Gyre Therapeutics (GYRE) announced that its lead compound, Hydronidone (F351),
met the primary endpoint in a pivotal Phase 3 trial evaluating its efficacy and
safety for the treatment of liver fibrosis in patients with chronic hepatitis B
(CHB) in China.
GYRE closed Thursday's regular trading at $11.21 up $0.84 or 8.10%. But in the after-hours trading, the stock dropped $1.71 or 15.25%.
The trial met its primary endpoint, with a statistically significant proportion of patients receiving Hydronidone achieving a 1-stage regression in liver fibrosis compared to placebo (P=0.0002). These results are consistent with the efficacy and safety outcomes observed in Gyres prior Phase 2 trial, the company said in a statement.
At Week 52, the treatment showed a statistically significant one-stage fibrosis regression compared to the placebo (52.85% vs. 29.84%, P=0.0002). Additionally, it demonstrated a favorable safety and tolerability profile, with serious adverse events occurring in 4.88% of patients versus 6.45% for placebo, and no discontinuations due to adverse events.
Gyre plans to file an NDA with Chinas NMPA in the third quarter of 2025. In parallel, the Company is actively preparing to file an investigational new drug (IND) application in the third quarter of 2025 and, subject to IND clearance, plans to initiate a Phase 2 trial in the U.S. evaluating Hydronidone for the treatment of MASH-associated fibrosis in the second half of 2025. A prior U.S. Phase 1 trial in healthy
volunteers confirmed Hydronidones tolerability and demonstrated a pharmacokinetic profile consistent with the Chinese population.
In a separe press release, Gyre Therapeutics announced the pricing of its previously announced underwritten public offering of 2.22 million shares of its common stock at a
public offering price of $9.00 per share.
In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 333,333 shares of its common stock at the public offering price, less the underwriting discounts and commissions.
The company expects gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses, will be approximately $20.0 million. The offering is expected to close on or about May
27, 2025, subject to the satisfaction of customary closing conditions.
Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis (MASH)-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes.
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