Forte Biosciences' FB102 Receives FDA Fast Track Designation
"FB102 received Fast Track Designation from the FDA in celiac disease, highlighting the unmet need and reinforcing FB102's potential to address the high unmet need in celiac disease. The clinical development for FB102 continues to progress well with important readouts coming shortly," said Forte Biosciences CEO Paul Wagner, PhD. "The topline results from our phase 2 celiac disease study are expected in 2026. Based on the strength of the positive results from the FB102 phase 1b CeD trial, which we reported in June 2025, we look forward to the phase 2 data further validating FB102 for the treatment of celiac disease. The FB102 phase 1b vitiligo clinical study is expected to have topline results shortly and the alopecia areata phase 1b data readout is expected in 2026. We remain very optimistic about FB102's potential to address the significant unmet medical needs across multiple indications representing what we believe to be multi-billion-dollar potential market opportunities."