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Apple, Inc. engages in the design, manufacture, and sale of smartphones, personal computers, tablets, wearables and accessories, and other varieties of related services. It operates through the following geographical segments: Americas, Europe, Greater China, Japan, and Rest of Asia Pacific. The Americas segment includes North and South America. The Europe segment consists of European countries, as well as India, the Middle East, and Africa. The Greater China segment comprises China, Hong Kong, and Taiwan. The Rest of Asia Pacific segment includes Australia and Asian countries. Its products and services include iPhone, Mac, iPad, AirPods, Apple TV, Apple Watch, Beats products, AppleCare, iCloud, digital content stores, streaming, and licensing services. The company was founded by Steven Paul Jobs, Ronald Gerald Wayne, and Stephen G. Wozniak in April 1976 and is headquartered in Cupertino, CA.

Apple Inc

Apple is experiencing significant volatility driven by reports of engineering setbacks affecting the launch of its anticipated foldable iPhone, alongside ongoing legal pressures from a patent infringement dispute. While some market participants are reacting with caution to these headwinds, the community remains actively divided, with many bulls dismissing the news as temporary noise and focusing on the company's long-term ecosystem stability.

GameStop Corp. engages in offering games and entertainment products through its ecommerce properties and stores. The firm’s stores and ecommerce sites operate primarily under the names GameStop, EB Games, and Micromania. It operates through the following geographical segments: United States, Canada, Australia, and Europe. The company was founded by Daniel A. DeMatteo in 1996 and is headquartered in Grapevine, TX.

Gamestop Corporation - Ordinary Shares - Class A

GameStop Corp

GameStop is trending as investors remain focused on its high short interest and potential for a squeeze, with ongoing community debate regarding the company's lack of major acquisitions and frustration over stagnant price action. Market participants are actively comparing GME's current activity to historical trading patterns, closely monitoring volume, and analyzing the impact of off-exchange routing on price discovery.

Axon Enterprise, Inc. engages in the development, manufacture, and sale of conducted electrical weapons for personal defense. It operates through the TASER segment and Software and Sensors segment. The TASER segment sells conducted electrical weapons, accessories, and other related products and services. The Software and Sensors segment includes devices, wearables, applications, cloud, and mobile products. The company was founded by Patrick W. Smith and Thomas P. Smith on September 7, 1993 and is headquartered in Scottsdale, AZ.

Axon Enterprise Inc

Axon Enterprise is experiencing significant downward pressure as investors rotate out of high-multiple software stocks, leading the community to intensely debate whether the current slide represents a fundamental repricing or a major buying opportunity. Despite recent announcements of new AI-driven product tools, the stock continues to face sharp volatility and sentiment shifts as stakeholders express frustration over the ongoing sell-off while waiting for upcoming earnings and industry events to provide a clear path forward.

Broadcom Inc. is a global technology company, which designs, develops, and supplies semiconductors and infrastructure software solutions. It operates through the Semiconductor Solutions and Infrastructure Software segments. The Semiconductor Solutions segment refers to product lines and intellectual property licensing. The Infrastructure Software segment relates to mainframe, distributed and cyber security solutions, and fibre channel storage area networking business. The company was founded in 1961 and is headquartered in Palo Alto, CA.

Broadcom Inc

Broadcom is currently attracting significant attention following the announcement of a landmark long-term partnership with Google to co-develop custom AI chips through 2031. The community is actively discussing this as a pivotal move that cements the company's role as essential infrastructure for AI hyperscalers, with many investors debating whether this solidifies a bullish long-term outlook despite recent macro-driven volatility.

Avis Budget Group, Inc. engages in the provision of vehicle sharing and rental services. It operates through the Americas and International segments. The Americas segment includes vehicle rental and car sharing operations in North America, South America, Central America, and the Caribbean. The International segment is involved in vehicle rental and car sharing operations in Europe, the Middle East, Africa, Asia, and Australasia. The company was founded in 1946 and is headquartered in Parsippany, NJ.

