GYRE
Gyre Therapeutics, Inc.7.58
+0.04+0.53%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
No earnings call transcript available
Key Stats
Market Cap
730.21MP/E (TTM)
189.50Basic EPS (TTM)
0.04Dividend Yield
0%Recent Filings
10-K
FY2025 results
Gyre Therapeutics posted FY2025 revenue of $116.6M, up 10% y/y, driven by $106.1M from ETUARY® (91% of total), plus launches of Etorel® ($4.6M) and Contiva® ($5.5M); yet ETUARY®'s IPF share slipped amid rivals like OFEV®. Q4 momentum built on new product ramps, but no quarterly breakdowns disclosed. Gross margins held firm at 95%, funding R&D ($13.7M, +14%) for Hydronidone's NDA (H1 2026) after Phase 3 fibrosis win and U.S. Phase 2 prep. Cash swelled to $37M post-equity raises. Merger with Cullgen pends HSR. PRC regulatory flux risks pipeline momentum.
8-K
Q4 results, Cullgen acquisition
Gyre Therapeutics posted full-year 2025 revenue of $116.6 million, up 10% from 2024, fueled by launches of Etorel® ($4.6M) and Contiva® ($5.5M). It inked a $300M all-stock deal to buy Cullgen, closing Q2 2026, adding protein degradation tech. Hydronidone NDA for conditional China approval hits H1 2026. Revenue guides $100.5-$111M for 2026. Acquisition expands pipeline, yet revenue dips ahead.
8-K
Gyre projects big fibrosis revenues
Gyre Therapeutics presented at an investor conference on March 10, 2026, projecting ~$400-600M revenues in 5 years for Hydronidone in liver fibrosis and ~$100M sustained for ETUARY in lung fibrosis absent generics. Cullgen validated CG001419 safety at 400mg in Australia, with US Phase 2 enrolling for ~95% TRK degradation. Forward-looking estimates carry risks per SEC filings.
8-K
Gyre acquires Cullgen for $300M
Gyre Therapeutics signed a merger agreement on March 2, 2026, to acquire Cullgen in an all-stock deal valuing Cullgen at $300 million, making it a wholly owned subsidiary pending Cullgen stockholder approval and HSR clearance. Cullgen's targeted protein degradation pipeline bolsters Gyre's fibrosis assets like marketed ETUARY. Ying Luo steps in as CEO post-close. Deal caps stock issuance at 19.99% pre-conversion vote.
8-K
Hydronidone gains China approval path
Gyre Therapeutics' China subsidiary completed a Pre-NDA meeting with CDE on January 5, 2026, securing alignment for conditional NDA approval of Hydronidone in CHB-associated liver fibrosis using existing Phase 3 data—52.85% fibrosis regression vs. 29.84% placebo. Priority review eligibility confirmed. NDA submission slated for H1 2026, followed by confirmatory trial. Execution risks loom.
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