Traws Pharma Stock Price, News & Analysis

Traws Pharma (NASDAQ: TRAW) announced key management changes as CEO Werner Cautreels, PhD, will retire effective March 31, 2025, following the company's Annual Report filing. Executive Board Chairman Iain D. Dukes, D Phil, will step in as Interim CEO while maintaining his Chairman position.

Dr. Cautreels will remain on the Board of Directors and transition to a consulting role as special advisor for the next year. Under his leadership, the company completed the merger with Trawsfynydd to form Traws Pharma, advancing two clinical-stage antiviral candidates for bird flu and COVID.

The company will hold an Investor Update call on March 31, 2025, at 10:00 AM ET to review pipeline progress. Traws Pharma focuses on developing novel therapies targeting respiratory viral diseases through oral small molecule antivirals.

Traws Pharma (NASDAQ: TRAW) has announced a virtual investor event scheduled for March 31, 2025, at 10:00 AM ET to discuss their key product candidates. The event will feature presentations from former CDC Director Dr. Robert R. Redfield, now Traws' Chief Medical Officer, and Chief Science Officer Dr. C. David Pauza.

The focus will be on two main drug candidates:

• Tivoxavir Marboxil: A single-dose, CAP-dependent endonuclease inhibitor targeting Bird Flu (H5N1)
• Ratutrelvir: A main protease inhibitor for COVID-19, designed to be used without ritonavir

The presentation will cover preclinical proof-of-concept and Phase 1 study data recently presented at ICAR 2025, the public health implications of H5N1 bird flu, and strategies to address COVID-19 clinical rebound and long COVID risks. The event will conclude with a Q&A session.

Traws Pharma (NASDAQ: TRAW) presented positive data for its COVID-19 treatment candidate ratutrelvir at ICAR 2025 in Las Vegas. The drug, designed as a main protease inhibitor, shows promising advantages over current treatments:

Key findings from preclinical and Phase 1 data indicate that ratutrelvir:

• Can be used without ritonavir (a boosting agent), reducing drug interaction risks
• Effectively suppresses 18 different SARS-CoV-2 strains, including nirmatrelvir-resistant and Omicron variants
• Maintains blood levels within therapeutic window at 600 mg/day for 10 days
• Shows excellent safety and tolerability in Phase 1 trials
• Maintains drug levels above EC90 for 2 days after treatment ends

The company is preparing for FDA interactions and Phase 2 studies, with an upcoming Investor Event scheduled for March 31, 2025.

Traws Pharma (NASDAQ: TRAW) announced positive topline results for their antiviral bird flu treatment, tivoxavir marboxil (TXM), in non-human primates. The study demonstrated that a single dose of TXM significantly reduced lung viremia and prevented weight loss in H5N1 bird flu models.

Key findings include:

• TXM-treated animals showed lung virus levels below 2X103 infectious particles/ml, compared to control group levels of up to 1X107
• Control group lost 4.2% body weight over 10 days, while TXM-treated subjects maintained or gained weight
• Results consistent with previous positive outcomes in ferret and mice studies

The company plans to meet with FDA in H1 2025 to discuss potential accelerated approval through the 'Animal Rule' pathway, supported by safety data from Phase I studies in healthy volunteers completed in January 2025. An Investor Event is scheduled for March 31, 2025, to present TXM data and outline next steps.

Traws Pharma (NASDAQ: TRAW) presented positive data for its bird flu drug candidate Tivoxavir Marboxil (TXM) at ICAR 2025 in Las Vegas. The data showcased TXM's potential as an effective bird flu treatment, demonstrating:

- 100% survival rate in rodent challenge models with significant reductions in lung viremia
- Potent suppression of influenza A, B, and C viruses, including baloxavir resistant strains
- Sub-nanomolar potency against H5N1/influenza A virus
- Phase 1 results showing single-dose maintenance of plasma levels at EC90 for ~3 weeks with good tolerability

The company plans to meet with the FDA to discuss potential accelerated approval pathways. A full dataset will be presented during an Investor Call on March 31, 2025.

Traws Pharma (NASDAQ: TRAW) has announced positive topline results from testing their antiviral candidate, tivoxavir marboxil, in ferrets infected with H5N1 bird flu. The single-dose treatment demonstrated disease suppression and reduced viral burden in lungs, consistent with previous December 2024 murine model results.

The study utilized the A/Texas/37/2024 H5N1 virus strain isolated from a Texas dairy worker. The ferret model, widely accepted for human influenza studies, showed increased survival rates and lower viral presence in lungs and nasal tissues.

The company plans to conduct additional testing in non-human primates, with data expected in Q1 2025. Traws Pharma aims to discuss accelerated approval with the FDA under the 'Animal Rule' and will host a Virtual Investor Update on March 31, 2025, to review the bird flu program in detail.

Traws Pharma (NASDAQ: TRAW) has successfully regained compliance with Nasdaq's minimum stockholders' equity requirement (Rule 5550(b)(1)), ensuring continued listing on The NASDAQ Capital Market. The compliance was achieved following a $20 million gross proceeds offering completed on December 30, 2024.

The company will remain under mandatory panel monitoring through February 25, 2026. During this period, if Traws falls below the $2.5 million stockholders' equity requirement, it would face delisting without a cure period, though with the option to request a new hearing.

Traws, a clinical-stage biopharmaceutical company, is developing oral small molecules for respiratory viral diseases. Their lead program for bird flu/influenza has recently completed a Phase 1 trial, with ongoing laboratory studies.

Traws Pharma (NASDAQ: TRAW) has announced the completion of Phase I clinical studies for tivoxavir marboxil, their investigational one-dose therapy for H5N1 bird flu treatment and prevention. The randomized, double-blind, placebo-controlled study evaluated safety, tolerability, and pharmacokinetics in healthy adult volunteers across four dose levels.

The topline results showed no significant treatment-related adverse events, and pharmacokinetic data supported dosing for both therapeutic use and prevention. Preclinical studies demonstrated that tivoxavir marboxil effectively inhibited drug-resistant influenza viruses and highly pathogenic bird flu viruses both in vitro and in vivo.

The company views these results as supportive of accelerated development in response to growing bird flu threats, particularly following the first U.S. death and spread into commercial poultry farms. The combined clinical and animal model data will guide upcoming regulatory meetings.

Expert Systems and Traws Pharma (NASDAQ: TRAW) have announced significant progress in their H5N1 bird flu antiviral program. Their investigational drug, Tivoxavir Marboxil, has demonstrated promising results as a single-dose treatment for avian influenza. The oral cap-dependent endonuclease inhibitor has shown broad-spectrum efficacy against various flu strains in preclinical studies.

In Phase 1 clinical trials, the drug showed no treatment-related adverse events and maintained effective plasma levels for over 23 days with a single dose. Dr. Robert R. Redfield, Chief Medical Officer for Traws Pharma and former CDC Director, emphasized the increasing risk of bird flu adaptation to humans and potential pandemic spread.

The company plans to initiate Phase 2 efficacy studies in the first half of 2025. The development leverages Expert Systems' hybrid AI-enabled drug discovery platform, combining artificial intelligence with human expertise for expedited therapy development.