GYRE

8-K/A - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

PRE 14A - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (NASDAQ:GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on Januar

10-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range Full year 2026 revenue guidance of $100.5 to $111.0 million Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026 Alignment with China's Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026 Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial(272 patients acros

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

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. Strengthened leadership team designed to support future global growth.Transaction is anticipated to close early in the second quarter of 2026. An updated corporate presentation has been posted to the Gyre and Cullgen websites. SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or the Company) (NASDAQ:GYRE), an innovative, commercial-stage biopharmaceutical compan

4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

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. SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or the Company) (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 majority-owned subsidiary in

10-Q - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

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.Operating income increased 64% to $6.9 million, as operating expenses gr

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. A total of 272 patients have been enrolled in this multicenter, randomized, double-blind, placebo-controlled trial being conducted at 18 clinical research centers across China. The trial is desig

SAN DIEGO, Oct. 14, 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 it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting® 2025 is being held November 7-10, 2

Jefferies initiated coverage of Gyre Therapeutics with a rating of Buy and set a new price target of $16.00

8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)

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. Wainwright 27th Annual Global Investment Conference on Wednesday, September 10, 2025 at 12:30 p.m. ET. To register in advance for the presentation webcast, sign up here. The live webcast of the presentation will be also available on the Events and Presentations page of Gyre's website. A webcast replay will also be accessible following the live session. About Gyre Therapeutics Gyre Therapeut

4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

3 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)

H.C. Wainwright initiated coverage of Gyre Therapeutics with a rating of Buy and set a new price target of $18.00