IND application submitted to FDA for ALA-101 allogeneic CAR-iNKT cell therapy targeting CD19-positive NHL and leukemias January 4, 2026
FDA grants Fast Track Designation for SGR-1505 for the Treatment of R/R Waldenström Macroglobulinemia July 1, 2025
Positive Ph 2 interim results in R/R indolent NHL after EO2463 OncoMimics immunotherapy treatment presented June 24, 2025
FDA Breakthrough Therapy Designation granted to Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM) June 10, 2025
Updated Ph 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the treatment of NHL Announced May 21, 2025
First Patient enrolled in Ph 2 Trial of Ethanol-Free Carmustine in High-Dose Chemotherapy Prior to Transplant in Patients with HL or NHL April 22, 2025
U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia March 18, 2025
First Dose Cohort in STARLIGHT-1 Trial Completed and Approval Received to Initiate Higher Dose Cohort March 4, 2025
HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage CTCL January 21, 2025
U.S. FDA Fast Track Designation for NX-5948 for the Treatment of R/R Waldenstrom’s Macroglobulinemia December 25, 2024
First patient enrolled in triple combination arm of BI-1206, rituximab and Calquence® for the treatment of NHL September 18, 2024
AvantGen Receives Milestone Payment for First Patient Dosed in Ph 1 Study with Kite’s CAR-T Therapy March 12, 2024