Regulatory De-Risking and Priority Review for Hydronidone Underscore Upside in Gyre Therapeutics Shares

H.C. Wainwright analyst Matthew Keller reiterated a Buy rating on Gyre Therapeutics today and set a price target of $18.00.

Matthew Keller has given his Buy rating due to a combination of factors that, in his view, significantly improve the outlook for Gyre Therapeutics. He highlights that Gyre’s subsidiary has reached a clear understanding with China’s Center for Drug Evaluation on the regulatory route for hydronidone in chronic hepatitis B–related liver fibrosis, with existing Phase 3 data considered sufficient to support a conditional approval filing. He also notes that the CDE’s indication that hydronidone qualifies for the Priority Review and Approval Program underscores both the medical need and the perceived innovation of the drug. The expectation of submitting a New Drug Application for conditional approval in the first half of 2026 creates a more defined and visible timeline toward potential commercialization in China.

Keller further views this regulatory update as materially lowering development and approval risk for the program, given the CDE’s alignment with Gyre’s data package and the agreement on conducting an additional confirmatory Phase 3c trial to support eventual full approval. He interprets the strong positive stock reaction relative to the broader biotech index as evidence that the market is beginning to recognize this de-risking and the value of the hydronidone opportunity. In his assessment, the combination of a compelling clinical dataset, a favorable and clarified regulatory path, priority review status, and a near-term NDA catalyst supports continued upside potential for GYRE shares, justifying his Buy recommendation.

According to TipRanks, Keller is an analyst with an average return of -30.3% and a 19.51% success rate. Keller covers the Healthcare sector, focusing on stocks such as Gyre Therapeutics, Galectin Therapeutics, and InflaRx.