Gyre Therapeutics Posts Q1 $22.5M Revenue, Affirms $100.5–$111M Guidance

GYREGYRE

Gyre Therapeutics posted Q1 revenue of $22.5M with GAAP loss of $0.10 per share and affirmed 2026 revenue guidance of $100.5–$111.0M. The company completed a $300M all-stock Cullgen acquisition, submitted an NDA for F351 in China with priority review, and enrolled the first patient in an ETUARY Phase 2/3 trial.

1. First Quarter Financial Results

Gyre generated $22.5M revenue (+2% YoY) and reported a GAAP loss of $0.10 per share in Q1 2026. It reaffirmed full-year 2026 revenue guidance at $100.5M–$111.0M, supported by stable collections and a 4% increase in cash to $79.2M.

2. Commercial Product Sales

ETUARY™ led sales with $21.0M in Q1, down 3% from $21.7M a year earlier, while Etorel™ and Contiva™ contributed $0.7M and $0.8M respectively, with Contiva™ more than doubling its year-ago revenue.

3. Pipeline and Regulatory Progress

In March 2026, Gyre submitted an NDA for F351 (hydronidone) for CHB-associated liver fibrosis to China’s CDE, earning priority review status. The first patient was also enrolled in an adaptive Phase 2/3 trial of ETUARY™ for radiation-induced lung injury, including immune-related pneumonitis.

4. Cullgen Acquisition and Strategic Impact

In May 2026, Gyre closed a $300M all-stock acquisition of Cullgen, adding targeted protein degraders for inflammatory diseases and cancers. Gyre is reviewing its combined pipeline to prioritize key programs and will update its strategic direction upon completion.

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