Gyre Therapeutics Inc Stock Price, News & Analysis

Gyre Therapeutics (Nasdaq: GYRE) reported Q3 2025 results and a business update on Nov 7, 2025. Q3 revenue was $30.6M (+20% YoY) and GAAP net income was $5.9M. Nine-month revenue totaled $79.4M and cash and deposits were $80.3M as of Sept 30, 2025 (up 57% YTD). The company revised full-year 2025 revenue guidance to $115–118M (down from $118–128M) citing delayed Etorel rollout and government procurement uncertainty. Commercial sales in Q3 included ETUARY $27.7M, Etorel $1.5M, and Contiva $1.2M. Pipeline: Hydronidone NDA interactions in China progressing with Priority Review discussions; U.S. IND timing moved to 2026. Pirfenidone Phase 3 pneumoconiosis enrollment completed (272 patients).

Gyre Therapeutics (NASDAQ: GYRE) announced completion of patient enrollment in its 52-week Phase 3 trial of Pirfenidone capsules for pneumoconiosis on Oct 15, 2025. The randomized, double-blind, placebo-controlled study enrolled 272 patients across 18 centers in China to evaluate 52 weeks of treatment for progressive pulmonary fibrosis caused by mineral dust exposure. The company noted a significant unmet medical need: no approved therapies in China specifically target fibrotic mechanisms in pneumoconiosis, which affects >450,000 surviving patients in China. The trial completion of enrollment is a key operational milestone ahead of safety and efficacy readouts.

Gyre Therapeutics (Nasdaq: GYRE) will present results from a positive Phase 3 trial of Hydronidone for treatment of liver fibrosis in chronic hepatitis B at AASLD The Liver Meeting® 2025.

The abstract was selected as a Poster of Distinction. Presentation details: Phase 3 Trial of Hydronidone for Liver Fibrosis in Chronic Hepatitis B, presenting author Prof. Lungen Lu, M.D., Session: Hepatitis B ("1187-1367"), Date: Friday, November 7, 2025, Time: 8:00 a.m.–5:00 p.m. ET, Publication Number: 1121. The meeting runs November 7–10, 2025 in Washington D.C.

Gyre Therapeutics (Nasdaq: GYRE), a commercial-stage biopharmaceutical company focused on fibrosis-first therapies, will participate in the H.C. Wainwright 27th Annual Global Investment Conference. The company's management will deliver their presentation on September 10, 2025, at 12:30 p.m. ET.

Investors can register in advance for the presentation webcast, which will be available on Gyre's website Events and Presentations page. A replay will be accessible after the live session.

Gyre Therapeutics (NASDAQ: GYRE), a commercial-stage biopharmaceutical company focused on fibrosis-first therapies, has appointed Dr. Dan Weng to its Board of Directors effective August 18, 2025.

Dr. Weng brings nearly 40 years of experience in managing global clinical trials and currently serves as President and CEO of Medelis, Inc. His extensive background includes executive positions at major CROs and research roles at prestigious institutions including Harvard Medical School and Massachusetts General Hospital.

The appointment comes at a strategic time as Gyre aims to expand its commercial reach and advance its multi-national pipeline. Dr. Weng's expertise in regulatory affairs and clinical trial management is expected to support the company's growth initiatives.

Gyre Therapeutics (NASDAQ:GYRE) reported Q2 2025 financial results with revenue of $26.8 million and net income of $1.6 million. The company announced a leadership change as Ping Zhang, Executive Chairman, was appointed interim CEO while Dr. Han Ying transitions to SVP of Science.

Key highlights include positive Phase 3 results for Hydronidone in CHB-associated liver fibrosis, successful launch of Etorel for SSc-ILD and PF-ILD treatments, and NMPA approval for pirfenidone clinical trials. The company reaffirmed its full-year 2025 revenue guidance of $118-128 million.

Financial position remains strong with $75.9 million in total cash and investments, bolstered by a $23 million public offering completed in May 2025.

Gyre Therapeutics (NASDAQ: GYRE) has initiated dosing in a Phase 1 clinical trial for F230, a novel endothelin A receptor antagonist, targeting pulmonary arterial hypertension (PAH) in China. F230, licensed from Eisai Co. through GNI Group Ltd., is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure. The Phase 1 trial will assess safety, tolerability, and pharmacokinetics in healthy volunteers. This expansion aligns with Gyre's fibrosis-first strategy and targets China's PAH market, valued at $370 million in 2023 with projected growth to $480 million by 2031. The company is also advancing Hydronidone (F351), which succeeded in a Phase 3 trial for CHB-fibrosis, with an NDA submission planned for Q3 2025 in China and preparations for a Phase 2 MASH fibrosis trial in the US.

Gyre Therapeutics (NASDAQ: GYRE) has successfully closed its public offering of 2,555,555 shares of common stock at $9.00 per share, including the full exercise of underwriters' option for 333,333 additional shares. The offering generated gross proceeds of approximately $23.0 million. Jefferies served as lead book-running manager, with H.C. Wainwright & Co. as co-manager. The proceeds will fund Gyre's Phase 2 clinical trial of F351 for MASH-associated liver fibrosis in the United States, support research and development, manufacturing scale-up, and provide working capital for general corporate purposes. The offering was made pursuant to an effective shelf registration statement filed with the SEC.

Gyre Therapeutics (NASDAQ: GYRE) has announced the pricing of its public offering of 2,222,222 shares of common stock at $9.00 per share, aiming to raise approximately $20.0 million in gross proceeds. The underwriters have a 30-day option to purchase up to an additional 333,333 shares. The offering is expected to close around May 27, 2025.

The biotechnology company plans to use the proceeds to advance its Phase 2 clinical trial of F351 in MASH-associated liver fibrosis in the United States, fund research and development, manufacturing scale-up, and support working capital needs. Jefferies is serving as the lead book-running manager, with H.C. Wainwright & Co. as co-manager for the offering.