08/07/2026 New independent-statistician analyses show DCVax-L survival benefit was underestimated New independent-statistician analyses show DCVax-L survival benefit was underestimated (Ref) Northwest Biotherapeutics presented updated survival data from the Phase 3 trial of DCVax®-L (dendritic cell-based vaccine) for glioblastoma (GBM) at the 2026 BNOS meeting. Survival benefit of DCVax-L was likely underestimated in the original trial analysis New analyses used individual pa

17/03/2026 CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma Voro Therapeutics and Daiichi Sankyo sign a research collaboration for Next-Generation Tumor-Activated ADCs Myriad Genetics' MyChoice CDx test received FDA approval as the companion diagnostic for Zejula CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma (Ref) The US FDA granted the Orphan Drug Designation to CRISM Therapeutics Corporation's irinotecan for the treatment o

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC (Ref) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by the

October 5th Week, 2025 Regulatory Events 🎯 The EC approved Merck & Co./ MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of LA SCCHN? Clinical Events 🔬 Merck & Co./MSD and Eisai US reported that the Phase 3 LITESPARK-011 trial of belzuti

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab entered a licensing agreement with JMT-Bio Technology (a wholly-ow

07/10/2025 Precision NeuroMed's cinetredekin besudotox received the FDA orphan drug designation for GBM (Ref) The US FDA granted the orphan drug designation to Precision NeuroMed's cinetredekin besudotox (IL13PE38 ; cytotoxic protein) for the treatment of glioblastoma (GBM). The advanced convection-enhanced delivery (CED) platform delivers therapeutic concentrations of cinetredekin besudotox to tumor-infiltrated regions of the brain Sandeep Kunwar, CEO and Co-Founder, Precisi

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM (Ref) The US FDA granted the Orphan Drug Designation to Beyond Air's BA-101 for the treatment of Glioblastoma (GBM). Amir Avniel, CEO, NeuroNOS: “We are pleased to receive orphan drug designation from the FDA for the treatment of glioblastoma. This is our second orphan drug designation and further highlights our mission to bring targeted therapies to individuals and families affected by rare neurologi

Welcome to the April edition of our CGT Watch newsletter! Autolus’ Aucatzyl’s UK approval; BrainChild Bio’s BCB-276 BTD; Lyell’s LYL314 RMAT designation; TScan’s Ph1 trial update; CERo’s IND approval; CARGO's assets discontinuation; Carisma assessing strategic alternatives; BioNtech co-development option expiration; Caribou Bio restructuring. Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear R