Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial July 30, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric AML July 23, 2024
Ph 1/2 dose-escalation study of SP-2577 in combination with azacitidine in adults with MDS and CMML Placed on Partial Hold July 17, 2024
HREC Approval and CTN Clearance granted from the TGA to Commence a Ph 1 Clinical Trial for INT2104 for B Cell Malignancies July 17, 2024
FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL July 1, 2024
FDA approved blinatumomab in the consolidation phase of multiphase chemo for adult & pediatric patients with CD19+ve Ph–neg B-cell precursor ALL June 18, 2024
European Commission granted Orphan Drug Designation to UCART22 for the treatment of ALL June 11, 2024
FAILED TRIAL: Uproleselan failed to demonstrate significant OS improvement for patients with primary refractory AML in pivotal Ph 3 trial June 11, 2024
FDA clears IND for Ph 1/2a trial (TCX-101) of BSB-1001 for patients with R/R AML, ALL and MDS, in conjunction with alloHSCT June 11, 2024
FDA grants RMAT designation to TSC-100 & TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning June 4, 2024
First Patient Dosed in Investigator-Initiated Trial (IIT) of Danvatirsen in Ph 1 for AML/MDS Cancers May 21, 2024
RAPHAEL Registrational Ph 3 Trial of HMPL-306 for Patients with IDH1- and/or IDH2-Mutated R/R AML in China Initiated May 21, 2024
First Patient Dosed in Ph 1 Trial of SENTI-202 for the Treatment of R/R Hematologic Malignancies Including AML May 21, 2024
Higher AML Complete Remission (CR) Rates and Significant Durability Reported with Additional Interim Subject Data May 15, 2024
FAILED TRIAL: Pivotal Ph 3 Study of Uproleselan in R/R AML patients did not meet primary endpoint of OS in the intent-to-treat population May 14, 2024
First Patients Dosed in Two Ph 1 Trials of REM-422 of Adenoid Cystic Carcinoma (ACC) and AML/MDS May 7, 2024
