Core Insights - Atea Pharmaceuticals is advancing its global Phase 3 clinical program for the treatment of Hepatitis C Virus (HCV) with a combination regimen of bemnifosbuvir and ruzasvir, expecting topline results from the North American trial by mid-2026 [1][3][6] - New data presented at The Liver Meeting 2025 supports the antiviral potency and unique dual mechanism of action of bemnifosbuvir against HCV, positioning it as a potential best-in-class therapy [1][4][8] - The company is also expanding its antiviral pipeline with a new Hepatitis E Virus (HEV) development program, addressing unmet medical needs in immunocompromised patients [1][5][10] Patient Enrollment and Trials - Patient enrollment for the C-BEYOND trial in the US and Canada is on track to be completed by the end of 2025, while the C-FORWARD trial outside North America is expected to finish enrollment by mid-2026 [3][12] - Each Phase 3 trial is enrolling approximately 880 treatment-naïve patients, comparing the bemnifosbuvir and ruzasvir regimen to the existing regimen of sofosbuvir and velpatasvir [12][13] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $329.3 million, a decrease from $454.7 million at the end of 2024 [19][29] - Research and development expenses increased by $12.2 million year-over-year, primarily due to external spending related to the HCV Phase 3 clinical development program [20] Mechanism of Action - Bemnifosbuvir exhibits a unique dual mechanism of action against HCV, inhibiting both HCV RNA replication and the assembly/secretion of new virions, which enhances its antiviral efficacy [7][8] - The combination regimen of bemnifosbuvir and ruzasvir is designed to suppress the virus at multiple critical stages, potentially leading to a shorter treatment duration of approximately 7 to 8 weeks [14] Upcoming Events - Atea will host a virtual event on November 13, 2025, featuring leading HCV clinical experts discussing current challenges in HCV treatment and the potential benefits of next-generation therapies [16][17]

Data from the dose optimization trial expected soonProLectin-M is positioned as the first oral antiviral sugar chemistry drug BOSTON, MASSACHUSETTS, Oct. 29, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company pioneering innovative therapies for viral diseases, is pleased to announce the successful completion of its second randomized double-blind, placebo-controlled clinical trial for its leading broad-spectrum antiviral drug candidate, ProLectin-M. ...

Data from the dose optimization trial expected soonProLectin-M is positioned as the first oral antiviral sugar chemistry drug BOSTON, MASSACHUSETTS, Oct. 29, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company pioneering innovative therapies for viral diseases, is pleased to announce the successful completion of its second randomized double-blind, placebo-controlled clinical trial for its leading broad-spectrum antiviral drug candidate, ProLectin-M. ...

Core Viewpoint - Theralase Technologies Inc. has announced the peer-reviewed publication of preclinical data demonstrating that its antiviral candidate Ruvidar® is more effective than Acyclovir® and Metformin® in treating Herpes Simplex Virus Type 1 (HSV-1) [1][2][3] Company Summary - Theralase Technologies Inc. is a clinical stage pharmaceutical company focused on developing light, radiation, sound, and drug-activated therapeutics for treating various diseases, including cancer and viral infections [1][8] - The company is advancing Ruvidar® into clinical development, with plans for a Phase I/II adaptive clinical study in 2026 to assess its safety and efficacy in treating cold sore lesions [1][6] Research Findings - The latest research published in MDPI - Viruses indicates that Ruvidar® significantly inhibits HSV-1 replication post-infection, unlike Acyclovir® and Metformin®, which show little effect once infection is established [2][3] - Ruvidar® has demonstrated effectiveness against Acyclovir®-resistant HSV-1 mutants, highlighting its potential as a next-generation antiviral therapy [3][4] - The combination of Ruvidar® with Acyclovir® proved to be more effective than either treatment alone, suggesting potential for combinational therapies [4][6] Market Context - The global HSV treatment market was estimated at $2.8 billion in 2024 and is projected to grow to $4.7 billion by 2033, indicating a significant opportunity for effective antiviral treatments like Ruvidar® [8]

