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Gyre Therapeutics, Inc. reports commercial-stage biopharmaceutical developments tied to organ fibrosis, inflammatory diseases and cancer-focused pipeline expansion. The company generates revenue through Gyre Pharmaceuticals in China, including ETUARY® (pirfenidone) and other commercial products, while advancing Hydronidone (F351) for chronic hepatitis B-associated liver fibrosis and MASH-associated liver fibrosis.
Recurring updates include quarterly results, revenue guidance, China NMPA and CDE interactions, NDA disclosures for F351, pirfenidone indication-expansion studies in lung fibrosis, and integration of Cullgen’s targeted protein degrader and degrader antibody conjugate candidates after the completed acquisition.
Gyre Therapeutics (Nasdaq: GYRE) announced that China’s NMPA Center for Drug Evaluation has accepted its New Drug Application for F351 (hydronidone) to treat chronic hepatitis B (CHB)-induced liver fibrosis.
This is the company’s second major product NDA and the first submission for F351, previously granted priority review.
Gyre Therapeutics (Nasdaq: GYRE) reported Q1 2026 revenue of $22.5M and GAAP basic EPS $(0.10). Full‑year 2026 revenue guidance of $100.5M–$111.0M was affirmed. The company completed an ~$300M all‑stock acquisition of Cullgen and submitted an NDA for F351 to China’s CDE.
Cash and equivalents totaled $79.2M as of March 31, 2026. R&D and operating expenses rose amid clinical and integration investments.
Gyre Therapeutics (Nasdaq: GYRE) completed its acquisition of Cullgen in an all-stock transaction valued at approximately $300 million, creating a U.S.- and China-based integrated biopharmaceutical company.
The combined company gains a commercial-stage product (ETUARY® in China), a lead candidate F351 with recent priority review in China, ongoing Phase 3 ETUARY enrollment, and a pipeline of TPDs and DACs.
Gyre Therapeutics (Nasdaq: GYRE) announced that China’s NMPA Center for Drug Evaluation granted priority review to the NDA for Hydronidone (F351) to treat CHB‑induced liver fibrosis on March 17, 2026. The CDE decision follows a pre‑NDA communication meeting on January 5, 2026.
Gyre plans to submit a formal NDA in the near future through its majority‑owned subsidiary, Gyre Pharmaceuticals Co., Ltd., and will work with CDE during the review.
Gyre Therapeutics (Nasdaq: GYRE) reported full-year 2025 revenue of $116.6 million, up 10.2% year-over-year, and ending cash and deposits of $75.9 million. The company provided 2026 revenue guidance of $100.5M–$111.0M and announced an agreement to acquire Cullgen for approximately $300 million. Gyre expects to submit an NDA for Hydronidone for conditional approval in China in H1 2026 and completed enrollment in a 52-week Phase 3 pirfenidone trial (272 patients).
Gyre Therapeutics (Nasdaq: GYRE) completed a Pre-NDA meeting with China’s CDE that agreed existing Phase 3 data for Hydronidone generally support a conditional approval NDA and indicated priority review eligibility, subject to formal filing and review. The Phase 3 topline showed 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52 vs 29.84% for placebo (p=0.0002).
The company expects to submit an NDA for conditional approval in the first half of 2026 and will run a confirmatory Phase 3c trial in China to evaluate liver-related clinical outcomes needed to convert conditional approval to regular approval. Hydronidone previously received Breakthrough Therapy designation from the NMPA (March 2021).
Gyre Therapeutics (Nasdaq: GYRE) reported Q3 2025 results and a business update on Nov 7, 2025. Q3 revenue was $30.6M (+20% YoY) and GAAP net income was $5.9M. Nine-month revenue totaled $79.4M and cash and deposits were $80.3M as of Sept 30, 2025 (up 57% YTD). The company revised full-year 2025 revenue guidance to $115–118M (down from $118–128M) citing delayed Etorel rollout and government procurement uncertainty. Commercial sales in Q3 included ETUARY $27.7M, Etorel $1.5M, and Contiva $1.2M. Pipeline: Hydronidone NDA interactions in China progressing with Priority Review discussions; U.S. IND timing moved to 2026. Pirfenidone Phase 3 pneumoconiosis enrollment completed (272 patients).
Gyre Therapeutics (NASDAQ: GYRE) announced completion of patient enrollment in its 52-week Phase 3 trial of Pirfenidone capsules for pneumoconiosis on Oct 15, 2025. The randomized, double-blind, placebo-controlled study enrolled 272 patients across 18 centers in China to evaluate 52 weeks of treatment for progressive pulmonary fibrosis caused by mineral dust exposure. The company noted a significant unmet medical need: no approved therapies in China specifically target fibrotic mechanisms in pneumoconiosis, which affects >450,000 surviving patients in China. The trial completion of enrollment is a key operational milestone ahead of safety and efficacy readouts.
Gyre Therapeutics (Nasdaq: GYRE) will present results from a positive Phase 3 trial of Hydronidone for treatment of liver fibrosis in chronic hepatitis B at AASLD The Liver Meeting® 2025.
The abstract was selected as a Poster of Distinction. Presentation details: Phase 3 Trial of Hydronidone for Liver Fibrosis in Chronic Hepatitis B, presenting author Prof. Lungen Lu, M.D., Session: Hepatitis B ("1187-1367"), Date: Friday, November 7, 2025, Time: 8:00 a.m.–5:00 p.m. ET, Publication Number: 1121. The meeting runs November 7–10, 2025 in Washington D.C.
Gyre Therapeutics (Nasdaq: GYRE), a commercial-stage biopharmaceutical company focused on fibrosis-first therapies, will participate in the H.C. Wainwright 27th Annual Global Investment Conference. The company's management will deliver their presentation on September 10, 2025, at 12:30 p.m. ET.
Investors can register in advance for the presentation webcast, which will be available on Gyre's website Events and Presentations page. A replay will be accessible after the live session.