FORE Biotherapeutics (fore.bio), a precision oncology company, has raised $67.4 million in a Series D-2 extension financing co-led by SR One, Medicxi, and SymBiosis. The company is advancing plixorafenib, a next-generation oral BRAF inhibitor designed to target both V600 and non-V600 BRAF alterations as a monotherapy. The capital will support late-stage development of plixorafenib through its registrational FORTE Phase 2 basket trial.
Precision Oncology Momentum Builds
The funding arrives as the precision oncology market expands from $133.06 billion in 2026 to $317.16 billion by 2034 at an 11.47% CAGR, according to Fortune Business Insights. The BRAF kinase inhibitors segment is projected to grow from $2.12 billion in 2026 to $3.52 billion by 2033 at an 8.3% CAGR, per Coherent Market Insights. Recent activity includes Nuvalent's acquisition by GSK for $10.6 billion in June 2026. FORE's plixorafenib differentiates by acting as both a paradox breaker and dimer breaker, enabling single-agent use without MEK inhibitor combinations required by earlier BRAF drugs.
High-Grade Glioma Treatment Gaps Persist
Patients with BRAF V600E-mutated high-grade glioma face poor outcomes despite multimodality treatment. First-generation BRAF inhibitors like vemurafenib and dabrafenib trigger paradoxical MAPK pathway activation, leading to resistance and requiring toxic MEK inhibitor combinations with discontinuation rates of 10-15%. Non-V600 mutations and fusions remain largely unaddressed by current therapies.
Dual-Mechanism BRAF Inhibitor Advances
Plixorafenib (FORE8394) inhibits Class I V600 monomers and Class II dimers/fusions while avoiding paradoxical activation. Phase 1/2a data showed 67% objective response rate and over 75% clinical benefit rate in MAPK inhibitor-naïve BRAF V600 primary CNS tumors. The drug achieved a median duration of response of 17.8 months in V600-altered patients and a 64-month median progression-free survival in thyroid cancer. Drug-related adverse event discontinuation stayed below 2%.
As Stacie Peacock Shepherd, MD, PhD, CMO noted:
"This is the first BTD granted to a targeted therapy for patients with HGG and recognizes plixorafenib's potential to provide substantial improvement over currently available therapies."
Series D-2 Extension Validates Program
The upsized round brings total Series D-2 to $110 million and overall Series D to $113 million. Existing investors including OrbiMed, HBM Healthcare, Wellington Management, Novartis Venture Fund, and Samsung participated alongside new backers TaiAx, LG Technology Ventures, Primer Ventures, and Axil. The financing follows FDA Breakthrough Therapy Designation in April 2026, the first for any targeted therapy in high-grade glioma.
BRAF Market Expands Beyond Melanoma
FORE targets multi-billion-dollar opportunities in BRAF-altered CNS tumors and other solid tumors. Competitors include Day One Biopharmaceuticals with approved tovorafenib for pediatric low-grade glioma and Erasca advancing broader MAPK pathway inhibitors. The company's virtual biotech model, licensing clinic-ready assets, supports capital-efficient execution toward a potential 2027 NDA submission.
Topline Data Expected End of 2026
Target enrollment of approximately 50 patients was reached in the BRAF V600E primary CNS tumor basket of the FORTE study. Topline results are anticipated around the end of 2026, with potential NDA submission under the Accelerated Approval pathway in 2027. The company also simplified dosing by eliminating the need for cobicistat after a food-effect study and lowered the minimum trial age to 8 years.