FDA grants Orphan Drug Designation Granted to NP-G2-044 for the Treatment of Pancreatic Cancer January 18, 2026
BLA submitted to US FDA Seeking Approval for Ivonescimab + chemo Combo in 2L+ EGFRm NSCLC January 18, 2026
FDA Alignment Received on Registrational Studies Design for NDV-01 for 2L refractory high-grade NMIBC and in intermediate-risk NMIBC in the adjuvant setting January 18, 2026
IND application submitted for GTB-5550 TriKE for B7-H3 expressing solid tumor cancers January 18, 2026
Regulatory Clearances of IND Applications for CR-001 & CR-003 for the Treatment of Solid Tumors Announced January 11, 2026
FDA Grants Orphan Drug Designation to CK0804 Treg Therapy for Treatment of Myelofibrosis January 11, 2026
FDA “Study May Proceed” Letter for (Z)-Endoxifen IND Application for Metastatic Breast Cancer Received January 11, 2026
Successful Pre-IND FDA Meeting and Continued Progress Toward First-in-Human Trial of ERNA-101 in Ovarian Cancer Announced January 11, 2026
FDA Fast Track Designation for ETX-19477 for BRCA-Mutated, Platinum-Resistant Ovarian Cancer Patients Announced January 11, 2026
FDA Clears IND for A2B543 for Mesothelin-expressing Solid Tumors lacking HLA-A*02 Expression January 11, 2026
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
