Gyre Therapeutics, Inc. (GYRE)

NCM – Цена в реальном времени. Валюта: USD

7.30

+0.21 (2.96%)

При закрытии: May 12, 2026, 4:00 PM EDT

7.70

+0.40 (5.48%)

После закрытия: May 12, 2026, 7:56 PM EDT

12.05.2026

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd.

07.05.2026

Gyre Therapeutics, Inc. (GYRE) Reports Q1 Loss, Lags Revenue Estimates

Gyre Therapeutics, Inc. (GYRE) came out with a quarterly loss of $0.05 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to break-even earnings per share a year ago.

07.05.2026

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China's CDE in March 2026 Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers First patient enrolled in Phase 2/3 trial evaluating ETUARY ™ for radiation-induced lung injury, including immune-related pneumonitis SAN DIEGO, May 07, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (Nasdaq: GYRE), an innovative, commercial stage biopharmaceutical company with operations in the United States and China, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “Building on our successful pre-NDA meeting with China's CDE at the beginning of the year, we are particularly encouraged by the NMPA's priority review designation for F351, reinforcing both the strength of our clinical data and the significant unmet need in liver fibrosis,” said Ying Luo, Chief Executive Officer of Gyre Therapeutics.

04.05.2026

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Post-closing combined company has revenue-producing commercial asset and a robust pipeline of products and product candidates to address multiple therapeutic areas with a focus on fibrosis and inflammatory diseases. China innovation engine provides cost-efficient vehicle for discovery and early-stage development of targeted protein degraders and degrader-antibody conjugates.

17.03.2026

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process.

12.03.2026

Gyre Therapeutics, Inc. (GYRE) Q4 Earnings Miss Estimates

Gyre Therapeutics, Inc. (GYRE) came out with quarterly earnings of $0.04 per share, missing the Zacks Consensus Estimate of $0.08 per share. This compares to earnings of $0.01 per share a year ago.

12.03.2026

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range Full year 2026 revenue guidance of $100.5 to $111.0 million Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026 Alignment with China's Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026 Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients across 18 sites) Hydronidone U.S. Investigational New Drug (IND) application for MASH-associated liver fibrosis anticipated in 2026 SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update. “2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China's CDE,” said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics.

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12.05.2026

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

07.05.2026

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

04.05.2026

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

17.03.2026

Gyre Therapeutics, Inc. (GYRE)

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Gyre Therapeutics, Inc. (GYRE)

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Reports Q1 Loss, Lags Revenue Estimates

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Q4 Earnings Miss Estimates

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

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No Data

Пресс-релизы

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Reports Q1 Loss, Lags Revenue Estimates

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Q4 Earnings Miss Estimates

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Видео

No Data

Пресс-релизы

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

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Gyre Therapeutics, Inc. (GYRE)

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Gyre Therapeutics, Inc. (GYRE)

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Reports Q1 Loss, Lags Revenue Estimates

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Q4 Earnings Miss Estimates

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

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No Data

Пресс-релизы

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Reports Q1 Loss, Lags Revenue Estimates

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (GYRE) Q4 Earnings Miss Estimates

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Видео

No Data

Пресс-релизы

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment