
Monday, August 10, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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The Cullgen Acquisition Highlights 2Q26. Gyre reported a 2Q26 loss of $14.3 million, or $(0.12) per share. Revenues of $29.1 million compared with $22.5 million in 1Q26, consistent with our estimates. We have expected a transition year between Etuary market maturity and the expected hydronidone launch, supplemented by the Cullgen acquisition. Revenue guidance for FY2026 was reiterated at $100.5 to $111.0 million. Cash and equivalents on June 30, 2026 were $103.2 million.
Hydronidone NDA Accepted For Review. In May 2026, the New Drug Application (NDA) for hydronidone (previously F351) was accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This followed the Priority Review status granted by the NMPA in March.
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