Core Insights - Traws Pharma is advancing its antiviral pipeline with multiple regulatory submissions for tivoxavir marboxil (TXM) and ratutrelvir, targeting seasonal and bird flu as well as COVID-19 [1][2][3] Group 1: Tivoxavir Marboxil (TXM) - A Phase 2 study protocol has been submitted to evaluate TXM in patients with seasonal influenza and H5N1 bird flu, aiming for a non-inferiority comparison with XOFLUZA® [2][3] - The study will enroll subjects in Australia and Southeast Asia, regions with high rates of human bird flu infections, to assess TXM's efficacy [2][3] - Traws Pharma is in discussions with the FDA regarding accelerated approval pathways for TXM under the Animal Rule [4][3] - TXM is designed as a single-dose oral treatment with demonstrated in vitro activity against various influenza strains, including H5N1 [8] Group 2: Ratutrelvir - A separate Phase 2 study protocol has been submitted for ratutrelvir, a protease inhibitor for newly diagnosed COVID patients, comparing it to PAXLOVID [4][6] - The study will evaluate a 10-day treatment regimen for ratutrelvir against the 5-day regimen for PAXLOVID, focusing on efficacy, safety, disease rebound, and Long COVID incidence [4][5] - Ratutrelvir is positioned as a ritonavir-independent treatment, potentially broadening its use among patients ineligible for PAXLOVID [9][6] Group 3: Market Potential - The seasonal influenza antiviral market represents a multi-billion dollar opportunity, driven by global health organizations and potential pandemic outbreaks [8] - The COVID-19 treatment market also presents significant potential, with ratutrelvir aiming to address gaps in existing therapies [9]

NEWTOWN, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA, the Agency). The FDA provided feedback on development paths fo ...

FDA briefing document submitted April 24, 2025 in support of a meeting to align on pathway for tivoxavir marboxil (TXM, bird flu/seasonal flu) including potential for accelerated approval utilizing the "Animal Rule" Additional briefing document in support of a meeting to align on ratutrelvir for COVID - including Long COVID - to be submitted to regulatory authorities in Q2 2025 Cash runway to support planned operations into Q1 2026 NEWTOWN, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: T ...

Core Insights - Traws Pharma is advancing tivoxavir marboxil (TXM) as a single-dose therapeutic for bird flu, supported by strong antiviral activity in animal models and positive Phase 1 clinical data [1][2][3] - The company is in discussions with the FDA regarding an accelerated approval pathway under the "Animal Rule" [1][2] - Traws Pharma has a cash runway that is expected to support operations into Q1 2026, following a successful financing round that raised $20 million [1][12] Recent Developments - Traws Pharma has declared bird flu as its top priority, with ongoing concerns about farm infections and mutated viruses posing a pandemic risk [2] - Positive preclinical data for TXM has been demonstrated in three validated flu models, showing robust antiviral activity [2][6][8] - The company completed Phase 1 studies for TXM, indicating its potential as a single-dose oral treatment for H5N1 bird flu [9] Financial Performance - As of December 31, 2024, Traws Pharma reported cash and cash equivalents of approximately $21.3 million, an increase from $20.8 million in 2023 [12] - Research and development expenses for 2024 totaled $12.8 million, up from $11.4 million in 2023, primarily due to clinical and preclinical trials [13] - The net loss for 2024 was $166.5 million, significantly higher than the $18.9 million loss in 2023, largely due to acquired in-process research and development expenses [15][28] Product Pipeline - Traws Pharma's lead product candidate, TXM, is designed to be a single-dose treatment for bird flu and has shown potent in vitro activity against various influenza strains [17][18] - The company is also developing ratutrelvir, a COVID-19 treatment that does not require co-administration with ritonavir, potentially broadening its patient use [19][21] - Upcoming milestones include finalizing the development plan for TXM and submitting a pre-IND meeting request for ratutrelvir to engage with the FDA [7][10]

