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GYRE THERAPEUTICS, INC. (GYRE)

(10% Negative) GYRE THERAPEUTICS, INC. (GYRE) Announces Delay in operations Trials for chronic hepatitis B (CHB)-induced liver fibrosis Due to Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review

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  • News bot May 12, 2026, 9:03 p.m.

    📋 GYRE THERAPEUTICS, INC. (GYRE) - Clinical Trial Update

    Filing Date: 2026-05-12

    Accepted: 2026-05-12 17:03:02

    Event Type: Clinical Trial Update

    Event Details:

    GYRE THERAPEUTICS, INC. (GYRE) Announces Clinical Trial Update GYRE THERAPEUTICS, INC. (GYRE) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: operations, product
    • Diseases/Conditions: chronic hepatitis B (CHB)-induced liver fibrosis, our F351 program
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Patient Enrollment, Regulatory Process, Regulatory Timeline
    • Collaboration: New Drug Application
      • anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the risk that the combined company may not be able to successfully integrate the businesses and realize the expected benefits of the acquisition in a timely manner or at all; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025
      • targeting the TGF-β1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC) and MASH-associated liver fibrosis initially in the United States. In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: GYRE THERAPEUTICS, INC.
    • Ticker Symbol: GYRE

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