Gyre Therapeutics Inc Stock Price, News & Analysis

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.

Gyre Therapeutics (NASDAQ: GYRE) has announced a proposed underwritten public offering of common stock shares. The biotechnology company, focused on organ fibrosis, will grant underwriters a 30-day option to purchase additional shares at the public offering price. The net proceeds will fund multiple initiatives, including: - Advancing Phase 2 clinical trial of F351 for MASH-associated liver fibrosis in the US - Research and development activities - Manufacturing and scale-up operations - Working capital and general corporate purposes Jefferies is serving as the lead book-running manager, with H.C. Wainwright & Co. as co-manager. The offering will be made through a shelf registration statement previously filed with the SEC.

Gyre Therapeutics (NASDAQ: GYRE) announced positive results from its pivotal Phase 3 trial of Hydronidone for treating chronic hepatitis B (CHB)-associated liver fibrosis in China. The trial met its primary endpoint, with 52.85% of Hydronidone-treated patients achieving ≥1-stage fibrosis regression compared to 29.84% for placebo (P=0.0002). The 52-week study involved 248 patients across 39 Chinese hospitals. The drug demonstrated a favorable safety profile with only 4.88% serious adverse events vs. 6.45% for placebo, and no treatment discontinuations. Following these results, Gyre plans to submit a New Drug Application to China's NMPA in Q3 2025. The company also plans to initiate a U.S. Phase 2 trial for MASH-associated liver fibrosis in 2H2025.

Gyre Therapeutics (NASDAQ: GYRE) reported Q1 2025 financial results with net income of $3.7 million and revenue of $22.1 million, down from $27.2 million in Q1 2024. The company reaffirmed its full-year 2025 revenue guidance of $118-$128 million. Key developments include:

- Commercial launch of avatrombopag in March 2025 for thrombocytopenia - Upcoming nintedanib launch in May 2025 for fibrosing interstitial lung disease - NMPA approval for pirfenidone clinical trial in radiation-induced lung injury - Database lock achieved for Phase 3 Hydronidone trial in Chronic Hepatitis B

The company's flagship product ETUARY® (pirfenidone) generated $21.7 million in Q1 sales, maintaining market leadership in IPF treatment despite year-over-year decline. Gyre maintains a strong financial position with $51.3 million in cash and equivalents as of March 31, 2025, which is expected to fund operations for the next 12 months.

Gyre Therapeutics (GYRE) has received NMPA approval in China for a clinical trial evaluating pirfenidone capsules in treating oncology-related pulmonary complications. The study will focus on radiation-induced lung injury (RILI) and checkpoint inhibitor pneumonitis (CIP).

The company plans to conduct an adaptive Phase 2/3 trial to assess pirfenidone's effectiveness beyond its current use in idiopathic pulmonary fibrosis. This expansion targets significant unmet needs, as 5-25% of radiation therapy patients experience lung damage, while 13-19% of patients on immune checkpoint inhibitors develop CIP, accounting for 35% of immune-related adverse event deaths.

The trial is scheduled to begin in the second half of 2025 at leading academic and oncology centers across China. This initiative aims to provide an alternative to corticosteroids, the current standard treatment which has significant long-term side effects.

Gyre Therapeutics (GYRE) has published the protocol for its Phase 3 trial of hydronidone (F351) in the Journal of Clinical and Translational Hepatology. The trial evaluates the treatment of liver fibrosis in patients with chronic hepatitis B (CHB).

The randomized, double-blind, placebo-controlled multicenter study has completed enrollment of 248 patients across 44 clinical research hospitals in China. Patients were divided equally between F351 and placebo groups, with both receiving entecavir antiviral basic therapy for CHB. The primary endpoint measures the decrease in liver fibrosis by at least one stage after 52 weeks using the Ishak Scoring System.

The drug received 'Breakthrough Therapy' designation from China's NMPA in 2021. Topline results are expected in Q2 2025.