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NEWTOWN, Pa. - Traws Pharma, Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical company with a market capitalization of $10.3 million, has announced positive data for its drug candidate ratutrelvir, suggesting its potential as a standalone treatment for COVID-19. While the company is currently unprofitable and burning through cash, InvestingPro analysis indicates expectations for profitability this year. The data, presented at the International Conference for Antiviral Research on March 20, 2025, indicates that ratutrelvir, a protease inhibitor, may not require the co-administration of ritonavir, which is currently a standard practice for enhancing the effectiveness of COVID-19 therapies.
Preclinical and Phase 1 studies have demonstrated that ratutrelvir can suppress the replication of 18 different strains of SARS-CoV-2, including the original and Omicron variants. This development comes as the company’s stock has experienced significant volatility, with shares down nearly 87% over the past year, though InvestingPro data suggests the stock is currently trading in oversold territory. Importantly, ratutrelvir maintained blood levels within the therapeutic window without the need for ritonavir, which could simplify treatment and reduce drug-drug interaction risks for patients with complex medical conditions.
Phase 1 clinical trials showed that ratutrelvir has an excellent safety profile and favorable pharmacokinetics, supporting a 10-day treatment regimen. This extended dosing period aims to optimize viral suppression and potentially decrease the rates of clinical rebound and the risk of long COVID.
Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the CDC, highlighted the drug’s design to overcome limitations of current COVID treatments. C. David Pauza, PhD, Chief Science Officer for Traws Pharma, noted the drug’s distinct drug resistance patterns compared to other treatments such as nirmatrelvir and ensitrelvir.
The company plans to engage with the FDA to discuss the path forward and initiate Phase 2 studies. An Investor Event is scheduled for March 31, 2025, to present an overview of the data on ratutrelvir and discuss potential next steps toward approval. Analysts maintain a Strong Buy recommendation with a $6 price target, significantly above current trading levels. For deeper insights into Traws Pharma’s financial health and growth prospects, including 11 additional exclusive ProTips, visit InvestingPro.
Traws Pharma focuses on developing novel therapies for respiratory viral diseases, with two antiviral programs targeting bird flu, seasonal influenza, and COVID-19. The information on ratutrelvir and its development is based on a press release statement from Traws Pharma.
In other recent news, Traws Pharma has reported significant findings from studies on its drug candidate, tivoxavir marboxil (TXM), aimed at treating bird flu. The company announced that TXM showed promising results in non-human primates, demonstrating a reduction in lung viremia and prevention of weight loss in subjects exposed to the H5N1 virus. Traws Pharma is actively seeking FDA feedback for an expedited approval pathway under the "Animal Rule," with discussions planned for the first half of 2025. Additionally, Traws Pharma presented data at the International Society for Antiviral Research, highlighting TXM’s effectiveness and safety in Phase 1 trials. In further developments, Traws Pharma has regained compliance with Nasdaq’s stockholders’ equity requirement following a successful equity financing round. The company has also amended the terms of its Series A Warrants, increasing the threshold for a change of control and revising the volatility rate used in calculations. These recent developments reflect Traws Pharma’s ongoing efforts to advance its antiviral drug programs and maintain its position on the Nasdaq Capital Market.
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