Gold prices steady ahead of Fed decision; weekly weakness noted
NEWTOWN, Pa. - Traws Pharma, Inc. (NASDAQ:TRAW), a small-cap pharmaceutical company currently trading at $1.43, has submitted multiple regulatory filings to advance clinical trials for its antiviral drug candidates, according to a press release statement issued Monday. According to InvestingPro analysis, the company appears undervalued despite its shares falling over 87% in the past year.
The company has submitted a Phase 2 protocol to the Human Research Ethics Committee (HREC) to evaluate tivoxavir marboxil (TXM) in patients with seasonal and H5N1 bird flu in Australia and Southeast Asia. The study aims to compare TXM to Xofluza in seasonal influenza patients, with a separate arm studying TXM in bird flu patients. While the company maintains a healthy current ratio of 1.81 and holds more cash than debt on its balance sheet, InvestingPro data shows its financial health score remains weak, highlighting the importance of successful clinical trials for future growth.
Traws has also submitted briefing documents to the FDA requesting a Type D meeting to discuss potential pathways for accelerated approval of TXM for bird flu treatment.
Additionally, the company submitted a Phase 2 protocol to HREC for ratutrelvir, its COVID-19 treatment candidate. The proposed study will compare a 10-day ratutrelvir regimen to the standard 5-day Paxlovid treatment in newly diagnosed COVID-19 patients, with endpoints measuring efficacy, safety, disease rebound rates, and Long COVID incidence.
"Today’s announcements demonstrate our commitment to rapidly advance our antiviral portfolio," said Iain D. Dukes, Interim Chief Executive Officer for Traws Pharma. With analysts setting a $6.00 price target and the company’s next earnings report due August 12, 2025, investors seeking detailed analysis can access the comprehensive Pro Research Report available on InvestingPro, which covers this and 1,400+ other US stocks with actionable intelligence and expert insights.
According to the company, TXM is an investigational oral CAP-dependent endonuclease inhibitor designed as a single-dose treatment for influenza. Preclinical studies showed activity against multiple influenza strains, including H5N1.
Ratutrelvir is described as an oral Mpro inhibitor for COVID-19 that, unlike Paxlovid, does not require co-administration with ritonavir, potentially avoiding drug-drug interactions and enabling wider patient use.
The company is also seeking development and commercialization partners for its clinical oncology programs.
In other recent news, Traws Pharma, Inc. has received guidance from the U.S. Food and Drug Administration (FDA) on the development of its investigational flu drug, tivoxavir marboxil, for bird flu and seasonal influenza. This feedback outlines potential approval paths, including the Animal Rule, which could expedite the drug’s availability for pandemic preparedness. In a separate development, Traws Pharma has entered into an employment agreement with Iain Dukes as its Interim CEO, with compensation details disclosed in an SEC filing. Additionally, the company has announced a potential $50 million stock offering through an At The Market Offering Agreement with Citizens JMP Securities, LLC. This move is intended to raise capital in a flexible manner, as needed. Furthermore, during its Q1 2025 earnings call, Traws Pharma reported a robust cash position of $21.3 million, expected to sustain operations into early 2026. The company is actively pursuing market opportunities for its antiviral treatments, particularly for bird flu and COVID-19. These recent developments reflect Traws Pharma’s strategic efforts to advance its pipeline and strengthen its financial position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.