Avis Budget Group Inc

Avis Budget Group is experiencing significant volatility driven by a high short interest and aggressive retail trading, fueling intense speculation about a potential short squeeze. Investors remain polarized, with community discussion split between those capitalizing on the parabolic price action and others warning that the company's underlying fundamentals are weak.

Hertz Global Holdings, Inc. engages in the vehicle rental business through the Hertz, Dollar, and Thrifty brands. It operates under the Americas Rental Car (RAC) and International Rental Car (RAC) segments. The Americas RAC segment focuses on operations in the United States, Canada, Latin America, and the Caribbean. The International RAC segment includes the provision of rental and sales of vehicles and value-added services in other locations. The company was founded in 1918 and is headquartered in Estero, FL.

Hertz Global Holdings Inc. - Ordinary Shares (New)

Hertz Global Holdings Inc

Hertz is seeing heightened volatility and active options sentiment as traders debate its potential for a short squeeze, particularly as the stock's performance is often compared to sector peer Avis. Investors are closely monitoring price action around the $6 level while keeping a watchful eye on high short interest, institutional positioning, and the broader macro environment for travel demand.

Intel Corp. engages in the design, manufacture, and sale of computer products and technologies. It delivers computer, networking, data storage, and communications platforms. The firm operates through the following segments: Client Computing Group (CCG), Data Center and AI (DCAI), Intel Foundry Services (IFS), and All Other. The CCG segment consists of platforms designed for notebooks, 2-in-1 systems, desktops, tablets, phones, wireless and wired connectivity products, and mobile communication components. The DCAI segment delivers solutions to cloud service providers and enterprise customers, along with silicon devices for communications service providers and high-performance computing customers. The IFS segment refers to full stack solutions created from the foundry industry ecosystem. The All Other segment represents results from other non-reportable segments and corporate-related charges. The company was founded by Robert Norton Noyce and Gordon Earle Moore on July 18, 1968, and is headquartered in Santa Clara, CA.

Intel Corp.

Intel Corp

Intel is trending as investors rally behind a strategic buyback of its Irish manufacturing stake and growing optimism surrounding its foundry business, including potential high-profile partnerships with cloud giants. The community is actively debating the stock's turnaround potential, with many discussing the impact of geopolitical macro factors on share price volatility while speculating on significant upside once the company's long-term foundry initiatives fully materialize.

NuScale Power Corp. provides proprietary and innovative advanced small modular reactor (SMR) nuclear technology, with a mission to help power the global energy transition by delivering safe, scalable, and reliable carbon-free energy. Its products include VOYGR SMR Plants and Energy Exploration (E2) Centers. The company was founded by José N. Reyes in 2007 and is headquartered in Corvallis, OR.

NuScale Power Corporation - Ordinary Shares - Class A

NuScale Power Corp

NuScale Power is facing heightened scrutiny and volatility ahead of its quarterly earnings release as shareholders weigh recent class-action litigation concerns against the company's long-term potential in the burgeoning AI-driven energy sector. The community remains deeply divided, with some investors aggressively accumulating shares as a long-term play on SMR adoption, while others are bracing for potential downside and expressing frustration over the stock's extended downward trend.

TeraWulf, Inc. owns and operates fully integrated environmentally clean bitcoin mining facilities in the United States. It will generate domestically produced bitcoin powered by nuclear, hydro, and solar energy. It operates through the Digital Asset Mining and HPC Leasing segments. The company was founded by Paul B. Prager and Nazar M. Khan on February 8, 2021 and is headquartered in Easton, MD.

TeraWulf Inc

TeraWulf is seeing strong investor interest driven by aggressive institutional call buying and a positive growth outlook, as market participants increasingly view the firm as an AI and high-performance computing infrastructure play rather than just a crypto miner. Community sentiment remains overwhelmingly bullish, with active discussions focusing on the company's ability to secure large-scale hyperscaler partnerships and their ongoing expansion of energy-efficient data center capacity.