Core Insights - The ongoing mpox outbreak is a significant global health threat, necessitating increased therapeutic research and innovation [1][3] - Emergent BioSolutions has published a comprehensive review on brincidofovir, highlighting its investigational use for treating mpox infections [1][5] Company Overview - Emergent BioSolutions is focused on developing protective solutions against public health threats, including mpox, and has over 25 years of experience in this field [6] Research and Development - Brincidofovir is being evaluated in a double-blind, placebo-controlled clinical trial (MOSA) in Africa, initiated in January 2025, in partnership with Africa CDC and PANTHER [4] - The trial aims to assess the safety and efficacy of brincidofovir for mpox patients, with initial funding from Horizon Europe and Africa CDC [4] Public Health Context - The World Health Organization declared the current mpox outbreak a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, marking the second such declaration in two years [3] - The U.S. Centers for Disease Control and Prevention has reported a surge in mpox cases globally [3]

Core Insights - Traws Pharma is advancing two investigational antiviral therapies: tivoxavir marboxil (TXM) for bird flu and seasonal flu, and ratutrelvir for COVID-19, including Long COVID [2][3][4] - The company aims to accelerate the approval process for these therapies through regulatory interactions, including a briefing submitted to the FDA for TXM [3][4] - Financial results indicate a net income of $21.5 million for Q1 2025, primarily due to a change in fair value of warrant liability, contrasting with a net loss of $5.0 million in Q1 2024 [6][9] Product Development - **Tivoxavir Marboxil (TXM)**: - A single-dose investigational CAP-dependent endonuclease inhibitor targeting H5N1 bird flu and seasonal flu, with a multi-billion dollar market opportunity [4][12] - Recent studies show significant antiviral activity, including reduced viral burden in animal models [4][10] - Preparations for FDA discussions regarding accelerated approval are ongoing [10] - **Ratutrelvir**: - An investigational oral Main protease inhibitor for acute COVID treatment, with potential to prevent COVID rebound and Long COVID [5][10] - Preclinical studies indicate potent suppression of resistant virus and favorable pharmacokinetic profiles [10][13] Financial Overview - As of March 31, 2025, Traws Pharma had approximately $15.9 million in cash and equivalents, down from $21.3 million at the end of 2024, sufficient to support operations into Q1 2026 [6][21] - Revenue for Q1 2025 was $57,000, slightly up from $56,000 in Q1 2024 [6][24] - R&D expenses increased to $2.5 million in Q1 2025 from $1.9 million in Q1 2024, reflecting heightened investment in virology programs [7][24] - General and administrative expenses decreased to $2.8 million in Q1 2025 from $3.4 million in Q1 2024 [8][24] Management Updates - Iain D. Dukes was appointed Interim CEO following the retirement of Werner Cautreels [5] - Jack Stover was named Chairman of the Board on April 15, 2025 [5]

Core Viewpoint - Traws Pharma announced positive topline results from a study of tivoxavir marboxil (TXM) as a treatment for H5N1 bird flu in non-human primates, indicating its potential as a novel therapy for respiratory viral diseases [1][3][4]. Group 1: Study Results - The study involved ten non-human primates, with TXM administered as a single dose equivalent to 480 mg for humans, showing significant reduction in lung viremia and prevention of weight loss [2][5]. - TXM-treated animals had lung viremia levels consistently below the quantitation limit of 2X10^3 infectious particles per ml, while control animals reached levels as high as 1X10^7 infectious particles per ml [5]. - Control animals lost an average of 4.2% of their body weight over ten days post-challenge, whereas TXM-treated animals maintained stable or slightly increased body weight (p<0.004) [5]. Group 2: Regulatory Path and Future Plans - The company plans to meet with the FDA in the first half of 2025 to discuss the regulatory path for TXM, including the potential for accelerated approval under the "Animal Rule" [3][4]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on TXM and discuss next steps towards approval [4][5]. Group 3: Broader Implications - The ongoing threat of bird flu, particularly with reports of mutations increasing pandemic risk, underscores the importance of developing effective antiviral treatments like TXM [3][6]. - TXM has shown consistent therapeutic effects across multiple animal models, including ferrets and mice, reinforcing its potential as a treatment for both bird flu and seasonal influenza [5][6][12].