# Fore Biotherapeutics

> Fore Biotherapeutics is a Philadelphia-based, registration-stage precision oncology company developing targeted therapies for patients with hard-to-treat cancers. Its lead candidate, plixorafenib, is a next-generation BRAF inhibitor (a 'dimer breaker') aimed at BRAF-altered solid tumors, including BRAF V600E-mutated high-grade glioma, for which it received FDA Breakthrough Therapy Designation in 2026. Spun out of the Israeli functional-genomics company NovellusDx, Fore has raised more than $200M to push plixorafenib toward an accelerated FDA approval pathway.

- **Founded:** 2011
- **Headquarters:** Philadelphia, United States
- **Founders:** Michael Vidne (Co-founder / former CEO (NovellusDx era))
- **Team size:** ~55 employees
- **Products:** Plixorafenib (FORE8394), FORTE clinical trial program, Functional genomics platform (legacy)
- **Notable:** Received FDA Breakthrough Therapy Designation for plixorafenib in BRAF V600E-mutated high-grade glioma (April 2026) - believed to be the first BTD for a targeted therapy in HGG., Reported a 67% overall response rate in a pre-specified subgroup of MAPK-inhibitor-naive BRAF V600-mutated primary CNS tumors in the Phase 1/2a trial., Raised more than $200M in total funding to advance a single lead asset toward registration.

## Products & services

- **Plixorafenib (FORE8394)** — Lead investigational program: a next-generation, highly selective small-molecule BRAF inhibitor described as a 'dimer breaker.' It targets Class I/V600 and Class II BRAF alterations across solid tumors, including BRAF V600E-mutated high-grade glioma and other primary CNS tumors. Granted FDA Breakthrough Therapy Designation in April 2026.
- **FORTE clinical trial program** — Phase 2 basket trial (FORTE) evaluating plixorafenib monotherapy in patients with recurrent or progressive BRAF V600 primary CNS tumors and other BRAF-altered solid tumors. Topline CNS basket results expected by end of 2026.
- **Functional genomics platform (legacy)** — Originally developed under NovellusDx; a platform to functionally characterize tumor mutations, which the company used to identify and prioritize drug-development opportunities before pivoting fully to therapeutics.

## Achievements

- Received FDA Breakthrough Therapy Designation for plixorafenib in BRAF V600E-mutated high-grade glioma (April 2026) - believed to be the first BTD for a targeted therapy in HGG.
- Reported a 67% overall response rate in a pre-specified subgroup of MAPK-inhibitor-naive BRAF V600-mutated primary CNS tumors in the Phase 1/2a trial.
- Raised more than $200M in total funding to advance a single lead asset toward registration.
- Successfully pivoted from a diagnostics/functional-genomics company (NovellusDx) into a registration-stage therapeutics company.

## Latest updates

- **2026-04** — FDA granted plixorafenib Breakthrough Therapy Designation for BRAF V600E-mutated high-grade glioma.
- **2025-05** — Closed $38M Series D-2 financing to expedite plixorafenib development; CEO signaled plans to file for FDA approval and pursue additional funding.
- **2023-08** — Announced $75M Series D financing and a CEO transition.

## Links

- Website: https://fore.bio
- LinkedIn: https://www.linkedin.com/company/forebiotherapeutics
- Twitter/X: https://twitter.com/forebiotx

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Profile page: https://yespress.io/fore-biotherapeutics
Published by YesPress — https://yespress.io
Last updated: 2026-06-15