Regulatory Discussions with FDA on Potential Resubmission Path for ANKTIVA® in BCG-Unresponsive Papillary Bladder Cancer Advanced January 25, 2026
Sofetabart mipitecan receives US FDA Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer January 25, 2026
FDA Grants Breakthrough Therapy Designation to WU-CART-007 for Treatment of R/R T-ALL/LBL January 25, 2026
Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of Myelofibrosis January 25, 2026
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
