Gyre Therapeutics

NMPA Approves Gyre Therapeutics' Clinical Trial for Pirfenidone in Oncology-Related Lung Complications

2 months ago

• China's NMPA has approved Gyre Therapeutics' clinical trial application to evaluate pirfenidone for treating radiation-induced lung injury and immune-related pneumonitis in cancer patients. • The adaptive Phase 2/3 trial represents a significant expansion of pirfenidone beyond its established use in idiopathic pulmonary fibrosis into oncology supportive care. • Currently, no targeted therapies exist for lung injuries caused by radiation or immunotherapy, with 5-25% of radiation therapy patients and 13-19% of immunotherapy patients experiencing pulmonary complications.

Mineralys Therapeutics Secures $175 Million in Public Offering to Advance Aldosterone Inhibitor for Cardiorenal Diseases

2 months ago

• Mineralys Therapeutics has priced its public offering at $13.50 per share, raising approximately $175 million to fund the clinical development of lorundrostat, its aldosterone synthase inhibitor. • The biopharmaceutical company is targeting multiple conditions driven by dysregulated aldosterone, including hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA). • The offering, expected to close around March 13, 2025, includes an option for underwriters to purchase an additional 1.94 million shares within 30 days.

Gyre Therapeutics Anticipates Key Data Readouts and Product Launches in 2025

5 months ago

• Gyre Therapeutics expects topline results from its Phase 3 trial of F351 for Chronic Hepatitis B-associated liver fibrosis in China during Q1 2025. • The company plans to initiate a Phase 2 trial of F351 in MASH-associated liver fibrosis in the U.S. in 2025, contingent on positive Phase 3 results. • Gyre is also preparing to launch Avatrombopag maleate tablets for thrombocytopenia and Nintedanib for idiopathic pulmonary fibrosis in China in 2025.

Gyre Therapeutics Anticipates Key Data and Product Launches in 2025

6 months ago

• Gyre Therapeutics reported Q3 2024 revenues of $25.5 million, a decrease from $32.0 million in Q3 2023, alongside a net income of $2.9 million. • The company completed its Phase 3 trial for F351 in CHB-associated liver fibrosis, with topline data expected in the first quarter of 2025. • Commercial launches of avatrombopag and nintedanib in China are planned for 2025, expanding Gyre's product offerings. • A U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis is slated to begin in 2025, pending Phase 3 results.

Gyre Therapeutics Announces Positive Phase 3 Trial Completion and Upcoming Commercial Launches

6 months ago

• Gyre Therapeutics completed its pivotal Phase 3 trial of F351 for chronic hepatitis B-associated liver fibrosis in China, with topline data expected in Q1 2025. • The company anticipates launching avatrombopag maleate tablets for chronic liver disease-associated thrombocytopenia in China in the first half of 2025. • Gyre plans to commercialize nintedanib for idiopathic pulmonary fibrosis in China in 2025, expanding its presence in the pulmonary fibrosis market. • A Phase 2 clinical trial of F351 in MASH-associated liver fibrosis in the U.S. is on track to begin in 2025, pending Phase 3 results.

Gyre Therapeutics' F351 Completes Phase 3 Trial for CHB-Associated Liver Fibrosis

7 months ago

• Gyre Therapeutics has completed its pivotal Phase 3 trial of F351 (hydronidone) for chronic hepatitis B (CHB)-associated liver fibrosis in China. • The randomized, double-blind, placebo-controlled trial enrolled 248 patients receiving F351 or placebo with entecavir antiviral therapy. • Topline data from the 52-week study, which aims to reduce liver fibrosis, is expected in the first quarter of 2025. • Gyre plans to initiate a Phase 2 trial in the U.S. for F351 in Metabolic Dysfunction-Associated Steatohepatitis (MASH)-associated fibrosis in 2025.

Catalyst Biosciences Announces Positive Factor IX Clinical Data

8 years ago

Catalyst Biosciences, Inc. has announced positive clinical data from the first Cohort of its ongoing Phase 1/2 proof-of-concept clinical trial for CB 2679d, a next-generation coagulation Factor IX variant, in individuals with severe hemophilia B. The data shows CB 2679d is approximately 22 times more potent than current hemophilia B therapy, with a longer circulation time in the body.