Friday, May 08, 2026
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.
Cullgen Acquisition Has Been Completed. Gyre Therapeutics reported a 1Q26 loss of $9.9 million or $(0.11) per share, consistent with our expectations for a transition year between maturing products and the introduction of Hydronidone. Importantly, the company completed the acquisition of Cullgen, a private company with protein targeting and degradation technologies. This acquisition expands the company’s technology and pipeline beyond fibrosis. Cash and equivalents on March 31, 2026, was $79.2 million.
The Hydronidone NDA Has Been Submitted. Gyre completed the NDA submission for Hydronidone, its pirfenidone derivative, for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis. In March, Hydronidone was awarded Priority Review by the Center for Drug Evaluation (CDE, a division of China’s National Medical Products Administration or NMPA). This was in recognition of its efficacy and potential impact on patient outcomes. The NDA is currently under review for completeness, with acceptance of the filing expected in 2Q26.
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