FDA Grants Fast Track Designation to Zotiraciclib for Treatment of Recurrent High-Grade Glioma with IDH1/2 Mutations December 2, 2025
Ph 3 STELLAR clinical study results showing clinically meaningful benefits with eflornithine + lomustine in patients with grade 3 astrocytoma November 24, 2025
Following discussion with FDA, safusidenib vs vorasidenib trial in grade 2 IDH1-mutant glioma cancelled November 10, 2025
Positive Findings from Longer-Term Analysis of Ph 3 INDIGO Trial Showing Continued Durable Benefit of VORANIGO® (vorasidenib) Published in The Lancet Oncology November 10, 2025
Rare Pediatric Disease Designation from FDA for Iopofosine I 131 in R/R Pediatric High-Grade Glioma October 29, 2025
Type C meeting with FDA requested to discuss OS findings in 1L GBM patients treated with paxalisib and to discuss potential regulatory pathway per OCE’s Project FrontRunner initiative October 29, 2025
Positive Outcome From FORTE Basket Study of Plixorafenib Monotherapy in Recurrent or Progressive BRAF V600 Primary CNS Tumors Announced October 21, 2025
Cinetredekin besudotox Granted FDA Orphan Drug Designation by US FDA for Treatment of GBM October 16, 2025
ASTRO 2025: Final Results from Pivotal Ph 3 METIS Trial of TTFields Therapy for Brain Mets from NSCLC presented October 8, 2025
OmniaBio Inc. and BrainChild Bio Announce Collaboration to Accelerate CAR-T Cell therapy Development in Brain Cancer October 7, 2025
Tinostamustine included in Ph 2/3 GBM AGILE adaptive clinical trial for GBM patients September 23, 2025
Patients With Aggressive Brain and Advanced Liver Cancers Treated with PIC monotherapy Reach Five Years of Durable RFS September 23, 2025
European Commission Approves VORANIGO® (vorasidenib) for Grade 2 IDH-Mutant Glioma September 23, 2025
Initial Data Shows 100% Disease Control in all 5 Recurrent GBM patients and Near CR in 2, Treated With ANKTIVA® + Optune Gio® Device September 3, 2025
NeOnc Technologies Awarded $2.5M in NIH STTR Grants to Advance NEO212 in Gliomas and Leukemia in Ph 2 trials August 12, 2025
U.S. FDA Approves Modeyso™ (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma August 11, 2025
