FORE-8394 is under clinical development by Fore Biotherapeutics and currently in Phase II for Glioma. According to GlobalData, Phase II drugs for Glioma have a 23% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how FORE-8394’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

FORE-8394 overview

FORE-8394 (PLX-8394) is under development for the treatment of solid tumors, high grade glioma, anaplastic astrocytoma, high grade astrocytoma with piloid features, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma and glioblastoma multiforme. The drug candidate is a next-generation small molecule administered orally. The drug candidate targets BRAF.

It was under development for hairy cell leukemia, advanced malignancies, pilocytic astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, astrocytoma, papillary craniopharyngioma, glioblastoma and other leukemias. 

Fore Biotherapeutics overview

Fore Biotherapeutics, formerly known as NovellusDx, is a precision oncology company that focuses on the development of its lead program FORE8394 (formerly PLX-8394) platform, a next generation treatment for class I or II BRAF mutations and fusions, V600 and non-V600 BRAF mutations. FORE8394 is a small molecule that only targets cancer cells with a mutated BRAF gene. The company employs functional genomics to develop treatments that improve the lives of patients suffering from rare cancers. It develops treatments for patients with cancers that are genetically defined. Fore Biotherapeutics is headquartered at Philadelphia, Pennsylvania, the US.

For a complete picture of FORE-8394’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.