $155 million in outstanding TPOXX (oral and IV) orders.
SIGA anticipates delivering the remaining August 2022 IV TPOXX order and 80% of the BARDA oral TPOXX order in the second half of 2024.
While delivery timeline details are yet to be disclosed, Edison Group&#8217;s report notes that new DoD order to start at least being partially serviced in fiscal year 2025.
Recently, the National Institutes of Health&#8217;s National Institute of Allergy and Infectious Diseases (NIAID) announced topline results from a preliminary analysis of the PALM 007 trial of<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40394363/in-nih-cosponsored-monkeypox-virus-study-in-congo-siga-technologies-antiviral-tecovirimat-did-not" rel="noreferrer noopener"> tecovirimat for mpox</a>.
NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with mpox who were administered SIGA&#8217;s tecovirimat versus placebo, weighing on the share price.
Edison analysts expect an improvement in investor sentiment with the recent DoD contract win.
&#8220;We maintain that mpox continues to be an opportunity for SIGA on the heels of the WHO&nbsp;declaration of a global health emergency,&#8221; the analysts added.
Price Action: SIGA stock is up 4.07% at $9.72 at the last check on Friday.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/24/08/40528702/europe-approves-modernas-rsv-vaccine-for-adults-60-and-over" target="_blank" rel="noreferrer noopener">Europe Approves Moderna&#8217;s RSV Vaccine For Adults 60 And Over</a>.</li>
</ul>

Government

Government Contract Win May Improve Investor Sentiment For SIGA Tech After Disappointing Trial Data: Analyst

SIGA Technologies shares are trading higher after the company announced it was awarded a new contract by the U.S. Department of Defense for the procurement of $9 million worth of TPOXX.

SIGA Technologies, Inc. (SIGA) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>), a commercial-stage pharmaceutical company and leader in infectious diseases, today announced a new contract with the&nbsp;U.S. Department of Defense&nbsp;(DOD) for the procurement of approximately $9 million&nbsp;of TPOXX&#xAE; (Contract number: W911SR24C0030). This award is comprised primarily of oral TPOXX&#xAE;, with a small amount of intravenous (IV) TPOXX&#xAE;, and represents the third procurement contract award from the DOD over the past three years. &nbsp;
SIGA has been collaborating with the DOD's&nbsp;Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop the Post-exposure Prophylaxis (PEP) indication for oral TPOXX&#xAE;, and this work has been supported by a development contract with a value of approximately&nbsp;$27 million&nbsp;(Contract number: MCDC1901-001-2019-400) as well as a Cooperative Research and Development Agreement.

SIGA Awarded Contract By U.S. Department Of Defense For The Procurement Of $9M Of TPOXX

Authorities in Europe and China are expediting screening for a <a href="https://www.benzinga.com/general/health-care/24/08/40381585/who-declares-mpox-public-health-emergency-coordinated-international-response-essential-to-hal">deadly new version </a>of mpox that has spread across regions of Africa and has been found in Europe.
The European Center for Disease Prevention and Control on Friday raised its risk assessment for mpox and forecasted more imported cases after a new strain called clade I was confirmed in Sweden, <a href="https://www.axios.com/2024/08/19/mpox-mobilization-intensifies-outside-of-africa">Axios</a> reported.
Pakistan&#8217;s health ministry reported Friday that it identified an mpox case and was conducting sequencing to determine if it is the new strain.
China&#8217;s customs administration said it would look for signs of mpox in people and goods entering the country over the next six months, the state-run, English-speaking news TV channel CTGN reported.
According to the <a href="https://www.cdc.gov/cfa-modeling-and-forecasting/mpox-transmission-technical-brief/index.html">CDC</a>, the Democratic Republic of the Congo&#8217;s ongoing mpox outbreak, driven by the more transmissible and severe Clade I virus, involves multiple transmission modes, including household and sexual exposures, with 70% of cases in children under 15.
Read Also: <a href="https://www.benzinga.com/news/24/08/40444353/virax-biolabs-shares-climb-with-mpox-cases-what-to-know">Virax Biolabs Shares Climb With Mpox Cases: What To Know</a>
More than 16,000 new cases and 511 deaths have been reported in Africa this year, and nine countries have reported confirmed new cases of mpox in recent weeks.
The World Health Organization last week declared mpox a global health emergency, acknowledging that it would likely spread across Africa and outside the continent. The organization is working with countries and drugmakers on vaccine donations.
Clade I is different from the less severe Clade II strain of mpox that caused the global outbreak in 2022, but they both share similar flu-like symptoms and produce a rash that at first resembles pimples or blisters.
In the U.S.,&nbsp;the Centers for Disease Control and Prevention has told doctors to watch out for the new mpox strain, but it also said that the risk to the public is very low.
Two vaccines &#8212; Jynneos, made by Bavarian Nordic (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BVNRY#OTC">BVNRY</a>) and LC16, from KM Biologics &#8212; have received emergency authorizations. Bavarian Nordic has asked the European Union&#8217;s drug regulator to expand Jynneos&#8217; use to 12- to 17-year-olds, an age group especially at risk from clade 1.
A National Institutes of Health study showed the smallpox antiviral drug tecovirimat, which is made by SIGA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIGA#NASDAQ">SIGA</a>) did not lower the duration of mpox lesions among children and adults with Clade I mpox in the DRC.
Price Action: Shares of Bavarian Nordic were down 1.79% to $13.70 as SIGA declined 0.29% to $10.46 at the time of publication Monday, while most of the exchange-traded funds that cover the segment gained.
<ul>
<li>Amplify Treatments, Testing and Advancements ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GERM#NYSE">GERM</a>) fell 0.35%.</li>
<li>Roundhill Acquirers Deep Value ETF ARCA: DEEP) gained 0.62%.</li>
<li>Invesco NASDAQ Future Gen 200 ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQS#NASDAQ">QQQS</a>) picked up 0.80%.</li>
<li>VictoryShares Small Cap Free Cash Flow ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SFLO#NASDAQ">SFLO</a>) went up 0.93%.</li>
<li>First Trust Dow Jones Select MicroCap Index Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FDM#NYSE">FDM</a>) rose 0.46%.</li>
</ul>
Read Now:
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<li><a href="https://www.benzinga.com/news/24/08/40439999/geovax-labs-stock-continues-to-surge-whats-going-on">GeoVax Labs Stock Continues To Surge: What&#8217;s Going On?</a></li>
</ul>
Image created using artificial intelligence via Midjourney.

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Mpox Variant Sparks Global Concern As Europe, China Ramp Up Screening

Press Releases

Wolf Haldenstein Adler Freeman & Herz LLP announces that it is investigating SIGA Technologies, Inc. for potential violations of federal securities laws

Legal

SIGA Technologies (SIGA) Shares Tumble After Mpox Therapy Fails, Chief Medical Officer Terminated - Hagens Berman

Bragar Eagel & Squire, P.C. Is Investigating CSX, Stride, and SIGA and Encourages Investors to Contact the Firm

SIGA to Host Business Update Call on November 7 Following Release of Third-Quarter 2024 Financial Results

SIGA Reports Financial Results for Three and Nine Months Ended September 30, 2024

Interim Results from STOMP Study of SIGA's Tecovirimat in Treatment of Mpox Announced

TEPOXX (tecovirimat) Approved in Japan for the Treatment of Orthopoxviruses

SIGA to Host Business Update Call on March 11, 2025 Following Release of Fourth-Quarter and Full Year 2024 Financial Results

SIGA Reports Financial Results for Three and Twelve Months Ended December 31, 2024

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