Pfizer Inc. is a research-based global biopharmaceutical company, which engages in the discovery, development, manufacture, marketing, sales and distribution of biopharmaceutical products worldwide. The firm works across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases. The company was founded by Charles Pfizer Sr. and Charles Erhart in 1849 and is headquartered in New York, NY.

Pfizer Inc.

Pfizer Inc

Pfizer is experiencing heightened market attention as investors weigh the company's defensive dividend profile against concerns over patent cliffs and mixed clinical trial results. While the community remains divided over management's ability to drive growth through new oncology pipeline assets and obesity-related efforts, recent activity is heavily influenced by speculative M&A rumors and intense focus on long-term patent litigation.

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Regulatory Wins, Capital Flows, and Global Expansion Drive Market Momentum

A wave of regulatory clarity, strategic financing, and global expansion is reshaping pockets of the market, with companies across biotech, mobility, and emerging healthcare infrastructure positioning for outsized growth. $MGRX, $TOVX, $ZYBT, $FFAI, $TGNT

March 23, 2026 08:00 ET– Successful meeting with FDA enables advancement into proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC –– Combined feedback from FDA and previously from EMA enables company to finalize protocol for pivotal Phase 3 clinical trial while pursuing strategic funding opportunitiesROCKVILLE, Md., March 23, 2026 (GLOBE NEWSWIRE) — Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC).The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=1rhvDbgOJNdn_nUS60Ig7uHA0o8bKL-nrG5Vgf7tmGuUHPng-K2dgfCMRcGxfoDLmwPOqMeQBAbEeYk-fIugIhzcdhPbc9esREMtde3tOonEFzmribZRnTIWHFT6gUW2QNJ2aD-3k9TWTs0IXDAiuZppzMiUaJhQfNERTE9RduADRqdvYcRVExArCGNKRAQ_bB2BPzUaLTDRF3PpX2vBQ6PfjjLrLqKP3xhNf72bvgdvZ5iivNwlp5HUUpjq05ttiExuN7JvBT6uodYUmj4_n8J1nMOPRnqid-lUGGAIX70z0Lvgos5bElPUMC7ys--dQaofIV3vmaXWFUKi5DT9-14irY66dWDSGwsvQV1DeZo=">announced</a> in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival (OS), progression free survival (PFS) and Duration of Response (DoR) compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes. .Consistent with scientific advice <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=SMqIV6-Aw0DqxEsoI1oXVyQk7KVkrHtJRbGU10eC4to7xxdbXVlBmB9IENgyZcIrYU-UPllZcui7bYKoJjd1ivEfsHQ5UlcOhXClGyybPz5OaHEIdbLC5r_2FgM_dATK3EyoEULF2VGO499-F9o5wua4jLUiULU3ly__A3NB6_AVxmtKuEYShn1o5_E-_BpHJCgw0Kpd-x8jTywv1_3f62pUySpKKFVD87UOnFqV84CRnixHBa5Dw-nYtAjHkwnfSNR174YmrETtQbLgXSWrTAV6OnM8NWI5gmGcXAR6BCU61vvwqYI3z5Vd2p_0mViCP7Cn7gZkgAPkWtnHt_ycD4Rm6Sj9W5cn13fAoVwfc3YTloOkksBXc-E2-uUzLOoo">previously received</a> from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the FDA advised that a potential biologics licensing application (BLA) for VCN-01 in metastatic PDAC could be supported by Theriva’s proposed Phase 3 clinical trial (if successful) comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated “macrocycles” (enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial), the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints (including progression free survival), and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.“We are very pleased to align with the FDA on the key elements of our proposed pivotal Phase 3 trial evaluating VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Data from our VIRAGE Phase 2b study demonstrated improved outcomes in PDAC patients treated with 2 doses of VCN-01 and we believe that administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel that may further improve patient outcomes. The combined feedback from the FDA and the EMA now enables us to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding and/or partnerships, which, if successful, may deliver a novel and effective treatment option for patients with this difficult to treat solid tumor cancer.”About Pancreatic Ductal AdenocarcinomaCancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.About VCN-01VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.About Theriva™ Biologics, Inc.Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial is also on-going with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva Biologics’ website at <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=nAtR_zvKbQYiT_abtVt-fk1-2xkCBRGL0haqvZx_DxD2TkOxKH1UDEoWPZ7EFjD79VGBiu410jZOM8uX-E2RGA9Jirib4q0CeKkfBDFZODA=">www.therivabio.com</a>.Forward-Looking StatementThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding advancing into a proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC; the feedback from the FDA and European regulatory agencies enabling a pivotal Phase 3 study protocol to be finalized and pursuit of non-dilutive strategic funding opportunities; the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes; the proposed Phase 3 clinical trial (if successful) supporting a potential BLA; administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel improving improve patient outcomes; the combined feedback from the FDA and the EMA enabling the Company to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding of partnerships; and delivering a novel and effective treatment option for patients with difficult to treat solid tumor cancer. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize the Phase 3 study protocol and file a BLA; the Company’s ability to obtain development funding and/or partnerships; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in PDAC patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat patients with PDAC; regulatory limitations relating to the Company’s ability to promote or commercialize their product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s and VCN’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.For further information, please contact: Investor Relations: Kevin Gardner LifeSci Advisors, LLC <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=ZBmVseRAP6Y3WmUUQnXAHGcU_iKd3-EiFhbuuYURT65nMBb5hmOtGZmKhEwKNRqWFZLOF_5yyE4Ze37_q3pkRPTzNr179Sk9n8qUjblF3rfWeZMc7vsrvZZI4aeb2rd5">kgardner@lifesciadvisors.com</a>Source: Theriva Biologics, Inc.Note: This article has been published automatically by sourcing from Access Newswire. The Stocktwits editorial team did not edit this article.

