Traws Pharma Stock Price, News & Analysis

Expert Systems Inc said it continues supporting Traws Pharma (NASDAQ: TRAW) as Traws begins Phase 2 trials of Ratutrelvir (TRX01), a ritonavir-free oral antiviral for newly diagnosed COVID-19 patients.

Key disclosed facts: Phase 1 MAD showed a 600 mg daily regimen sustaining plasma levels ~13× EC50 for a 10-day course with troughs above EC90. Regulatory clearance for Phase 2 was granted in Q3 2025. The Phase 2 program includes a non-inferiority trial vs PAXLOVID and a single-arm trial in PAXLOVID-ineligible patients. Expert Systems' AI-driven modeling contributed to PK and safety optimization and predicts higher lung tissue exposure.

Traws Pharma (NASDAQ: TRAW) announced dosing of the first subject in two Phase 2 studies of ratutrelvir, a ritonavir‑free oral antiviral for newly diagnosed COVID-19 patients on Oct 14, 2025.

One trial is a non-inferiority study versus PAXLOVID® assessing safety, disease rebound and incidence of Long COVID; a second is a single-arm study in PAXLOVID®‑ineligible patients. The company expects top-line data from both trials by year-end 2025. Management highlights once-daily, single‑tablet 10‑day dosing and aims to evaluate tolerability and rates of COVID symptoms and rebound.

Traws Pharma (NASDAQ: TRAW) appointed John Leaman, MD as an independent director effective October 1, 2025, and removed the "interim" title from Iain Dukes and Charles Parker, who are now CEO and CFO, respectively. The Board highlighted Leaman's finance, M&A and corporate‑strategy experience, including roles leading IPOs and Series D financing. Management said the company is preparing to enroll subjects in Phase 2 studies of ratutrelvir, a broadly acting oral COVID antiviral designed for use without ritonavir. The move was presented as strengthening governance and execution as Traws advances clinical development.

Traws Pharma (NASDAQ: TRAW) has received HREC approval to proceed with Phase 2 studies of ratutrelvir, their ritonavir-free COVID-19 treatment. The clinical program consists of two key trials: a non-inferiority study comparing ratutrelvir to PAXLOVID®, and a single-arm trial for PAXLOVID®-ineligible patients.

The trials will evaluate safety, efficacy, disease rebound rates, and Long COVID incidence, with top-line data expected by year-end 2025. The company highlights PAXLOVID®'s strong market presence, noting $427 million in Q2 2025 sales, a 70% year-over-year increase. Ratutrelvir's potential advantages include once-daily dosing, good tolerability, and broad activity against resistant strains.

Traws Pharma (NASDAQ: TRAW) reported Q2 2025 financial results and provided updates on its antiviral programs. The company ended Q2 with $13.1 million in cash, reporting revenue of $2.7 million and a net loss of $0.9 million ($0.11 per share).

Key developments include the prioritization of ratutrelvir, a ritonavir-free protease inhibitor for COVID-19 treatment, with Phase 2 studies planned to begin soon. The company is also advancing Tivoxavir Marboxil (TXM) for influenza, focusing on stockpiling readiness with BARDA.

Management changes include Jack Stover as new Board Chairman and Charles Parker as Interim CFO. The company will evaluate ratutrelvir versus PAXLOVID® in Phase 2 trials, with results expected by year-end 2025.

Traws Pharma (NASDAQ: TRAW), a clinical-stage biopharmaceutical company focused on developing therapies for respiratory viral diseases, will host a conference call and webcast to discuss its Q2 2025 financial results on Thursday, August 14, 2025, at 8:30 AM ET.

The company will provide updates on its financial performance for the quarter ended June 30, 2025, along with recent business developments. Investors can access the call through U.S. (1-877-407-0789) or International (1-201-689-8562) dial-in numbers using Conference ID 13754425. A replay will be available on the company's website.

Traws Pharma (NASDAQ: TRAW) has announced multiple regulatory submissions advancing its antiviral pipeline. The company has submitted a Phase 2 protocol to HREC for tivoxavir marboxil (TXM) to evaluate its effectiveness against both seasonal and bird flu in the Southern Hemisphere. Additionally, briefing documents were submitted to the FDA for a Type D meeting regarding potential accelerated approval of TXM for bird flu treatment.

The company has also submitted a Phase 2 study protocol to HREC for ratutrelvir, their protease inhibitor that doesn't require ritonavir co-administration, to evaluate its effectiveness against COVID-19. This study will compare ratutrelvir to PAXLOVID® in newly diagnosed patients, with specific focus on disease rebound and Long COVID development. The study includes a separate arm for patients ineligible for PAXLOVID® treatment.

The TXM study will be conducted in Australia and Southeast Asian countries with high rates of human bird flu infections, while the ratutrelvir study will evaluate patients on a 10-day treatment regimen compared to PAXLOVID's® 5-day regimen.

Traws Pharma announced compelling clinical efficacy data for rigosertib, their legacy oncology drug, in treating RDEB SCC patients, published in the British Journal of Dermatology. The first-ever clinical trial of an experimental cancer therapeutic in this rare monogenic disease showed remarkable results with an 80% overall response rate and complete responses in 50% of evaluable patients. The drug addresses a significant unmet need in treating cutaneous SCC in RDEB patients, where no approved therapies exist and current treatments show limited efficacy. Traws Pharma is actively seeking development and commercialization partners to advance rigosertib towards approval.

Traws Pharma (NASDAQ: TRAW) has received FDA feedback regarding development paths for tivoxavir marboxil (TXM) approval for both bird flu and seasonal flu treatment. The FDA's guidance includes the potential use of the Animal Rule pathway and the possibility of conducting a combined clinical study for both flu types. The company is pursuing discussions with BARDA for potential stockpiling of TXM for pandemic preparedness, particularly given the historical 50% mortality rate associated with H5N1 virus outbreaks. Traws plans to request a Type D meeting with the FDA to specify next steps and will engage with international regulatory agencies. The company reports positive results from three animal models of bird flu, supporting TXM's potential effectiveness.