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.
- Commercial launch of avatrombopag in March 2025 for thrombocytopenia - Upcoming nintedanib launch in May 2025 for fibrosing interstitial lung disease - NMPA approval for pirfenidone clinical trial in radiation-induced lung injury - Database lock achieved for Phase 3 Hydronidone trial in Chronic Hepatitis B
The company's flagship product ETUARY® (pirfenidone) generated $21.7 million in Q1 sales, maintaining market leadership in IPF treatment despite year-over-year decline. Gyre maintains a strong financial position with $51.3 million in cash and equivalents as of March 31, 2025, which is expected to fund operations for the next 12 months.
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.
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