Theriva™ Biologics Announces Positive End-of-Phase 2 Meeting with U.S. FDA Regarding the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma

FDA aligns with Theriva Biologics on VCN-01 Phase 3 trial design for pancreatic cancer treatment.

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Theriva™ Biologics Reports Full-Year 2025 Operational Highlights and Financial Results

Theriva Biologics advances cancer pipeline, licenses asset, and extends cash runway into 2027.

- Theriva received a $300,000 upfront payment at signing and is eligible for up to $38M in development, regulatory, and sales milestones along with tiered single-digit royalties on net product sales -- Rasayana to assume all responsibility and costs for SYN-020 development and commercialization -ROCKVILLE, Md., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported the out-licensing of SYN-020, to Rasayana Therapeutics, Inc., a privately-held company targeting the Gut-Organ axis biology to discover and deliver transformative gut-targeted medicines for patients with chronic inflammatory diseases.&nbsp;SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) produced under cGMP conditions and formulated for oral delivery to the small intestine. It is designed to reduce fat absorption and intestinal inflammation; tighten the gut barrier to mitigate leaky gut; and promote a healthy microbiome. These modes-of-action mean SYN-020 has the potential to address multiple metabolic and inflammatory disorders and diseases associated with aging. SYN-020 was well tolerated in Phase 1 clinical studies and is now poised to enter Phase 2 clinical testing with Rasayana.“We are extremely pleased to complete the license of SYN-020 to Rasayana, which will enable the advancement of this important GI asset from our portfolio while we focus on our lead pancreatic cancer program, VCN-01,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We believe SYN-020 is a highly versatile asset with therapeutic opportunities in multiple high-value indications arising from GI dysfunction. The Rasayana team and advisors are world leaders in IAP and its clinical applications, and they are well positioned to advance SYN-020 development, ideally delivering benefits for patients and value for Theriva shareholders.”&nbsp;“We are thrilled to partner with Theriva Biologics on the development of SYN-020,” said Vidisha Mohad, Founder and CEO of Rasayana Therapeutics. “SYN-020 offers a fundamentally innovative approach to addressing gastrointestinal dysfunction and its systemic health implications. Having worked on SYN-020 research during my postdoctoral training at Harvard, I have deep conviction in its underlying biology, scientific rigor, and therapeutic potential. Importantly, its cost-effective profile reflects our shared commitment to making transformative treatments accessible to patients who need them most. At Rasayana, we are focused on advancing therapies that target the Gut-Organ Axis to extend healthspan. SYN-020’s novel biology, strong safety profile, and compelling clinical data make it an ideal fit for our pipeline. We look forward to building on Theriva’s foundational work and accelerating this program to deliver meaningful outcomes for patients worldwide”.Under the terms of the agreement, Rasayana is granted an exclusive, worldwide license, with the right to sublicense, to develop and commercialize SYN-020 for therapeutic and diagnostic use. Theriva received a $300,000 up-front payment at signing and is eligible for up to $16M in development and regulatory milestones, tiered single digit royalties on net product sales, and up to $22M in milestones payable upon achievement of certain annual aggregate net sales. Rasayana will assume all responsibility and costs for SYN-020 development and commercialization.&nbsp;About Theriva™ Biologics,&nbsp;Inc.Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; and (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva Biologics’ website at&nbsp;www.therivabio.com.&nbsp;About Rasayana Therapeutics, Inc.Rasayana Therapeutics, Inc. is a biotechnology company targeting the Gut-Organ axis biology to address chronic inflammatory diseases. The company is pioneering a new class of gut-inflammation targeting therapies for gastrointestinal, cardiometabolic, and neurodegenerative diseases. Rasayana’s mission is to develop novel, cost-effective medicines that extend healthspan and improve quality of life for patients globally. For more information, visit Rasayana Therapeutics website at <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=hLZTfPu2_0SymExk02qvUbsHQ8p-vzyMwruJmpooYqOW89Jp-kMpNRBCkyuLct-aQ1rNR0NhLwOo3WO03RLPjHGEKhHV6et5B6zWcDjISACDR3DgYde0lTEIZ5vW-puz">www.rasayanatherapeutics.com</a>Forward-Looking StatementThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding SYN-020 having the potential to address multiple metabolic and inflammatory disorders and diseases associated with aging; SYN-020 being poised to enter into Phase 2 clinical testing with Rasayana; enabling the advancement of this important GI asset; SYN-020 being a highly versatile asset with therapeutic opportunities in multiple high-value indications arising from GI dysfunction; and Rasayana being well positioned to advance SYN-020 development and deliver benefits for patients and value for Theriva shareholders; and SYN-020’s therapeutic potential accelerating the SYN-020 program to deliver meaningful outcomes for patients worldwide; and Theriva receiving up to $16M in development and regulatory milestones, tiered single digit royalties on net product sales, and up to $22M in milestones payable upon achievement of certain annual aggregate net sales . Important factors that could cause actual results to differ materially from current expectations include, among others, Rasayana’s ability to reach clinical milestones when anticipated including entering into Phase 2 clinical testing of SYN-020 , the ability generate clinical data that establishes SYN-020 may deliver benefits for patients and have therapeutic potential; Rasayana’s ability to achieve development and commercialization milestones as well as sales that result in payments to Theriva; SYN-020 and the Company’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and Rasyana’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s and Rasayana’s products, developments by competitors that render such products obsolete or non-competitive, the ability to maintain license agreements, the continued maintenance and growth of the Company’s patent estate, the ability to continue to remain well financed and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.For further information, please contact:Investor Relations: Kevin Gardner LifeSci Advisors, LLC kgardner@lifesciadvisors.comSource: Theriva Biologics, Inc.Note: This article has been published automatically by sourcing from Access Newswire. The Stocktwits editorial team did not edit this article.

Theriva™ Biologics Licenses SYN-020 to Rasayana Therapeutics for Multiple Indications

Theriva Biologics licenses SYN-020 to Rasayana for $300k upfront and up to $38M in future milestones.

