Kyntra Bio exits China, repays debt, advances FG-3246 and roxadustat MDS programs

Filed March 16, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 17, 2025 · ~1 min read

Key Changes

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  Completed sale of China operations to AstraZeneca for $220.4M (Aug 2025), used proceeds to fully repay $75M Morgan Stanley term loan, eliminating debt and resolving prior going-concern doubt.

  Business / MD&A: China Divestiture verify on EDGAR →
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  Initiated Phase 2 trial of FG-3246 for metastatic prostate cancer (Q3 2025); interim analysis planned H2 2026. Combination trial data showed 40% response rate in single-prior-ARPI patients.

  Business: FG-3246 Development verify on EDGAR →
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  Reached FDA alignment on Phase 3 roxadustat trial design for MDS (July 2025), submitted protocol (Dec 2025), and received Orphan Drug Designation providing 7-year exclusivity if approved.

  Business: Roxadustat MDS verify on EDGAR →