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. PAH is recognized in China's National Rare Disease Catalog, underscoring its si

SAN DIEGO, May 29, 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 closed its previously announced underwritten public offering of 2,555,555 shares of its common stock, including the full exercise by the underwriters of their option to purchase an additional 333,333 shares, at a public offering price of $9.00 per share, less the underwriting discount. The gross proceeds of the offering to Gyre, before deducting underwriting discounts and commissions and other offering expenses payable by Gyre,

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced the pricing of its previously announced underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share. In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 333,333 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds of the offering to Gyre, before deducting the underwriting discounts and commissions and other of

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the

Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002).Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events.Breakthrough Therapy Designation granted by China's National Medical Products Administration ("NMPA") in 2021 supports potential first-in-class approval in CHB-associated liver fibrosis ("CHB fibrosis").Gyre intends to seek accelerated approval for Hydronidone in CHB fibrosis, with a New Drug Application ("NDA") submission to the NMPA expected in Q3 2025. U.S. Phase 2 trial in MASH-associated liver fibrosis expected to begin in

Q1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03Completed data collection and achieved database lock for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B ("CHB")-associated liver fibrosis; currently reviewing data and on track to report topline results in Q2 2025Received IND approval from China's National Medical Products Administration ("NMPA") for a new indication of pirfenidone to treat radiation-induced lung injury ("RILI"), with or without immune-related pneumonitis ("CIP"), marking Gyre's first entry into oncology supportive care spaceInitiated commercialization of avatrombopag in China in March 2025, building a strategic presence with liver disease specialistsNin

SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People's Republic of China ("PRC") has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury (RILI), with or without immune-related pneumonitis (CIP). This regulatory milestone marks the expansion of pirfenidone beyond its established role in idiopathic pulmonary fibrosis (

SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial" in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B ("CHB"). The published protocol outlines patient inclusion criteria,

Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025 Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025 Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025 Full year 2025 total revenue guidance of $118 to $128 million SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced financial results for the fourth quarter and full

SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced the appointment of Ping Zhang to its Board of Directors (the "Board") as the lead independent director of the Board and a member of the Nominating and Corporate Governance Committee of the Board. In addition, Ying Luo, Ph.D. resigned as Chairman and a member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre's majority indirectly owned subsidiary in the People's Republic of China ("PRC"), to focus on other responsibilities at GNI Grou

Noble Capital Markets initiated coverage of Gyre Therapeutics with a rating of Outperform

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