Announcement • Jun 13

Kyntra Bio Presents New Roxadustat Data on Improvements in Transfusion Independence in Patients with Anemia Due to Lower-Risk Myelodysplastic Syndromes

Kyntra Bio announced additional data from the Phase 3 MATTERHORN trial showing improvements in transfusion independence in patients with anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) treated with roxadustat will be presented as a poster at the European Hematology Association (EHA) Congress 2026, taking place June 11-14, 2026 in Stockholm, Sweden. In a post hoc analysis, patients treated with roxadustat showed a durable and clinically meaningful improvement in transfusion independence (TI) in patients with LR-MDS and high transfusion burden (HTB) compared to placebo. Similar rates of TI for patients treated with roxadustat were observed in both ring sideroblast positive (RS+) and ring sideroblast negative (RS-) disease. Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the Food and Drug Administration (FDA). As previously disclosed, the initial analysis with all of the patients who participated in the Phase 3 MATTERHORN trial showed that more patients receiving roxadustat achieved transfusion independence vs. placebo (48% vs. 33%; p=0.22). The presentation highlights data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS- patients. In RS- patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for =8 weeks over 28 weeks in 48% of patients vs. 28% for placebo. The presentation at EHA also provides additional details on the subgroup of patients (n=37) who met the criteria of HTB (= 4 units pRBCs per 8-week period for 2 consecutive 8-week periods) per IWG-2018, where roxadustat achieved clinically meaningful efficacy in patients with LR-MDS and HTB with higher rates of =8-, 12-, 16-week RBC TI vs placebo. TEAEs were generally lower grade and managed medically with no new safety signals. The poster presentation, titled “Roxadustat improves transfusion independence in LR-MDS patients with anemia and high transfusion burden and in ring sideroblast positive and negative disease: post-hoc analysis of MATTERHORN study” is scheduled for the poster session taking place on June 12, 2026 at 18:45 CEST. The pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA. Roxadustat (also known as FG-4592, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker.

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Kyntra Bio Presents New Roxadustat Data on Improvements in Transfusion Independence in Patients with Anemia Due to Lower-Risk Myelodysplastic Syndromes

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