FAILED TRIAL: Ph 3 Study of XOSPATA™ (gilteritinib) Did not Meet Primary Endpoint of OS in Patients with Newly Diagnosed FLT3m+ AML March 10, 2026
IND filed with FDA for Ph 2 study of TBS-2025 for the treatment of R/R mutNPM1 AML in combination with a menin inhibitor February 25, 2026
Calquence + venetoclax approved in the US as oral, fixed-duration combination for 1L CLL patients February 25, 2026
QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia February 1, 2026
FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma February 1, 2026
FDA Approves Larger Vial Size for Nelarabine IV Administration for the Treatment of T-ALL and T-LBL February 1, 2026
FDA Grants Breakthrough Therapy Designation to WU-CART-007 for Treatment of R/R T-ALL/LBL January 25, 2026
Clinical Update provided on Ph 1 Trial of CER-1236 in AML (CertainT-1) Highlighting Key Safety and Efficacy Data Observed in a Patient with MDS/AML 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
Update Provided on Pivotal Ph 3 REGAL Trial of Galinpepimut-S (GPS) in AML; no outcome analyses performed December 30, 2025
Global Registrational Ph 3 Study of Olverembatinib in 1L Ph+ ALL Cleared by FDA and EMA December 9, 2025
IND Clearance and EMA Approval of CTA for Ph 1/2 QUADvance Study of AVC-203 for R/R B-cell malignancies announced December 9, 2025
FDA approves expanded indication for Jaypirca (pirtobrutinib) for adults with R/R CLL/SLL previously treated with a covalent BTK inhibitor December 9, 2025
New Data Announced from Ph 1b/2 EPCORE® CLL-1 Trial of Epcoritamab as Monotherapy and in Combination for Patients with Richter Transformation (RT) December 9, 2025
