Gyre Therapeutics

GYRE

Market cap $844M

Acquisition will create a U.S.- and China-based fully integrated biopharmaceutical company with revenue-producing commercial assets and a robust pipeline of degraders, targeting inflammatory diseases and cancers. Access to degrader-antibody conjugates (DACs) platform technology for future discovery engine.

Gyre Pharmaceuticals completed a Pre-NDA meeting with China's CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review eligibility, subject to formal approval. Gyre Pharmaceuticals plans to submit an NDA in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China.

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.

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.

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

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.

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

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.

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.

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.