Welcome to our dedicated page for Gyre Therapeutics news (Ticker: GYRE), a resource for investors and traders seeking the latest updates and insights on Gyre Therapeutics stock.
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 (GYRE) will participate in the Cantor Global Healthcare Conference and the Morgan Stanley Healthcare Conference in New York during September 2026.
The Cantor event is on September 9, 2026 at 9:45 a.m. ET, and the Morgan Stanley event is on September 16, 2026 at 1:05 p.m. ET. Both will be webcast live, with replays available on Gyre’s investor website for 30 days.
Gyre Therapeutics (Nasdaq: GYRE) reported Q2 2026 revenue of $29.1 million, down 2% from $29.7 million a year earlier, and a GAAP basic EPS of $(0.12). The company affirmed its full-year 2026 revenue guidance of $100.5–$111.0 million.
ETUARYTM sales in China rose to $28.0 million from $23.5 million, while EtorelTM and ContivaTM declined. In May 2026, China’s CDE accepted an NDA for F351 (hydronidone) for CHB‑induced liver fibrosis. On May 4, 2026, Gyre closed a $300 million all-stock acquisition of Cullgen, adding targeted protein degrader and DAC oncology/inflammation programs.
As of June 30, 2026, Gyre held $103.2 million in total cash and investments, down from $116.1 million at year-end 2025. Q2 2026 loss from operations widened to $14.4 million (vs. $2.2 million loss), and net loss was $14.3 million (vs. $2.2 million loss), driven mainly by higher R&D, including F351-related costs, and transaction expenses.
Gyre Therapeutics (Nasdaq: GYRE) announced that its Board of Directors has appointed three new members effective August 1, 2026: Chief Scientific Officer Yue Xiong, Ph.D., Maxwell (Max) Kirkby, and Claire Weston, Ph.D.
According to Gyre Therapeutics, Xiong will serve as a Class I director with a term expiring at the 2028 annual meeting, Kirkby as a Class II director with a term expiring in 2029 and membership on the Compensation Committee, and Weston as a Class III director with a term expiring in 2027 and membership on the Audit Committee. The company states these appointments enhance its scientific, clinical development, governance, and cross-border biopharmaceutical expertise as it advances a pipeline spanning fibrosis, cancer, inflammation and pain, including targeted protein degrader and degrader-antibody conjugate platforms.
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).