Fore Biotherapeutics wins ‘Breakthrough’ status for plixorafenib

2 April 2026

Precision oncology start-up Fore Biotherapeutics announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG).

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

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