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 (GYRE) has received NMPA approval in China for a clinical trial evaluating pirfenidone capsules in treating oncology-related pulmonary complications. The study will focus on radiation-induced lung injury (RILI) and checkpoint inhibitor pneumonitis (CIP).
The company plans to conduct an adaptive Phase 2/3 trial to assess pirfenidone's effectiveness beyond its current use in idiopathic pulmonary fibrosis. This expansion targets significant unmet needs, as 5-25% of radiation therapy patients experience lung damage, while 13-19% of patients on immune checkpoint inhibitors develop CIP, accounting for 35% of immune-related adverse event deaths.
The trial is scheduled to begin in the second half of 2025 at leading academic and oncology centers across China. This initiative aims to provide an alternative to corticosteroids, the current standard treatment which has significant long-term side effects.
Gyre Therapeutics (GYRE) has published the protocol for its Phase 3 trial of hydronidone (F351) in the Journal of Clinical and Translational Hepatology. The trial evaluates the treatment of liver fibrosis in patients with chronic hepatitis B (CHB).
The randomized, double-blind, placebo-controlled multicenter study has completed enrollment of 248 patients across 44 clinical research hospitals in China. Patients were divided equally between F351 and placebo groups, with both receiving entecavir antiviral basic therapy for CHB. The primary endpoint measures the decrease in liver fibrosis by at least one stage after 52 weeks using the Ishak Scoring System.
The drug received 'Breakthrough Therapy' designation from China's NMPA in 2021. Topline results are expected in Q2 2025.
Gyre Therapeutics (NASDAQ: GYRE) reported its Q4 and full year 2024 financial results, highlighting key developments in both commercial and clinical portfolios. The company generated $105.8 million in revenue for 2024, down from $113.5 million in 2023, primarily due to decreased ETUARY sales.
Key highlights include:
- Pivotal Phase 3 trial data in CHB-associated liver fibrosis expected in Q2 2025
- Planned commercial launch of nintedanib for IPF and avatrombopag for CLD-associated thrombocytopenia in 2025
- Full year 2025 revenue guidance of $118-128 million, projecting 11.3-20.8% growth
- Cash position of $51.2 million as of December 31, 2024
For Q4 2024, the company reported net income of $0.6 million, compared to a $101.0 million loss in Q4 2023. Full-year 2024 net income was $17.9 million, versus an $85.5 million loss in 2023.
Gyre Therapeutics (NASDAQ: GYRE) announced significant changes to its Board of Directors. Ping Zhang has been appointed as the lead independent director and will serve on the Nominating and Corporate Governance Committee. Zhang, currently Managing Partner at String Capital Management, brings extensive financial experience from roles at AEON Life Insurance, Japan Asia Investment, AEA Investors, and Mitsubishi UFJ Securities.
Concurrent with Zhang's appointment, Ying Luo, Ph.D. has stepped down as Chairman and Board member of both Gyre and Gyre Pharmaceuticals to focus on responsibilities at GNI Group Songjiang Ma has been appointed as the new Chairman of Gyre Pharmaceuticals, the company's majority-owned subsidiary in China.
Gyre Therapeutics (NASDAQ: GYRE) reported Q3 2024 financial results with revenues of $25.5 million, down from $32.0 million in Q3 2023. The company completed its pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis, with data expected in Q1 2025. Key developments include planned commercial launches of avatrombopag and nintedanib in 2025, and preparations for a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis. The company reported Q3 net income of $2.9 million, down from $7.5 million in Q3 2023, with cash and equivalents of $15.9 million as of September 30, 2024.
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.