Core Insights - Traws Pharma is advancing tivoxavir marboxil (TXM) as a single-dose therapeutic for bird flu, supported by strong antiviral activity in animal models and positive Phase 1 clinical data [1][2][17] - The company is in discussions with the FDA regarding an accelerated approval pathway under the "Animal Rule" [1][2][7] - Traws Pharma has sufficient cash reserves, approximately $21.3 million, to support operations into Q1 2026 [1][12] Recent Developments - Traws Pharma reported positive topline results from studies of TXM in non-human primates and ferrets, indicating its effectiveness against H5N1 bird flu [5][8] - The company completed a financing round in December 2024, raising $20 million, which has strengthened its investor base [2] - The upcoming investor call will cover public health risks related to bird flu and the regulatory strategy for TXM, as well as updates on the COVID-19 treatment candidate, ratutrelvir [3] Financial Performance - For the year ended December 31, 2024, Traws Pharma reported a net loss of $166.5 million, significantly higher than the $18.9 million loss in 2023, primarily due to acquired in-process research and development expenses [15][25] - Research and development expenses increased to $12.8 million from $11.4 million in the previous year, reflecting ongoing clinical trials [13] - General and administrative expenses rose to $12.3 million from $9.1 million, largely due to increased consulting fees [14] Market Opportunity - The market for seasonal influenza treatments is estimated to be a multi-billion dollar opportunity, with potential growth from pandemic threats like H5N1 bird flu [17][18] - Ratutrelvir, the company's COVID-19 candidate, is positioned to address the need for improved therapies to mitigate clinical rebound and long COVID risks [19]

Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird FluRatutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ:TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respir ...

Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird FluRatutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respi ...

Core Viewpoint - Traws Pharma, Inc. has presented positive data for ratutrelvir, a main protease inhibitor, as a potential treatment for COVID-19, highlighting its advantages over current therapies, particularly the lack of need for co-administration with ritonavir [1][2][4]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 [9][10]. - The company aims to create safe antiviral agents with simple dosing regimens to address critical health threats [9]. Product Development - Ratutrelvir is designed to be an oral, small molecule Mpro (3CL protease) inhibitor that can be used without ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [7][10]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains therapeutic blood levels significantly above the effective concentration (EC50) and does not require a metabolism inhibitor [5][7]. Clinical Data - Data from Phase 1 studies demonstrate excellent safety and tolerability for ratutrelvir, with a selected Phase 2 dosing regimen of 600 mg/day for 10 days showing promising pharmacokinetics [6][7]. - Laboratory studies confirm that ratutrelvir effectively suppresses replication of various SARS-CoV-2 strains, including Omicron variants, and maintains blood plasma levels above the EC90 [5][6]. Future Plans - Traws Pharma is preparing to engage with the FDA to discuss the path forward for ratutrelvir and plans to initiate Phase 2 studies [4][6]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on ratutrelvir [4][6].

Core Viewpoint - Traws Pharma, Inc. has presented positive data for ratutrelvir, a main protease inhibitor, as a potential treatment for COVID-19, highlighting its advantages over current therapies, particularly the lack of need for co-administration with ritonavir [1][2][4]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including COVID-19 [9][10]. - The company aims to create safe antiviral agents with simple dosing regimens and is committed to accelerated clinical trial strategies [9]. Product Development - Ratutrelvir is designed to be an oral, small molecule Mpro inhibitor that can be used without ritonavir, potentially avoiding drug-drug interactions and expanding patient eligibility [7][10]. - Preclinical and Phase 1 studies indicate that ratutrelvir maintains blood plasma levels approximately 13 times above the EC50, which may reduce the likelihood of clinical rebound and long COVID [7][6]. Clinical Data - Data presented at the International Conference for Antiviral Research (ICAR 2025) demonstrated that ratutrelvir effectively suppressed replication of 18 different SARS-CoV-2 strains, including Omicron variants [2][5]. - Phase 1 results showed excellent safety and tolerability, with a selected Phase 2 dosing regimen of 600 mg/day for 10 days [3][6]. Future Plans - The company is preparing to engage with the FDA to discuss the path forward for ratutrelvir and plans to initiate Phase 2 studies [4][2]. - An Investor Event is scheduled for March 31, 2025, to present an overview of preclinical and human data on ratutrelvir [4][2].

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].