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SAN DIEGO - Gyre Therapeutics (NASDAQ:GYRE), a biotechnology firm specializing in organ fibrosis treatments, has recently published the protocol for its Phase 3 trial on hydronidone, a drug intended for liver fibrosis in chronic hepatitis B patients. According to InvestingPro data, the company maintains a FAIR financial health rating, with liquid assets exceeding short-term obligations by more than 3 times. The trial protocol, now available in the Journal of Clinical and Translational Hepatology, details the methodology for the pivotal study, which completed patient enrollment in October 2024.
The double-blind, placebo-controlled trial enrolled 248 patients across 44 clinical research hospitals in China. Participants were randomized to receive either the investigational drug F351 or a placebo, alongside standard antiviral therapy for hepatitis B. The primary measure for the trial’s success is a reduction in liver fibrosis, assessed by the Ishak Scoring System after 52 weeks of treatment.
F351, also known as hydronidone, is a structural analogue of Pirfenidone, which is an existing treatment for idiopathic pulmonary fibrosis. F351’s dual action mechanism aims to inhibit both p38γ kinase activity and TGF-β1-driven collagen production, which are key factors in the development of liver fibrosis. The drug specifically targets hepatic stellate cells, implicated in the progression of fibrosis.
Preclinical studies have shown F351’s potential in reducing fibrosis, with promising anti-proliferative and anti-fibrotic effects on hepatic stellate cells demonstrated in multiple animal models. These findings support the drug’s progression into late-stage development.
In March 2021, the National Medical Products Administration of China granted F351 a Breakthrough Therapy designation. Topline results from the Phase 3 trial are expected in the second quarter of 2025.
Gyre Therapeutics’ parent company, Gyre Pharmaceuticals, has been a key player in the market for organ fibrosis treatments. Its flagship product, ETUARY (Pirfenidone capsule), was the first approved treatment for idiopathic pulmonary fibrosis in China and has maintained significant market share, with 2024 net sales reaching $105.8 million. The company boasts an impressive gross profit margin of 96%, though InvestingPro analysis indicates the stock is currently trading near its 52-week low, with 10+ additional insights available to subscribers.
This press release statement contains forward-looking statements, which involve risks and uncertainties. These include Gyre’s ability to execute clinical development strategies and the potential for clinical trial results to differ materially from those anticipated. The company cautions that forward-looking statements are not guarantees of future performance and actual results may vary. Investors should note that InvestingPro analysis suggests the stock is currently undervalued, with the next earnings report scheduled for May 8, 2025. Get comprehensive valuation metrics and more with an InvestingPro subscription.
In other recent news, Gyre Therapeutics reported fourth-quarter revenue of $27.87 million, slightly up from $27.1 million in the same period the previous year. The company also released its full-year 2025 revenue guidance, which is expected to be between $118 million and $128 million. This projection indicates a growth of 11.3% to 20.8% over 2024, but falls short of the $135.7 million that analysts had anticipated. Gyre’s 2025 outlook includes the commercial launches of two new products: nintedanib for idiopathic pulmonary fibrosis and avatrombopag for chronic liver disease-associated thrombocytopenia. These products are expected to be introduced in China this year, complementing the company’s existing ETUARY franchise. CEO Han Ying expressed confidence in successfully launching and expanding these products in the PRC, citing the company’s proven track record and extensive sales and marketing platform. The company concluded 2024 with $51.2 million in cash and investments.
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