StockWatch
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Biotechnology: Pharmaceutical Preparations
Quarterly ResultMay 7, 2026, 06:03 AM

Gyre Therapeutics Q1 Revenue $22.5M; Acquires Cullgen; F351 NDA Submitted

AI Summary

Gyre Therapeutics reported Q1 2026 revenue of $22.5 million and a GAAP basic EPS of $(0.10), with a net loss of $9.9 million compared to a net income of $3.7 million in Q1 2025. The company affirmed its full-year 2026 revenue guidance of $100.5 million to $111.0 million. Key strategic developments include the submission of an NDA for F351 (hydronidone) for CHB-associated liver fibrosis to China’s CDE in March 2026, which received priority review. Additionally, Gyre completed the acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding its pipeline into inflammatory diseases and cancers. The first patient was also enrolled in a Phase 2/3 trial for ETUARY™ for radiation-induced lung injury.

Key Highlights

  • Completed acquisition of Cullgen in an approximately $300 million all-stock transaction.
  • Submitted NDA for F351 (hydronidone) to China's CDE in March 2026, granted priority review.
  • Q1 2026 revenue was $22.5 million, a 2% increase compared to Q1 2025.
  • Q1 2026 GAAP basic EPS was $(0.10).
  • Affirmed full-year 2026 revenue guidance of $100.5 million to $111.0 million.
  • Net loss for Q1 2026 was $9.9 million, compared to net income of $3.7 million in Q1 2025.
  • ETUARY™ sales for Q1 2026 were $21.0 million, a 3% decrease year-over-year.
  • Cash and cash equivalents totaled $79.2 million as of March 31, 2026.