Gyre Therapeutics gets China nod for PAH drug trial By Investing.com

SAN DIEGO – Gyre Therapeutics (NASDAQ:GYRE), a biotech firm focused on anti-fibrotic treatments, has received approval from China’s drug regulator to begin clinical trials for its pulmonary arterial hypertension (PAH) medication, F230. The Center for Drug Evaluation of the National Medical Products Administration greenlighted the Investigational New Drug application, a significant step in addressing PAH, a rare and life-threatening disorder.

The company, through its subsidiary Gyre Pharmaceuticals, aims to improve patient outcomes for those suffering from PAH, a condition currently without a cure. F230 has shown promise in preclinical studies, demonstrating significant reductions in several key indicators of PAH severity, even at the lowest effective dosage.

Gyre’s CEO, Han Ying, Ph.D., emphasized the company’s commitment to advancing F230’s clinical development. The drug, a selective endothelin receptor antagonist, was initially licensed from Eisai and is part of Gyre’s diverse pipeline being developed in the People’s Republic of China. Beyond PAH, Gyre is investigating additional disease indications for F230.

Headquartered in San Diego, CA, Gyre Therapeutics is also focusing on the development of F351 (Hydronidone) for treating NASH-associated fibrosis in the U.S. The company’s strategy is informed by its experience in NASH rodent model studies and liver fibrosis clinical studies caused by chronic hepatitis B.

The announcement contains forward-looking statements regarding the potential of F230, including its therapeutic utility and clinical benefits. However, these statements are based on current plans and expectations and are subject to various risks and uncertainties that could impact the actual results and the timing of clinical trials and regulatory approvals.

The press release also outlines the company’s financial position and capital resource sufficiency, indicating a need for additional capital to advance its clinical development strategies. Investors are cautioned that positive clinical trial results may not necessarily predict future outcomes and that economic and industrial conditions can affect the company’s progress. This news is based on a press release statement from Gyre Therapeutics.

InvestingPro Insights

As Gyre Therapeutics (NASDAQ:GYRE) gears up to initiate clinical trials in China for its promising PAH drug F230, the company’s financial metrics and stock performance provide additional context for investors monitoring the firm’s progress. According to recent data from InvestingPro, Gyre’s market capitalization stands at a solid $890.16 million USD. Despite the challenges faced in the biotech industry, Gyre’s revenue over the last twelve months as of Q1 2024 has grown by 10.75%, showcasing the company’s ability to expand its financial base amidst its clinical developments.

InvestingPro Tips indicate that Gyre’s stock has experienced significant volatility recently, with the price taking notable hits over the last week and month. The company’s stock has declined by 21.09% over the past week and 36.22% over the last month. While these figures may cause concern, it’s worth noting that Gyre operates with a moderate level of debt and its liquid assets exceed short-term obligations, suggesting a degree of financial resilience.

However, investors should be aware that Gyre is currently not profitable, with a negative P/E ratio of -8.24, and is trading at a high Price / Book multiple of 15.68. These metrics underscore the high-risk, high-reward nature often associated with biotech investments. For those interested in a deeper analysis of Gyre Therapeutics, InvestingPro offers additional insights and tips. There are currently 11 more InvestingPro Tips available, which can be explored further with a subscription. Readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, enhancing their investment research tools.

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