US FDA Approves INQOVI® in Combination with Venetoclax in AML Patients Ineligible for Intensive Induction Chemo May 21, 2026
First interim unblinding expected in June 2026 following 45 subject enrollment milestone achieved in MIRACLE trial May 21, 2026
45th subject enrolled in pivotal Ph 2B/3 MIRACLE trial of Annamycin + cytarabine (AnnAraC) for R/R AML March 24, 2026
Mipletamig Delivers Compelling 86% Clinical Benefit Rate and No CRS as Evaluable AML Patient Data increases by Nearly 50% March 17, 2026
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
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
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
Final 5-year Data on REZLIDHIA® (olutasidenib) in Patients with R/R mIDH1 AML published in the Journal of Hematology & Oncology November 24, 2025
