News & Events zu Kyntra Bio Inc (KYNB)KYNBKyntra Bio Inc

Kyntra Bio CEO Emphasizes Advancing Clinical Trials

"We continue to make progress across our oncology and rare disease portfolio and remain laser-focused on advancing toward our goal of initiating a pivotal Phase 3 trial of roxadustat in LR-MDS in the fourth quarter of this year and conducting an interim analysis of the Phase 2 trial of FG-3246 in mCRPC, also in the fourth quarter of this year," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "We believe we have the substrate that will enable us to create significant value for patients and stakeholders as we advance our pipeline and look forward to providing additional updates in the coming months."

Kyntra Bio Presents Roxadustat Study Data at EHA 2026

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 treated with roxadustat will be presented as a poster at the European Hematology Association, or EHA, Congress 2026, taking place June 11-14 in Stockholm, Sweden. 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. 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 greater than or equal to 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 who met the criteria of HTB per IWG-2018, where roxadustat achieved clinically meaningful efficacy in patients with LR-MDS and HTB with higher rates of greater than or equal to 8-, 12-, 16-week RBC TI vs placebo. TEAEs were generally lower grade and managed medically with no new safety signals. The poster presentation is scheduled for the poster session taking place on June 12. 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.

Kyntra Bio to Present FG-3246 Data at ASCO GU Conference

The company states: "Kyntra Bio (KYNB), formerly FibroGen (FGEN), announced that the data on anti-tumor activity of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) from the investigator-sponsored Phase 1b/2 study will be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026 in San Francisco, CA. The presentation includes data from 44 biomarker unselected patients with progressive metastatic castration-resistant prostate cancer, 17 of which were enrolled in the Phase 1b dose escalation portion of the study. Eligibility criteria for the trial included patients who progressed on at least one prior ARPI while patients who were treated with prior chemotherapy in the castration-resistant setting were excluded. Over 60% of the patients progressed on two or more prior ARPIs, which included prior enzalutamide treatment. The primary endpoint of the escalation phase was assessment of dose-limiting toxicities and determination of the maximum tolerated dose and recommended dose for the Phase 2 portion of the study - which was determined to be 2.1 mg/kg of FG-3246 and 160 mg/day of enzalutamide. The primary endpoint of the Phase 2 expansion portion of the study was composite response rate (PSA50 response and/or objective response per RECIST v1.1). Secondary endpoints were PSA50 response rate, objective response rate, radiographic progression free survival (rPFS), overall survival, and treatment-related adverse events (TRAEs)."