FORE Biotherapeutics, a registration-stage oncology company focused on targeted cancer therapies, announced the closing of an upsized $67.4 million Series D-2 extension financing, bringing the total raised in the Series D-2 round to $110 million.
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, alongside existing investors such as OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung, and 3B Capital.
The company will use the proceeds to advance the late-stage development of its lead drug candidate, plixorafenib, including generating topline data from the recurrent or progressive BRAF V600E primary CNS tumor basket of the Phase 2 FORTE study by the end of 2026, preparing for a regulatory submission, and continuing development in additional BRAF-driven solid tumor indications.
Alongside the financing announcement, FORE Biotherapeutics provided several updates on the plixorafenib program. The company has completed enrollment of approximately 50 patients in the BRAF V600E primary CNS tumor basket of the FORTE study, keeping it on track to report topline results around the end of 2026. If successful, the data could support a New Drug Application submission to the U.S. Food and Drug Administration under the Accelerated Approval pathway.
The Independent Data Monitoring Committee (IDMC) also approved expanding enrollment to patients as young as eight years old, compared with the previous minimum age of 10, reflecting the prevalence of BRAF-altered CNS tumors among pediatric and young adult patients.
FORE also updated the FORTE study protocol to administer plixorafenib with food, following positive findings from a food-effect study. As a result, cobicistat, which had previously been used as a pharmacokinetic booster, will no longer be administered alongside the therapy.
Beyond the CNS tumor program, the company continues to evaluate plixorafenib in two additional monotherapy cohorts targeting rare BRAF V600-mutated solid tumors and advanced solid tumors with BRAF fusions. FORE expects multiple clinical and regulatory milestones throughout 2026 and into 2027.
Plixorafenib received the FDA’s Breakthrough Therapy Designation in April 2026. The investigational BRAF inhibitor is designed with a novel mechanism of action to overcome the limitations of earlier-generation BRAF therapies and has demonstrated encouraging efficacy and safety across multiple tumor types in clinical studies.
KEY QUOTES:
“We are pleased with the progress at Fore this year, which allowed us to expand our investor base with new, quality healthcare investors and are grateful for the continued support from all our existing investors, which reflects their confidence in the potential for plixorafenib to disrupt the BRAF market. With target enrollment now complete in the primary CNS tumor basket, we look forward to reporting topline data from this basket around the end of 2026. With the recent Breakthrough Therapy Designation granted to plixorafenib, we continue to progress towards a planned regulatory submission in 2027 for BRAF V600E CNS tumors and bringing this novel mechanism and differentiated profile to patients who are in need of improved therapeutic options.”
— William Hinshaw, Chief Executive Officer of FORE Biotherapeutics
“With several key clinical and regulatory catalysts on the horizon, we believe plixorafenib has the potential to meaningfully improve upon the current treatment paradigm, representing a significant opportunity across several BRAF-altered CNS tumor types including high and low grade glial and glioneuronal brain and spinal cord tumors, glioblastomas, and others, in addition to the distinct patient populations currently being evaluated in the FORTE study.”
— William Hinshaw, Chief Executive Officer of FORE Biotherapeutics
