Gyre Therapeutics(GYRE.US)

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

H.C. Wainwright analyst Matthew Keller has reiterated a Buy rating on Gyre Therapeutics, setting a price target of $18.00. He cites improved outlook due to regulatory clarity from China's Center for Drug Evaluation regarding hydronidone for chronic hepatitis B-related liver fibrosis. The drug qualifies for Priority Review, indicating medical need and innovation. Keller sees a defined timeline for a New Drug Application in 2026, reducing development risks. He believes the positive stock reaction reflects market recognition of this de-risking and the potential value of hydronidone, supporting his Buy recommendation.

Gyre Therapeutics shares are trading higher after its subsidiary, Gyre Pharmaceuticals, completed a Pre-NDA meeting with China's CDE on its anti-fibrotic therapy Hydronidone. The company plans to submit an NDA in the first half of 2026 and launch a confirmatory clinical trial to support full approval in China.

Altimmune, GH Research, Gyre Therapeutics And Other Big Stocks Moving Higher On Monday

U.S. stocks rose significantly on Monday, with the Dow Jones gaining over 500 points. Notable stock movements included Altimmune Inc, which surged 23.6% after receiving FDA Breakthrough Therapy Designation for Pemvidutide. GH Research PLC gained 33.8% following the lifting of a clinical hold by the FDA. Other significant gainers included Vicor Corp (+20.7%), Critical Metals Corp (+19.6%), and Kosmos Energy Ltd (+19.3%). Rayonier Advanced Materials appointed a new CEO, while Gyre Therapeutics announced alignment with China's CDE for hydronidone approval. Overall, many stocks in the U.S. energy sector also saw increases.

Sector Update: Health Care Stocks Lower Premarket Monday

Health care stocks were lower premarket Monday, with the iShares Biotechnology ETF down 0.3% and the State Street Health Care Select Sector SPDR ETF down 0.5%. GH Research shares surged over 38% after the FDA lifted the clinical hold on its drug application for GH001. Novo Nordisk's stock rose more than 2% as it announced a $149 monthly price for its Wegovy weight loss drug. Gyre Therapeutics shares increased nearly 6% following an agreement for conditional approval of its liver fibrosis treatment in China.

Gyre Therapeutics, Inc. (NASDAQ:GYRE) Given Average Rating of "Hold" by Analysts

Gyre Therapeutics, Inc. (NASDAQ:GYRE) has received an average analyst rating of "Hold" from five firms covering the stock. The ratings include one sell, one hold, and three buy recommendations. The average target price is $17.00. Recent reports include Zacks upgrading from "strong sell" to "hold" and Jefferies initiating coverage with a "buy" rating at $16.00. The stock is currently priced at $6.81, with a 12-month range of $6.11 to $13.75. Institutional investors hold 23.99% of the stock, and the company focuses on developing therapies for metabolic and neurodegenerative diseases.