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NEWTOWN, Pa. - Traws Pharma, Inc. (NASDAQ: TRAW), a biopharmaceutical company focused on respiratory viral diseases with a market capitalization of $7.29 million, has received guidance from the U.S. Food and Drug Administration (FDA) regarding the development of its investigational drug, tivoxavir marboxil (TXM), for the treatment of bird flu and seasonal influenza. According to InvestingPro analysis, the company appears undervalued at its current price of $1.31, with analysts setting a target price of $6. The FDA’s feedback, based on a Type B pre-Investigational New Drug Application meeting, outlines potential approval paths, including the use of the Animal Rule for circumstances where human trials are not feasible.
Chief Science Officer C. David Pauza, PhD, expressed optimism about the development of TXM following positive therapeutic effects observed in three animal models of bird flu. The company aims to expedite TXM for stockpiling and pandemic preparedness, in alignment with the urgency necessitated by high mortality rates historically associated with H5N1 virus outbreaks.
Interim CEO Iain Dukes, MA DPhil, reinforced the company’s commitment to progressing TXM’s availability for pandemic outbreaks. Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) and plans to engage with international regulatory agencies for similar purposes.
TXM, a CAP-dependent endonuclease inhibitor, has shown potent activity against various influenza strains in preclinical studies and is designed for single-dose administration. Its efficacy against H5N1 bird flu and potential in the seasonal flu market, which is estimated to be a multi-billion dollar opportunity, has been emphasized by the company. InvestingPro data reveals the company maintains a healthy current ratio of 1.81 and holds more cash than debt on its balance sheet, providing financial flexibility for drug development.
The company’s broader pipeline includes other investigational oral small molecule antiviral agents targeting difficult-to-treat virus strains, such as COVID-19/Long COVID. Traws Pharma is preparing for a Type D meeting with the FDA to further specify the next steps in TXM’s development.
This news is based on a press release statement from Traws Pharma, Inc. The company’s forward-looking statements involve risks and uncertainties, and there is no assurance that the development of tivoxavir marboxil will proceed as planned. The company’s progress and potential regulatory approval are subject to the outcomes of clinical trials and interactions with regulatory authorities, including the FDA and BARDA. While the company reported an EBITDA of -$24.89 million in the last twelve months, InvestingPro analysts predict profitability this year. For deeper insights into Traws Pharma’s financial health and growth prospects, access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Traws Pharma has announced several key developments. The company recently reported a strong cash position with $21.3 million in cash and cash equivalents as of December 31, expected to sustain operations into the first quarter of 2026. Additionally, Traws Pharma has entered an At The Market Offering Agreement with Citizens JMP Securities, allowing for the potential sale of up to $50 million in common stock. This move is part of a strategy to raise capital flexibly as needed.
In leadership changes, Iain Dukes has been appointed as the Interim CEO, effective April 1, 2025, with a base salary of $610,000 and potential bonuses. Dukes, who stepped down as Chairman of the Board, will continue as a board member, with Jack Stover succeeding him as Chairman. On the product development front, Traws Pharma is preparing for a pre-IND meeting with the FDA for its antiviral candidates, focusing on bird flu and COVID-19 treatments.
The company highlighted promising updates in its antiviral drug pipeline during its Q1 2025 earnings call, which also noted the potential market opportunities for these treatments. These developments come amid significant shifts in the pharmaceutical industry, with investors closely watching for strategic realignments.
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