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Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of Ratutrelvir in PAXLOVID®-Eligible and Ineligible COVID-19 Patients

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IND filing of tivoxavir marboxil represents final step for formal consideration by the Center for th...

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Traws Pharma’s recent IND filing for tivoxavir marboxil (TXM) highlights its potential role in the U.S. national stockpile for influenza. In parallel, ratutrelvir demonstrates notable advantages over PAXLOVID in treating COVID-19, accentuating TRAW's prospects in both influenza and COVID-19 markets.

Sentiment Rationale

The IND filing and promising clinical trial results considerably enhance Traws Pharma's growth prospects, potentially leading to a strong price increase following FDA approval, similar to historical cases of biotech firms advancing successful IND applications.

Trading Thesis

Buy TRAW in anticipation of positive regulatory and clinical advancements within 12 months.

Market-Moving

  • Successful FDA approval for TXM could drive significant revenue for TRAW.
  • Ratutrelvir's interim results may validate its competitive position over current treatments.
  • Inclusion of TXM in national stockpile would enhance TRAW's credibility and market potential.
  • Effective treatments could unlock multi-billion dollar market opportunities for TRAW.

Key Facts

  • Traws Pharma files IND application for tivoxavir marboxil with the FDA.
  • Ratutrelvir shows superior efficacy and safety compared to PAXLOVID in interim analysis.
  • TXM aims for inclusion in the national stockpile for influenza treatment.
  • Full enrollment in clinical trials for ratutrelvir is set for January 2026.
  • Potential market opportunities for TXM and ratutrelvir worth billions.

Companies Mentioned

  • Pfizer Inc. (PFE): Competitor in the COVID treatment market with PAXLOVID.
  • Sanofi (SNY): Engaged in respiratory viral disease treatments impacting market dynamics.

Corporate Developments

This news falls into 'Corporate Developments' as Traws Pharma is advancing its pipeline of antiviral therapies critical for addressing respiratory diseases. The focus on FDA interactions and product filings signals important strategic moves that could shape the company’s market positioning.

Traws Pharma Files IND Application for Tivoxavir Marboxil and Updates on Ratutrelvir Clinical Study

NEWTOWN, Pa., Jan. 13, 2026 (GLOBE NEWSWIRE) – Traws Pharma, Inc. (NASDAQ: TRAW), a leading clinical-stage biopharmaceutical company focused on innovative therapies for respiratory viral diseases, has recently filed a U.S. Investigational New Drug (IND) application with the FDA for tivoxavir marboxil (TXM). This significant step aims to secure formal consideration for TXM's inclusion in the strategic national stockpile as a treatment for influenza.

Importance of the IND Filing for Tivoxavir Marboxil

Tivoxavir marboxil is designed as a single oral tablet that functions as a CAP-dependent endonuclease inhibitor. The filing of the IND represents a critical phase for Traws Pharma, enhancing the potential for TXM to be recognized as a best-in-class treatment for influenza.

Dr. C. David Pauza, Chief Scientific Officer of Traws Pharma, stated, “This filing represents an important step towards formal consideration of TXM for influenza therapy and inclusion in the strategic national stockpile.” The unique properties of TXM as a broad pan-influenza strain therapeutic have kept the company optimistic about its future prospects in public health strategies against influenza outbreaks.

Updated Clinical Results for Ratutrelvir

In addition to the IND filing for tivoxavir marboxil, Traws Pharma has released updated interim results from its ongoing Phase 2 clinical study of ratutrelvir. This investigational drug is a ritonavir-free oral Mpro/3CL protease inhibitor being compared to PAXLOVID® in patients with mild-to-moderate COVID-19.

The interim analysis confirmed that ratutrelvir presents a differentiated clinical profile when compared to PAXLOVID®, particularly in PAXLOVID®-ineligible patients who often experience heightened risks from COVID-19.

  • Study Design: Active-controlled trial comparing ratutrelvir to PAXLOVID®.
  • Enrollment: 95% of the planned 90 patients have been enrolled.
  • Dosing: Ratutrelvir patients received 600 mg daily for 10 days; PAXLOVID® patients received a combination of nirmatrelvir and ritonavir over 5 days.

Dr. Robert R. Redfield, Chief Medical Officer at Traws Pharma, commented, “These interim data confirm that ratutrelvir may provide a meaningful benefit across a broader range of patients.” The data indicated ratutrelvir's advantage in achieving symptom resolution faster and with fewer adverse events relative to PAXLOVID®.

Key Findings from Ratutrelvir's Clinical Analysis

The interim analysis highlighted several key outcomes:

  • Time to Symptom Resolution: Ratutrelvir-treated patients experienced sustained alleviation of symptoms in an average of 12 days, compared to 14 days for PAXLOVID® (p<0.014).
  • Adverse Events: Ratutrelvir demonstrated a favorable safety profile with fewer reported adverse events than those observed in the PAXLOVID® group.
  • Viral Rebound: Notably, no COVID-19 symptom or virologic rebound events occurred among ratutrelvir patients compared to one rebound event in the PAXLOVID® group.

Future Implications

Traws Pharma anticipates completing enrollment for the ratutrelvir study by January 2026, paving the way for further validation of its efficacy and safety. The potential of ratutrelvir to treat patients ineligible for ritonavir-boosted therapies reinforces its role in addressing critical gaps in COVID-19 treatment options.

According to Dr. Iain Dukes, CEO of Traws Pharma, “The combination of early and sustained symptom improvement and a favorable tolerability profile supports ratutrelvir as a next-generation oral 3CL protease inhibitor.” This positions ratutrelvir not only as a contender in the current COVID-19 landscape but also as a promising candidate for long-COVID prevention strategies.

About Traws Pharma

Traws Pharma, Inc. (NASDAQ: TRAW) is committed to developing novel therapies to combat significant public health threats posed by respiratory viral diseases. The company's pipeline includes innovative treatments designed to offer improved efficacy and safety profiles, addressing both current and emerging health challenges.

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