- Safety and clinical outcomes of Phase 1 study of VCN-01 (zabilugene almadenorepvec) in refractory retinoblastoma patients to be presented in an invited session at the 41st Asia-Pacific Academy of Ophthalmology (APAO) Congress in Hong Kong on Saturday, 07 February 2026 –- Preclinical data will highlight synergistic antitumor activity for the combination of topotecan and VCN-01 that may improve outcomes in refractory retinoblastoma patients with difficult-to-treat vitreous seeds -&nbsp;ROCKVILLE, Md. and BARCELONA, Spain, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced an invited presentation of clinical outcomes and safety data from the investigator sponsored Phase 1 clinical study (NCT03284268) evaluating the safety and tolerability of two intravitreal injections of VCN-01 (zabilugene almadenorepvec) in pediatric patients with intraocular retinoblastoma that was refractory to systemic, intra-arterial, or intravitreal chemotherapy, and for whom enucleation was the only recommended treatment. Preclinical data describing the synergistic antitumor effects observed when topotecan (a standard of care chemotherapy for retinoblastoma) is coadministered with VCN-01 will also be presented. These data will be presented during a retinoblastoma focused session at the upcoming Asia-Pacific Academy of Ophthalmology (APAO) Congress (held in conjunction with the 37thAnnual Scientific Meeting Hong Kong Ophthalmological Symposium) taking place in Hong Kong, China, 5-8 February 2026.&nbsp;Details of the presentation can be found <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=tNHDcbYkw6QgsozmQVCV8LQ4aTYsU_XNvjMA_g5TstEs-pckD_WX3j9BnnaHV3_z_8or3c9jjqdEB_nzrNUBX_jnp8z0HlzdOtuLudXTyKWHRFH-9eJtNAXRMj_D30Uj">online</a> and below.<ul><li>Presenting Author: Dr. Jaume Català-Mora, Pediatric Ophthalmologist, Sant Joan de Déu-Barcelona Children’s Hospital</li><li>Title: Update on Oncolytic Adenovirus VCN-01 Trial in Retinoblastoma</li><li>Session: 0211 Retinoblastoma in Association With Asian Retinoblastoma Group</li><li>Date &amp; Time: Saturday 07 February, 2026, at 4:46 PM HKT (3:46 AM US EDT)</li><li>Location: Rooms S224-225, Level 2, Hong Kong Convention and Exhibition Centre (HKCEC) &nbsp;</li></ul>“We are very pleased with the on-going international interest in the novel clinical and preclinical findings by our collaborators treating retinoblastoma patients at Sant Joan de Déu-Barcelona Children’s Hospital,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Effective treatment of refractory retinoblastoma with vitreous seeds remains a significant unmet medical need for pediatric patients with this condition worldwide. Based on our previously reported Phase 1 clinical <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=ndEUifZXBX0beJKpblsn4l3WNy9v6SPzYN6472Z3tMuJHqxLesgsKvlFh8uhvvcve7VvQloR2cb6CQLkjepQg6nwP98Ywnl5KBtO-ct4zKeDD8Jz0o3wHfOvKHaNIGeu">data</a>, and the emerging preclinical findings, we believe that the intravitreal combination of VCN-01 and topotecan provides an exciting new opportunity to address this challenge and help preserve the eyes and quality-of-life of children with this rare but devastating cancer. VCN-01 has Orphan Drug and Rare Pediatric Disease designations for the treatment of retinoblastoma, and we are currently