"Baudax Bio's TI-168 Receives FDA Orphan Drug Designation for Hemophilia A with Inhibitors"

Baudax Bio has announced that the U.S. FDA has granted orphan drug designation to its lead clinical candidate, TI-168, for the treatment of Hemophilia A with inhibitors. TI-168 is a next-generation T cell receptor therapy designed to address Hemophilia A patients with FVIII inhibitors. The designation provides various benefits to support the development of novel drugs, including potential market exclusivity for seven years upon FDA approval. Baudax Bio plans to activate the Phase 1/2a clinical trial of TI-168 in early 2024.