GYRE - Earnings announcements

Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China's CDE in March 2026 Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers First patient enrolled in Phase 2/3 trial evaluating ETUARY™ for radiation-induced lung injury, including immune-related pneumonitis SAN DIEGO, May 07, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (NASDAQ:GYRE), an innovative, commercial stage biopharmaceutical company with

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

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

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

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

Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025 On track to initiate U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025 Commercial launch of avatrombopag maleate tablets expected by the first half of 2025 Commercial launch of nintedanib expected in 2025 Cash and cash equivalents totaled $15.9 million as of September 30, 2024 SAN DIEGO, Nov. 13, 2024 (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 f

Received NMPA approval of avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia, expanding rare disease product lines Received IND approval from NMPA to evaluate F230 for the treatment of pulmonary arterial hypertension U.S. IND submission for F351 in MASH-associated liver fibrosis expected in late 2024 and data readout from Phase 3 trial in CHB-associated liver fibrosis in the PRC expected by early 2025 Cash and cash equivalents totaled $16.1 million as of June 30, 2024 SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs f

Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC remains on track with data anticipated by early 2025 U.S. IND submission to evaluate F351 for the treatment of NASH-associated liver fibrosis expected in late 2024; Phase 2a trial expected to initiate in 2025 Acquired the rights to complementary assets relating to nintedanib through Gyre Pharmaceuticals to improve competitiveness in the PRC Cash and cash equivalents totaled $29.8 million as of March 31, 2024 SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic thera

Data readout from Phase 3 clinical trial in the People's Republic of China ("PRC") evaluating F351 for the treatment of CHB-associated liver fibrosis expected by early 2025 U.S. Phase 2a clinical trial evaluating F351 for the treatment of NASH-associated liver fibrosis planned for 2025 Appointed Dr. Han Ying as Chief Executive Officer Acquired indirect controlling interest in Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd) as part of business combination agreement with GNI Cash and cash equivalents totaled $33.5 million as of December 31, 2023 SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. ("Gyre") (NASDAQ:GYRE), a cli