FDA grants Fast Track Designation for Ofirnoflast (HT-6184) in Lower-Risk MDS
“Receiving Fast Track designation is an important milestone for Halia and reflects the significant unmet need that remains for patients with lower-risk MDS,” said David J. Bearss, Ph.D., Chief Executive Officer of Halia Therapeutics. “The designation follows encouraging Phase 2 results demonstrating durable transfusion independence and multilineage hematologic improvement and provides an important opportunity to work closely with the FDA as we advance ofirnoflast toward pivotal development. Patients who no longer respond to erythropoiesis-stimulating agents or erythroid maturation agents often face limited options and a substantial burden from chronic anemia and transfusion dependence.”
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