Welcome to our dedicated page for Gyre Therapeutics news (Ticker: GYRE), a resource for investors and traders seeking the latest updates and insights on Gyre Therapeutics stock.
Gyre Therapeutics Inc (Nasdaq: GYRE) is a clinical-stage biopharmaceutical company advancing novel therapies for fibrotic diseases, with its lead candidate Hydronidone targeting MASH-associated liver fibrosis. This page provides centralized access to official announcements, research milestones, and regulatory developments essential for monitoring the company's progress.
Investors and researchers will find timely updates on clinical trial data, partnership agreements, and pipeline expansions across Gyre's U.S. and China operations. Our curated collection includes press releases detailing mechanistic studies, financial reports, and strategic initiatives shaping the company's anti-fibrotic research programs.
Key content categories cover phase trial results, regulatory submissions, intellectual property developments, and management commentary on therapeutic innovations. All materials are sourced directly from company filings and verified industry channels to ensure accuracy.
Bookmark this page for streamlined tracking of Gyre's scientific advancements and business decisions impacting the treatment landscape for chronic organ diseases. Check regularly for objective updates on developments in liver fibrosis research and related therapeutic areas.
Gyre Therapeutics (Nasdaq: GYRE) has announced the appointment of David M. Epstein, Ph.D., to its Board of Directors, effective August 6, 2024. Dr. Epstein will serve on the Audit Committee and Compensation Committee of the Board. With extensive global experience in biotech companies across the U.S. and Asia, Dr. Epstein is expected to contribute significantly to Gyre's advancement of its clinical and pre-clinical assets.
Dr. Epstein is currently the co-founder, director, President, and CEO of PairX Bio Pte. , a Singapore-based biotech company developing next-generation cancer-selective biologics. His impressive career includes co-founding Black Diamond Therapeutics (Nasdaq: BDTX) and serving as Chief Scientific Officer at OSI Pharmaceuticals. He also played a key role in developing Izervay™, an anti-C5 aptamer for treating age-related macular degeneration, which was recently acquired by Astellas Pharma Inc. for $5.9 billion.
Gyre Therapeutics (Nasdaq: GYRE) announced the approval of its avatrombopag maleate tablets by China's National Medical Products Administration (NMPA) for treating thrombocytopenia (TP) associated with chronic liver disease (CLD). This approval marks a significant milestone for Gyre as it expands its rare disease product line. TP, a common and potentially severe complication in CLD patients, poses life-threatening risks, especially during diagnostic procedures or therapy. The approval allows Gyre to launch avatrombopag in China, providing a new treatment option for these patients. The drug, an oral thrombopoietin receptor agonist, was initially approved by the FDA in May 2018.
Gyre Therapeutics (Nasdaq: GYRE) announced the publication of a study on hydronidone (F351) in the Journal of Gastroenterology and Hepatology. The in vivo and in vitro studies show that hydronidone induces apoptosis in activated hepatic stellate cells (aHSCs) via endoplasmic reticulum stress-associated mitochondrial apoptotic pathway, suggesting its potential to treat liver fibrosis. Preclinical findings indicate hydronidone attenuates liver fibrosis by inhibiting aHSCs. Currently, Gyre is evaluating hydronidone in a Phase 3 trial for Chronic Hepatitis B-associated liver fibrosis, with results expected by early 2025, and plans to start a Phase 2a trial for NASH-associated liver fibrosis afterward.
Gyre Therapeutics (Nasdaq: GYRE), a biotech firm specializing in anti-fibrotic treatments, has received approval from China's NMPA for its Investigational New Drug (IND) application for F230. This drug, a selective endothelin receptor antagonist, is aimed at treating pulmonary arterial hypertension (PAH), a severe and progressive disorder with no current cure. Licensed from Eisai through GNI Group, F230 showed promising preclinical results, significantly reducing pulmonary arterial pressure and other related metrics. Gyre aims to improve patient outcomes and is also exploring additional indications for F230.
Gyre Therapeutics (Nasdaq: GYRE), a clinical-stage biotechnology company developing anti-fibrotic treatments, announced its expected addition to the Russell 2000® and Russell 3000® indexes after the 2024 Russell Indexes annual reconstitution. This inclusion will take effect after U.S. market close on June 28, 2024. The Russell Indexes reconstitution captures the 4,000 largest U.S. stocks, ranking them by market capitalization. CEO Han Ying, Ph.D., highlighted that this milestone will boost Gyre's visibility as it advances its F351 program in both the PRC and the U.S., aiming to create long-term value for stockholders. Approximately $12.1 trillion in assets are benchmarked against the Russell U.S. Indexes.
Gyre Therapeutics reported first-quarter 2024 financial results, with $29.8 million in cash and cash equivalents as of March 31, 2024. The company's Phase 3 clinical trial of F351 for CHB-associated liver fibrosis in the PRC is on track, with data expected by early 2025. Gyre plans to initiate a Phase 2a trial for NASH-associated liver fibrosis in the U.S. in 2025. Additionally, Gyre acquired rights to assets related to nintedanib through Gyre Pharmaceuticals to enhance competitiveness. The company's ETUARY sales reached $26.9 million in Q1 2024, showing growth from the same period in 2023. Financially, Gyre had revenues of $27.2 million for the quarter ended March 31, 2024, with net income of $9.9 million and net income attributable to common stockholders of $7.5 million. Gyre also reported adjusted net income to provide additional insights for investors.
