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FDA grants Fast Track designation for TX2100 to treat Hereditary Hemorrhagic Telangiectasia, clearing way for Phase 1b trial
TECXTectonic Therapeutic, Inc.
Tectonic Therapeutic announced favorable Phase 1a safety, tolerability, and pharmacokinetic results for TX2100 in healthy volunteers. The U.S. FDA granted Fast Track designation for TX2100 to treat Hereditary Hemorrhagic Telangiectasia (HHT) and cleared the Investigational New Drug application for a Phase 1b trial. The company plans to initiate an open-label Phase 1b trial by year-end 2026 and a Phase 2 trial in early 2027. Tectonic Therapeutic is a clinical-stage biotechnology company focused on discovering and developing therapeutic proteins and antibodies that modulate G-protein coupled receptors.