refining a potential pivotal clinical trial design in this indication for discussion with regulatory agencies.”About VCN-01VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 140 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov. VCN-01 has Orphan Drug designation from the EMA and both Orphan Drug designation and Fast Track designation from the FDA for the treatment of pancreatic cancer. VCN-01 also has Orphan Drug designation and Rare Pediatric Diseases designation from the FDA for the treatment of retinoblastoma.&nbsp;About RetinoblastomaRetinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 - 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population &lt; 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In Europe, retinoblastoma has an estimated incidence rate of 1 per 13,844 live births (14.1 per million children under the age of 5) with approximately 300 children diagnosed per year (<a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=bdwE4r7sy1MWwrIxf22JOGA7c7zt9J7zsbC2MgiwMD8ROr7SJbrucThnwSGxmDz3MR6uvdjupNm4w-W6JM2T5_ku9I7MZPAeSsHo5R3xqvYwAeWlPPIsoPoud3fUA4hI7f9FTUupCfakveniiQ3-dA==">Stacey et al. 2021</a>). Preserving life and preventing the loss of an eye, blindness, and other serious effects of treatment that reduce the patient’s life span or the quality of life remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.&nbsp;About Theriva™ Biologics, Inc.Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L. , has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates are: (1) VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/Tracker?data=dhFmQsJ81g_9OUj8i5TBL_CFPWIb7PtqMyHERYhfHsp6p66lc6VlPfbfa-7P-87mJe7mfoiWVuHGo4O2RW3qYaNVBN7de2bMxaS2kOzZKz0=">www.therivabio.com</a>.&nbsp;Forward-Looking StatementThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding preclinical data highlighting synergistic antitumor activity for the combination of topotecan and VCN-01 that may improve outcomes in refractory retinoblastoma patients with difficult-to-treat vitreous seeds; the intravitreal combination of VCN-01 and topotecan providing an exciting new opportunity to address the challenge of effective treatment of refractory retinoblastoma withvitreous seeds retinoblastoma and a potential pivotal clinical trial design in retinoblastoma These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to design a pivotal clinical trial in retinoblastoma for discussion with the FDA; VCN-01’s ability to have positive results in future trials for the treatment of retinoblastoma and other therapeutic benefits; the Company’s ability to reach clinical milestones when anticipated including enrolling the expected number of patients in each trial; the Company’s product candidates, including VCN-01, demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical trial enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’s patent estate, the ability to continue to remain well financed, and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.For further information, please contact:Investor Relations: Kevin Gardner LifeSci Advisors, LLC kgardner@lifesciadvisors.comSource: Theriva Biologics, Inc.Note: This article has been published automatically by sourcing from Access Newswire. The Stocktwits editorial team did not edit this article.

