FDA Grants Fast Track Designation to Cothera Bioscience’s Zotiraciclib for Treatment of Recurrent High-Grade Glioma with IDH1/2 Mutations

Breakthrough oral CDK9 inhibitor advances care for patients with recurrent high-grade gliomas harboring IDH1/2 mutationsFOR IMMEDIATE RELEASESan Mateo, CA and Bethesda, MD — November 26, 2025 — Cothera Bioscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to zotiraciclib (ZTR/TG02) for the treatment...

Cothera Bioscience Announces FDA Fast Track Designation for Clinical Program PC-002

San Francisco, California, October 14, 2024 — Cothera Bioscience, a leading biotech innovator advancing clinical stage therapeutics for previously undruggable oncology targets with high unmet medical needs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program PC-002, a...