SEC Form 10-K filed by Gyre Therapeutics Inc.
$GYRE
Biotechnology: Pharmaceutical Preparations
Health Care
Unavailable
Unavailable
Save time and jump to the most important pieces.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/11/2025 | Outperform | Noble Capital Markets |
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
S-8 - GYRE THERAPEUTICS, INC. (0001124105) (Filer)
10-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)
8-K - GYRE THERAPEUTICS, INC. (0001124105) (Filer)
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
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
SAN DIEGO, Aug. 08, 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 the appointment of David M. Epstein, Ph.D., to Gyre's Board of Directors (the "Board"), effective August 6, 2024. Dr. Epstein will serve as a member of the Audit Committee of the Board and as member of the Compensation Committee of the Board. "We are thrilled to welcome David to the Gyre Board," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. "His extensive global experience in biotech companies across the U.S. and Asia will be
SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), a clinical-stage biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced the appointment of Rodney L. Nussbaum to the Company's Board of Directors and as a member of its Audit Committee. "Rodney has an extensive background in finance, accounting, and financial reporting with nearly four decades of experience working at global auditing and consulting firms," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. "He joins our Board at a pivotal time as we advance our diversified pipeline of anti-fibrotic therapies. We look forwa
4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)
4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)
4 - GYRE THERAPEUTICS, INC. (0001124105) (Issuer)
SC 13D - GYRE THERAPEUTICS, INC. (0001124105) (Subject)
SC 13D - GYRE THERAPEUTICS, INC. (0001124105) (Subject)
Noble Capital Markets initiated coverage of Gyre Therapeutics with a rating of Outperform