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 San Diego-based biopharmaceutical company focused on fibrosis-first therapies, with its lead candidate Hydronidone targeting liver fibrosis and a commercial and development platform in the People’s Republic of China through Gyre Pharmaceuticals. The GYRE news feed highlights how the company advances anti-fibrotic drugs across liver and lung indications and how these efforts translate into clinical, regulatory and commercial milestones.
Investors following GYRE news can see updates on Hydronidone’s regulatory pathway in China, including its Breakthrough Therapy Designation, pivotal Phase 3 results in chronic hepatitis B-associated liver fibrosis and alignment with China’s Center for Drug Evaluation on a conditional approval NDA and priority review eligibility. News coverage also includes Gyre’s plans for U.S. development of Hydronidone in MASH-associated liver fibrosis, such as IND-related activities, planned Phase 2 trial design and supporting studies like hepatic impairment assessments.
Company announcements also report on the performance and expansion of Gyre’s commercial portfolio in the PRC, including ETUARY (pirfenidone capsules) for idiopathic pulmonary fibrosis, Etorel (nintedanib ethanesulfonate soft capsules) for systemic sclerosis-associated and progressive fibrosing interstitial lung disease, and Contiva (avatrombopag maleate tablets) for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura. Additional news items cover pipeline progress for pirfenidone in pneumoconiosis and oncology-related pulmonary complications, F573 for acute/acute-on-chronic liver failure, F528 for COPD and F230 for pulmonary arterial hypertension.
On this page, readers can review press releases on quarterly and year-to-date financial results, public offerings of common stock, leadership and board changes, scientific conference presentations and major clinical trial milestones. Tracking GYRE news helps contextualize the company’s fibrosis-focused strategy, its China-based commercial engine and its U.S. development plans for Hydronidone.
Gyre Therapeutics (Nasdaq: GYRE) has announced the completion of its pivotal Phase 3 trial evaluating F351 (hydronidone) for Chronic Hepatitis B (CHB)-associated liver fibrosis in China. The last patient has finished the 52-week study, with topline data expected in Q1 2025. The trial, involving 248 patients across 39 clinical research hospitals, aims to assess the efficacy of F351 in reducing liver fibrosis.
Key points:
- Randomized, double-blind, placebo-controlled multicenter study
- Primary endpoint: decrease in liver fibrosis by at least one stage after 52 weeks
- F351 designated as a 'Breakthrough Therapy' by China's NMPA in 2021
- Gyre plans to initiate a Phase 2 trial for F351 in MASH-associated fibrosis in the US in 2025
Gyre Therapeutics (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company, has announced its participation in the 8th Annual H.C. Wainwright MASH Investor Conference. The company, which focuses on developing treatments for various chronic organ diseases, will be represented by CEO Han Ying, PhD, who will present a company overview on Monday, October 7, 2024, at 2:30 PM ET (11:30 AM PT).
Investors and interested parties can access the live webcast of the presentation through the Events and Presentations page on Gyre's website. For those unable to attend the live session, a replay of the webcast will be made available following the event.
Gyre Therapeutics (Nasdaq: GYRE), a commercial-stage biotech company focusing on chronic organ diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. CEO Han Ying, PhD, will present a company overview on September 10, 2024, at 8:30 AM ET.
The presentation will be available via live webcast on Gyre's website Events and Presentations page. For those unable to attend the live session, a replay will be accessible afterward. This event provides an opportunity for investors to gain insights into Gyre's operations, clinical development programs, and future prospects in the biotechnology sector.
Gyre Therapeutics (Nasdaq: GYRE) reported Q2 2024 financial results and provided a business update. Key highlights:
- Received NMPA approval for avatrombopag maleate tablets to treat CLD-associated thrombocytopenia
- Gained NMPA IND approval for F230 in pulmonary arterial hypertension
- U.S. IND submission for F351 in MASH-associated liver fibrosis expected late 2024
- Phase 3 trial data for F351 in CHB-associated liver fibrosis expected early 2025
- Q2 2024 revenues: $25.2 million, down from $29.3 million in Q2 2023
- Q2 2024 net income: $4.5 million, up from $3.8 million in Q2 2023
- Cash and equivalents: $16.1 million as of June 30, 2024
The company expects its cash resources to fund operations for at least 12 months.
Gyre Therapeutics (Nasdaq: GYRE), a commercial-stage biotech company, has announced its participation in the upcoming Sidoti August Virtual Investor Conference. Han Ying, PhD, the company's CEO, will present a company overview on Thursday, August 15, 2024, at 10:45 a.m. ET (7:45 a.m. PT).
Gyre Therapeutics is known for its self-sustainable approach and focuses on developing treatments for various chronic organ diseases. Interested parties can register in advance for the presentation webcast. For those unable to attend live, a replay will be available on the Events and Presentations page of Gyre's website following the session.
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.