Positive Outcome Announced from First Planned Interim Efficacy Analysis from FORTE Basket Study of Plixorafenib Monotherapy in Advanced Solid Tumors with BRAF Fusions

William Hinshaw, Chief Executive Officer of Fore, commented, “Plixorafenib is emerging as a potential first-in-class and best-in-class next-generation BRAF inhibitor with a simple, once daily, oral dosing regimen without the PK booster cobicistat. At Fore Bio, we initiated studies in three areas of very high unmet need where we believe plixorafenib’s unique mechanism has the potential to add important clinical innovation and benefit for patients while getting to market as rapidly as possible, including in BRAF V600E central nervous system (CNS) tumors, BRAF fusions and rare BRAF V600E solid tumors. Plixorafenib has demonstrated activity across a wide number of tumors with BRAF alterations and has now passed two rigorous interim analyses, one for BRAF V600E CNS tumors and one for tumors with BRAF fusions, both encouraging milestones for the FORTE program. As we look ahead to the remainder of 2026 and into next year, we expect to achieve several important milestones, including reporting topline results from the BRAF V600E CNS basket around the end of 2026, submitting an NDA for the treatment of BRAF V600E CNS tumors during the first half of 2027, and reporting topline results from the BRAF fusion basket during the second half of 2027.”