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. reports commercial-stage biopharmaceutical developments tied to organ fibrosis, inflammatory diseases and cancer-focused pipeline expansion. The company generates revenue through Gyre Pharmaceuticals in China, including ETUARY® (pirfenidone) and other commercial products, while advancing Hydronidone (F351) for chronic hepatitis B-associated liver fibrosis and MASH-associated liver fibrosis.
Recurring updates include quarterly results, revenue guidance, China NMPA and CDE interactions, NDA disclosures for F351, pirfenidone indication-expansion studies in lung fibrosis, and integration of Cullgen’s targeted protein degrader and degrader antibody conjugate candidates after the completed acquisition.
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.
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