GYREGyre Therapeutics, Inc.
The Read
7% following a well-executed equity raise, but dropped nearly 10% again when China’s NMPA delayed F351 approval and Q1 revenue missed estimates.
The schedule
- Mon5Oct
Market evaluation of President Trump's administration policies regarding US-listed Chinese biotech operations.
- Thu22Oct
Anticipated final decision from China's NMPA on the New Drug Application for F351 in liver fibrosis.
- Tue15Dec
Mid-stage clinical data presentation for F573 in acute liver failure.
- Mon8Feb
Q3 report focusing on initial commercialization strategies and forward SG&A spending plans.
- Sun14Feb
Q4 results delivering the first concrete updates on early Hydronidone launch metrics.
- Sun16May
Q1 print assessing whether the revenue run-rate supports full-year internal estimates.
Past
- Mon10Aug
Actual outcome: Bull
Gyre Therapeutics reported Q2 2026 revenue of $29.1 million and affirmed its full-year revenue guidance of $100.5 to $111.0 million. Despite a slight EPS miss, the reaffirmed guidance and the recent acceptance of the NDA for F351 (hydronidone) by China's CDE provided positive commercialization momentum. This steady outlook and continued progress on its key pipeline asset drove the stock to exceed the bull target.
Quarterly earnings focusing on cash burn and commercialization prep for Hydronidone after previous guidance cuts.
- Mon20Jul
Actual outcome: Mixed · $5.85 at outcome
Gyre's stock saw a muted initial reaction around the expected competitor MASH/NASH data readout window, but shares subsequently rallied to approach the bull target by early August. In the absence of negative sector readthroughs, the market ultimately responded positively to the company's broader strategic positioning, highlighted by the recent appointment of three new board members to help guide its clinical pipeline.
Expected readout from a major peer in the MASH/NASH space, which acts as a sector proxy for Gyre's own Hydronidone (F351) pipeline.
- Fri15May
Actual outcome: Bear · $5.91 at outcome
Gyre Therapeutics announced that China's NMPA accepted the New Drug Application for F351 (hydronidone), initiating the review process rather than delivering the anticipated conditional approval decision. This regulatory timeline update, coupled with a recent Q1 earnings report that missed revenue estimates, disappointed investors and drove the stock down 9.8% toward the bear floor.
China NMPA’s conditional approval decision for hydronidone (F351) is a binary regulatory catalyst; a positive outcome could re-rate Gyre Therapeutics toward $9.60 on commercialization visibility, while a delay or rejection could compress the stock toward $9.60.
- Wed15Apr
Actual outcome: Bull · $7.35 at outcome
Gyre Therapeutics executed its anticipated equity offering to secure the necessary cash runway ahead of hydronidone commercialization. Although shares initially dipped on the dilution, the deal avoided a deeply discounted structure, alleviating worst-case bear scenarios. The market ultimately rewarded the improved balance sheet clarity, allowing the stock to recover and approach the $7.50 bull target.
Potential follow-on equity raise around $7.09 to extend the cash runway ahead of hydronidone commercialization; a well-structured deal could modestly re-rate shares toward $7.50, while a deeply discounted or upsized raise risks driving the stock down toward $7.50.
- Fri13Mar
Actual outcome: Bear · $6.94 at outcome
Gyre Therapeutics reported a Q4 earnings miss and issued weak full-year 2026 revenue guidance of $100.5 to $111.0 million, forecasting a year-over-year decline from 2025's $116.6 million. Although the company secured a positive regulatory milestone with China's NMPA granting Priority Review for its F351 NDA, the disappointing financial results and soft forward revenue outlook overshadowed the clinical progress, driving the stock down toward the bear floor.
Fiscal year-end report with critical focus on cash runway and progress updates for the F351 regulatory filing in China.
