Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required August 22, 2024
Pivotal, adaptive MIRACLE Ph 3 trial designed for possible accelerated approval of Annamycin + cytarabine for the treatment of R/R AML August 7, 2024
Regulatory path forward for uproleselan in R/R AML would require an additional clinical trial July 30, 2024
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
FAILED TRIAL: Uproleselan failed to demonstrate significant OS improvement for patients with primary refractory AML in pivotal Ph 3 trial 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
Positive Ph 2 Preliminary Data of SLS009 in R/R AML Achieving a 100% Response Rate in Patients with ASXL1 Mutation at the Optimal Dose Level Announced May 7, 2024
Positive Recommendation of IDMC Following Completion of Enrollment in REGAL Ph 3 Study Announced May 1, 2024
