GYRE

Newtown Square, Pennsylvania--(Newsfile Corp. - May 27, 2026) - Kaskela Law LLC is investigating Gyre Therapeutics, Inc. (NASDAQ: GYRE) ("Gyre") on behalf of the company's long-term shareholders. The investigation seeks to determine whether Gyre and/or the company's officers and directors violated the securities laws or breached their fiduciary duties in connection with recent corporate actions.

GYRE, FSUN and AKZOY have been added to the Zacks Rank #5 (Strong Sell) List on May 27, 2026.

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.

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.

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.