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 headquartered in San Diego, CA. The company is at the forefront of developing and commercializing innovative therapeutics aimed at addressing serious medical conditions, particularly those with unmet treatment needs. Gyre's primary focus is on the development of Hydronidone (F351), an investigational drug designed for the treatment of Metabolic Dysfunction Associated Steatohepatitis (MASH)-associated liver fibrosis, a condition previously known as Nonalcoholic Steatohepatitis (NASH) in the United States. Hydronidone is currently being evaluated under an active Investigational New Drug (IND) application and is showing promise in preclinical studies.
Gyre's scientific approach leverages protease-based therapeutic candidates, with a mission to provide new and better treatment options for patients with chronic liver diseases. Recent preclinical results have highlighted Hydronidone’s potential to ameliorate liver fibrosis by inhibiting the activation of hepatic stellate cells (HSCs) through Smad7-mediated degradation of TGFβ, a key mediator in liver fibrogenesis. The clinical program for Hydronidone in the United States is set to begin in 2024.
In addition to its operations in the U.S., Gyre is advancing a diverse pipeline of therapeutic candidates in China, through its controlling interest in Beijing Continent Pharmaceuticals Ltd., Co. This portfolio includes drugs like pirfenidone, F573, F528, and F230, targeting various chronic diseases. Of note, F230, a selective endothelin receptor antagonist, recently received IND approval from China’s National Medical Products Administration (NMPA) for the treatment of pulmonary arterial hypertension (PAH).
Gyre's commitment to innovation is further exemplified by its recent inclusion in the small-cap Russell 2000® and all-cap Russell 3000® Indexes, which underscores the company's growth and visibility in the market. This milestone reflects Gyre's strategic direction and the potential long-term value it aims to deliver to its stockholders.
For more detailed information and updates, visit Gyre's official website at www.gyretx.com.
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.
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.
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