Tuesday, March 11, 2025
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
We Are Initiating Coverage Of Gyre Therapeutics With An Outperform Rating. Gyre Therapeutics is a pharmaceutical company developing drugs for inflammatory diseases that lead to fibrosis. It currently markets Etuary (pirfenidone) in China for idiopathic pulmonary fibrosis. The lead drug in the pipeline is Hydronidone, a new molecule derived from pirfenidone, that is in a Phase 3 clinical trial in China. The data announcement is expected to report Phase 3 clinical trial results in March 2025.
Hydronidone Was Developed To Improve Efficacy and Side Effects. Hydronidone is a structural analogue of pirfenidone that was developed to improve efficacy with a more tolerable side effect profile. It is in Phase 3 trial in China for fibrosis of the liver after hepatitis B (HBV) infections. Hydronidone targets steps in the Transforming Growth Factor (TGF)-ß1 pathway as well as the downstream genes and liver cells it activates to produce fibrotic tissue. Data from the Phase 3 in China will be used to design a Phase 2a trial in the US, expected to begin in late FY2025.
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