Stock Markets June 11, 2026 05:52 PM

Kyntra Bio Shares Climb After Roxadustat Post Hoc Analysis Shows Transfusion Benefits in LR-MDS

Post hoc results from the Phase 3 MATTERHORN study presented at EHA 2026 show improved transfusion independence with roxadustat and prompt plans for a pivotal trial

By Priya Menon
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Kyntra Bio (NASDAQ:KYNB) saw its stock rise in after-hours trading after the company presented a post hoc analysis from the Phase 3 MATTERHORN trial showing roxadustat increased durable red blood cell transfusion independence in patients with lower-risk myelodysplastic syndromes (LR-MDS) and a high transfusion burden. Data presented at the European Hematology Association Congress 2026 in Stockholm indicated similar responses in ring sideroblast positive and negative subgroups, and higher rates of 8-, 12- and 16-week transfusion independence in patients with heavier transfusion requirements. Kyntra said it is finalizing a pivotal Phase 3 protocol based on FDA feedback and expects to start the trial in the second half of 2026.

Kyntra Bio Shares Climb After Roxadustat Post Hoc Analysis Shows Transfusion Benefits in LR-MDS
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Key Points

  • Post hoc analysis from the Phase 3 MATTERHORN trial presented at EHA 2026 showed roxadustat improved durable transfusion independence versus placebo in LR-MDS patients with high transfusion burden.
  • Among ring sideroblast negative patients (84 of 140 enrolled), roxadustat produced at least 8 weeks of transfusion independence over 28 weeks in 48% of patients versus 28% for placebo.
  • Kyntra Bio is finalizing a pivotal Phase 3 trial protocol for roxadustat based on FDA feedback and expects to initiate the trial in the second half of 2026.

Kyntra Bio (NASDAQ:KYNB) shares rose 3.9% in after-hours trading Thursday after the company released a post hoc analysis indicating that roxadustat improved transfusion independence in patients with lower-risk myelodysplastic syndromes (LR-MDS) who carry a high transfusion burden.

The data were presented at the European Hematology Association Congress 2026 in Stockholm, Sweden, and derive from the Phase 3 MATTERHORN trial. In the analysis, patients treated with roxadustat demonstrated a durable improvement in transfusion independence when compared with placebo.

Examining disease subtypes, the post hoc assessment showed similar rates of transfusion independence for patients treated with roxadustat regardless of ring sideroblast status. Specifically, among the ring sideroblast negative subgroup - which made up 84 of the 140 patients enrolled in MATTERHORN - treatment with roxadustat produced transfusion independence for at least 8 weeks over a 28-week assessment period in 48% of patients, versus 28% for those receiving placebo.

For patients defined as having a high transfusion burden, the analysis applied the criterion of at least 4 units of packed red blood cells per 8-week period for two consecutive 8-week periods. Within this subgroup, roxadustat achieved higher rates of red blood cell transfusion independence at 8, 12, and 16 weeks compared with placebo.

Safety observations from the post hoc analysis indicated that treatment-emergent adverse events were generally lower grade and could be managed medically, with no new safety signals reported.

These subgroup and post hoc findings complement the initial MATTERHORN analysis, which showed that 48% of patients receiving roxadustat reached transfusion independence compared with 33% for placebo in the broader trial population.

Following the presentation, Kyntra Bio said it is finalizing the protocol for a pivotal Phase 3 trial of roxadustat specifically for the treatment of anemia in patients with LR-MDS and high transfusion burden. The company noted that the trial protocol reflects feedback from the U.S. Food and Drug Administration and that it expects to initiate the pivotal study in the second half of 2026.


Context and next steps

The company’s announced intention to move forward with a pivotal Phase 3 study signals a direct response to regulatory input and the subgroup findings reported at EHA 2026. The forthcoming trial is intended to further evaluate roxadustat’s efficacy and safety in the targeted LR-MDS population with significant transfusion needs.

Risks

  • The reported results come from a post hoc analysis, which can limit the strength of conclusions compared with pre-specified primary analyses.
  • Planned initiation of the pivotal Phase 3 trial is contingent on completion of protocol finalization and regulatory coordination, with an expected start in the second half of 2026 but no guaranteed date.
  • Treatment-emergent adverse events occurred and will need ongoing monitoring in the pivotal trial, even though the analysis reported events were generally lower grade and manageable with no new safety signals.

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