Fore Biotherapeutics has closed an upsized $67.4 million Series D-2 extension financing to support the continued development of plixorafenib, its lead targeted oncology candidate. The latest financing brings the company’s total Series D-2 raise to $110 million, strengthening its balance sheet as it advances toward key clinical and regulatory milestones. The Philadelphia-based company said the funding will help support late-stage development activities, upcoming topline data, and a planned regulatory submission for BRAF V600E primary central nervous system tumors.
Financing Details
The financing was co-led by SR One, Medicxi, and SymBiosis, with participation from new investors including TaiAx, LG Technology Ventures, Primer Ventures, and Axil. Existing investors also backed the round, including OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung, and 3B Capital. Fore said the expanded investor support reflects confidence in plixorafenib’s potential to address major treatment gaps in BRAF-altered cancers.
Advancing Plixorafenib
Plixorafenib is a novel BRAF inhibitor designed to target both V600 and non-V600 BRAF alterations through a differentiated mechanism of action. The drug is being developed as a monotherapy for several difficult-to-treat cancer populations, including recurrent or progressive BRAF V600E primary CNS tumors, rare BRAF V600 mutated solid tumors, and advanced solid tumors with BRAF fusions. Fore believes the candidate could improve on earlier generations of BRAF inhibitors by addressing limitations that have historically contributed to disease recurrence and the need for combination therapy.
FORTE Study Progress
The company said target enrollment of approximately 50 patients has been reached in the BRAF V600E CNS tumor basket of the global Phase 2 FORTE study. Topline results from this registrational basket are expected around the end of 2026, following a previously positive interim analysis reviewed by an Independent Data Monitoring Committee. If the primary analysis is positive, Fore expects the data could support a New Drug Application submission to the FDA through the Accelerated Approval pathway.
Clinical and Regulatory Updates
Fore also reported protocol updates intended to broaden access and simplify treatment within the FORTE study. The company has received clearance to enroll patients as young as eight years old, lowering the previous minimum age of 10 to better reflect the patient population affected by BRAF-altered CNS tumors. It has also revised the dosing approach so plixorafenib can be administered with food, while removing cobicistat from the regimen based on recent food-effect and clinical exposure data.
Development Outlook
Plixorafenib received Breakthrough Therapy Designation from the FDA in April 2026, adding regulatory momentum to Fore’s late-stage development program. Earlier clinical data showed encouraging response rates and a favorable tolerability profile across tumor types, supporting the company’s decision to continue evaluating the therapy across multiple BRAF-driven indications. Fore expects to advance through several clinical and regulatory milestones during 2026 and 2027 as it works to bring plixorafenib closer to patients with limited treatment options.
The upsized financing gives Fore Biotherapeutics additional resources at a critical point in the development of its lead oncology asset. With target enrollment complete in the primary CNS tumor basket and topline data expected around the end of 2026, the company is approaching a major validation point for plixorafenib. A successful readout could position Fore to pursue a 2027 FDA submission and further establish plixorafenib as a potential new option for BRAF-altered cancers.