Theriva™ Biologics Announces Upcoming Presentation of Data from VCN-01 Retinoblastoma Phase 1 Clinical Trial at APAO 2026

Theriva Biologics to present VCN-01 Phase 1 and preclinical data for retinoblastoma at APAO 2026.

Shares of Theriva Biologics fell sharply after the company priced a public offering of up to 6.8 million shares of common stock and accompanying warrants at $1.10 per unit.&nbsp;The offering is expected to raise nearly $7.5 million in gross proceeds, before deducting placement agent fees and other offering expenses.&nbsp;The warrants will be exercisable immediately at the same price of $1.10 per share and will expire in five years.Theriva shares closed at $0.81, down 41% on Wednesday. After hours, shares dropped to $0.75, reflecting a further 7.4% decline.The offering follows the announcement of positive topline results from the Virage Phase 2b clinical trial, which evaluated VCN-01 in combination with standard chemotherapy for treating metastatic pancreatic ductal adenocarcinoma (PDAC).&nbsp;The study, which included 96 newly diagnosed metastatic PDAC patients, showed that patients receiving VCN-01 plus chemotherapy had a median overall survival (OS) of 10.8 months, compared to 8.6 months in the control group receiving chemotherapy alone.&nbsp;Additionally, the VCN-01+chemotherapy arm showed a median duration of response (DoR) of 11.2 months, double that of the control arm’s 5.4 months.Theriva intends to use the proceeds primarily for working capital, general corporate purposes, and research and development.&nbsp;A portion of the funds may also be used for manufacturing scale-up or potential acquisitions, although no specific deals are currently in place.&nbsp;A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.On Stocktwits, sentiment was described as ‘extremely bullish’, with ‘high’ message volume fueling speculation about the company’s future.&nbsp;One user speculated that a buyout could still be in play, potentially happening before September 30. This user noted that while the offering would dilute the stock, buying at current levels could offer significant upside in the event of a buyout.<stembedurl>https://stocktwits.com/exwallstcfo/message/613861348</stembedurl>Another user drew comparisons between Theriva and Pasithea Therapeutics, suggesting that both companies had positive news followed by public offerings.&nbsp;The user speculated that the offering could have been strategically timed to benefit from a price pump.<stembedurl>https://stocktwits.com/Staceykyusa/message/613855430</stembedurl>Shares of Theriva have fallen nearly 51% so far this year.For updates and corrections, email newsroom[at]stocktwits[dot]com.

