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
Enrollment of 20th Patient for Formal Interim Analysis in Phase 2 NGC-Cap Breast Cancer Study Completed January 11, 2026
Fourth consecutive case of response from Ph 1 data for the combination of AB8939 with venetoclax in R/R AML reported January 11, 2026
