Gyre Therapeutics Reports Third Quarter 2025 and Year-to-Date Financial Results and Provides Business Update

Net income of $5.9 million and $11.2 million for the three and nine months ended September 30, 2025, respectively  Full-year revenue guidance revised to $115-118 million (from $118 - $128 million previously) due to delayed Etorel® (Nintedanib) rollout and government procurement-related uncertainty Q3 2025 vs Q3 2024 Highlights Quarterly revenue of $30.6 million, up 20% year-over-year, driven by ETUARY® growth and contributions from sales of Etorel® and Contiva®. GAAP net income doubled to $5.9 million and adjusted net income rose to $8.8 million, reflecting commercial execution and disciplined cost control.

GlobeNewsWire • Nov 7, 2025

Gyre Therapeutics, Inc. (GYRE) Q3 Earnings Surpass Estimates

Gyre Therapeutics, Inc. (GYRE) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of $0.05 per share. This compares to earnings of $0.02 per share a year ago.

Zacks Investment Research • Nov 7, 2025

New Strong Sell Stocks for Oct. 17th

GYRE, DAR and CRLBF have been added to the Zacks Rank #5 (Strong Sell) List on October 17, 2025.

Zacks Investment Research • Oct 17, 2025

Gyre Therapeutics Announces Completion of Patient Enrollment in Phase 3 Clinical Trial of Pirfenidone Capsules for the Treatment of Pneumoconiosis

SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis.

GlobeNewsWire • Oct 15, 2025

Gyre Therapeutics to Present Results from Positive Phase 3 Clinical Trial Evaluating Hydronidone for the Treatment of Liver Fibrosis in Chronic Hepatitis B at AASLD—The Liver Meeting® 2025

Gyre Therapeutics to Present Results from Positive Phase 3 Clinical Trial Evaluating Hydronidone for the Treatment of Liver Fibrosis in Chronic Hepatitis B

GlobeNewsWire • Oct 14, 2025

Gyre Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference

SAN DIEGO, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that management will present at the H.C.

GlobeNewsWire • Sep 5, 2025

Gyre Therapeutics Gains Attention As Under-The-Radar Liver Fibrosis Drug Maker

The global biopharmaceutical landscape is rapidly evolving, driven by innovations targeting complex diseases like organ fibrosis and liver conditions. As companies push the boundaries of medical science, new therapies are emerging that promise to transform patient care and redefine market leadership in these critical areas.

Benzinga • Aug 26, 2025

Gyre Therapeutics Announces the Appointment of Dan Weng, M.D., to Board of Directors

SAN DIEGO, Aug. 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced the appointment of Dan Weng, M.D., to its Board of Directors (the “Board”) effective August 18, 2025.

GlobeNewsWire • Aug 22, 2025

Gyre Therapeutics Reports Second Quarter 2025 and Year-to-Date Financial Results and Provides Business and Leadership Update

Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role Revenue of $26.8 million and $48.8 million for the three and six months ended June 30, 2025, respectively GAAP basic EPS: $0.00 and $0.04 for the three and six months ended June 30, 2025, respectively Pivotal Phase 3 trial of Hydronidone (F351) in CHB-associated liver fibrosis demonstrated statistically significant fibrosis regression after 52 weeks of treatment; Phase 2 trial in the United States evaluating Hydronidone for the treatment of MASH-associated liver fibrosis expected to initiate in 2H 2025, pending regulatory approval Successfully launched Etorel (nintedanib ethanesulfonate soft capsules) in the PRC for the treatment of SSc-ILD and PF-ILD Announced NMPA approval for clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications with Phase 2/3 trial anticipated in 2H 2025 First volunteer dosed in Phase 1 clinical trial of F230 for treatment of PAH SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the second quarter ended June 30, 2025 and provided a business and leadership update. Dr. Han Ying has stepped down as Chief Executive Officer and will transition into the role of Senior Vice President, Science and will oversee research and discovery activities to support Gyre's fibrosis focused pipeline.

GlobeNewsWire • Aug 11, 2025

Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension in China

SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (“ETA”) receptor antagonist, for the treatment of pulmonary arterial hypertension (“PAH”). This milestone marks Gyre's entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options.

GlobeNewsWire • Jun 10, 2025