FDA granted Orphan Drug Designation to AMXT 1501 in combination with difluoromethylornithine (DFMO) for the treatment of malignant glioma March 17, 2026
Positive CHMP opinion for Ojemda monotherapy for pediatric R/R BRAF-altered pediatric low-grade glioma March 10, 2026
FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma March 3, 2026
First IRB approval for APTN-101’s Ph 1 trial in GBM granted, enabling patient recruitment to begin January 25, 2026
Median OS Not Yet Reached and Lymphopenia Reversed in Recurrent GBM Patients Receiving ANKTIVA® Plus CAR-NK, Chemo-Free Therapy January 25, 2026
Encouraging Clinical Results with In Situ Conversion Therapy NXL-004 for Malignant Glioma Reported December 22, 2025
Additional Positive LP-184 Ph 1a Results Reported Showing Durable Disease Control in Heavily Pre-Treated Advanced Cancer Patients December 9, 2025
Preliminary Ph 2 Data for Silevertinib in 1L NSCLC and Plans for Ph 2 Trial of Silevertinib in GBM Announced December 9, 2025
Update from ongoing TEM-GBM study in newly diagnosed GBM patients with an unmethylated gene promoter announced December 2, 2025
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
