FDA Alignment on use of PFS as Primary Endpoint in Ph 3 VERSATILE-003 Trial Announced January 11, 2026
Breakthrough Therapy Designation in the US and China for sevabertinib in 1L HER2-mutant NSCLC January 11, 2026
Breakthrough Therapy Designation granted to zoldonrasib for previously treated KRAS G12D-mutated locally advanced or metastatic NSCLC January 11, 2026
IND application submitted to FDA for ALA-101 allogeneic CAR-iNKT cell therapy targeting CD19-positive NHL and leukemias January 4, 2026
Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) + Pembrolizumab for 1L PD-L1-Positive NSCLC January 4, 2026
NDA for savolitinib for locally advanced/metastatic GC/GEJ adenocarcinoma patients with MET amplification accepted and granted priority review by the China NMPA December 30, 2025
Enhertu granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer December 30, 2025
Positive Scientific Advice from EMA on the Design of a Ph 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Announced December 30, 2025
CTA submitted in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101) for Solid Tumors December 22, 2025
IND Application to Initiate a Ph 1 Trial of ABP-102/CT-P72 for HER2-positive Cancers submitted to the US FDA December 22, 2025
Successful Type C Meeting with US FDA Regarding Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Announced December 22, 2025
TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program December 22, 2025
FDA approves IND to start a Ph 1/2 trial for PM54 + immunotherapy combo in advanced solid tumors December 22, 2025
