Gyre Therapeutics (GYRE) said its Hydronidone compound to treat liver fibrosis in patients with chronic hepatitis B met the primary endpoint in the phase 3 trial in China.
The 52-week trial revealed that almost 53% of patients receiving Hydronidone achieved 1-stage regression in liver fibrosis versus placebo, Gyre said Thursday in a statement.
The drug was well tolerated with no discontinuations due to adverse events, the company said.
Gyre plans to present full trial results at a medical congress and file a new drug application with China's National Medical Products Administration in Q3.
In a separate statement, Gyre announced a proposed underwritten public share offering with proceeds to advance its Phase 2 clinical trial of F351 in the US to treat liver fibrosis, among other things.
Gyre shares fell 15% in after-hours trading.
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