In this photo illustration, a chart depicting stock market crash, is displayed on a mobile phone screen in Ankara, Turkiye on August 5, 2024. (Photo by Osmancan Gurdogan/Anadolu via Getty Images)

Theriva Biologics Shares Plunge After Pricing $7.5M Offering: Retail Sentiment Still Strong

The offering comes on the heels of encouraging data from the Virage Phase 2b trial, which demonstrated significant improvements in overall survival and duration of response for patients receiving Theriva's lead product candidate, VCN-01.

Equity

The offering comes on the heels of encouraging data from the Virage Phase 2b trial, which demonstrated significant improvements in overall survival and duration of response for patients receiving Theriva's lead product candidate, VCN-01, in combination with standard chemotherapy. 

Shares of <a href="https://stocktwits.com/symbol/TOVX">Theriva Biologics Inc</a>. (TOVX) surged over 30% on Friday, making it one of the top trending tickers on Stocktwits, coming on the heels of several key developments that have caught the attention of retail investors.The rally began on Thursday after Theriva Biologics announced it had received a notice of allowance for a U.S. patent application related to treating C. difficile and other antibiotic-induced gastrointestinal tract conditions.Additionally, Theriva recently secured Rare Pediatric Drug Designation (RPDD) from the U.S. FDA for VCN-01, its experimental treatment for retinoblastoma, the most common type of eye cancer in children. The condition affects 200 to 300 children annually in the U.S., mostly infants and young children, according to the American Cancer Society.“We continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma,” Steven A. Shallcross, CEO of Theriva Biologics had said earlier.He added that the company also reported encouraging results from an investigator-sponsored Phase 1 trial evaluating VCN-01 in pediatric patients with refractory retinoblastoma.Beyond the scientific advancements, Theriva also executed a 1-for-25 reverse stock split, which began trading on a split-adjusted basis on August 26.Earlier this month, Theriva reported a Q2 loss of $0.43 per share, significantly narrower than the consensus estimate of a $0.70 loss. The company also said it was committed to expanding its portfolio of therapeutic combinations and reducing cash burn to extend its runway.<stembedurl>https://stocktwits.com/ANTHONYMOMO/message/584669011</stembedurl>These developments have sparked some retail interest, with TOVX’s follower count rising by 1.14% (suggest avoid saying considerable retail interest with 1.14% rise) in the past week, and message volume on Stocktwits jumping significantly.Despite being down nearly 50% year-to-date, the recent string of positive catalysts has sparked renewed optimism among investors about Theriva’s long-term prospects.Read Next: <a href="Lululemon Stock Rises After Mixed Q2 Report, But Retail Optimism Fades On Lowered Outlook">Lululemon Stock Rises After Mixed Q2 Report, But Retail Optimism Fades On Lowered Outlook</a>&nbsp;&nbsp; &nbsp;

TOVX Stock Jumps 30% As New Patent, FDA Designation Boost Investor Sentiment

Theriva recently secured Rare Pediatric Drug Designation (RPDD) from the U.S. FDA for VCN-01, its experimental treatment for retinoblastoma, the most common type of eye cancer in children.

What’s Getting Investors So Excited About TOVX Stock?

Theriva Biologics, Inc. is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. Its product portfolio includes SYN-020 and SYN-004. SYN-020 is intended to prevent the antibiotic-mediated microbiome damage, C. difficile infections (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host disease (aGVHD) in allogeneic HCT recipients. SYN-004 is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance. The company was founded by Steven H. Kanzer on January 8, 2001 and is headquartered in Rockville, MD.

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