1 April 2026 - Fore Biotherapeutics today announced that the US FDA has granted breakthrough therapy designation to plixorafenib for the treatment of adult patients with BRAF V600E mutated high grade glioma. 

Fore Bio believes this is the first breakthrough therapy designation granted to a targeted therapy for high grade glioma. Plixorafenib is a novel BRAF inhibitor that is a dimer breaker with high selectivity for BRAF alterations.

Read Fore Biotherapeutics press release