Planned Unblinded Data Readout for MIRACLE Ph 3 R/R AML Pivotal Trial Accelerated to H2 2025 November 19, 2024
Annamycin + Ara-C achieved 60% CR/CRi in AML patients who were relapsed from or refractory to Venetoclax regimens November 19, 2024
Institutional Review Board Approves MIRACLE Ph 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R AML November 19, 2024
FDA Approves Revuforj® (revumenib) for Adult and Pediatric Patients with R/R Acute Leukemia with a KMT2A Translocation November 19, 2024
FAILED TRIAL: Ph 2/3 Study of Uproleselan Did Not Meet Primary Endpoint of EFS improvement in elderly 1L AML patients November 5, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric AML October 22, 2024
Galecto Completes Strategic Review to Focus on Oncology and Liver Disease and Acquires AML Preclinical Asset from Bridge Medicines October 8, 2024
FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in 1L AML for Patients Unfit for Induction Chemotherapy Treatment September 24, 2024
First patient dosed in Investigator-initiated Ph Ib study of iadademstat in 1L AML September 18, 2024
GBM program of INB-200 and INB-400 to be suspended; AML program of INB-100 to be prioritized September 10, 2024
New clinical data from ongoing Ph 1/2 VBP101 study of patients with R/R AML receiving trem-cel followed by Mylotarg announced September 10, 2024
FDA Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in R/R AML September 10, 2024
Nadunolimab clinical trials in AML/MDA and TNBC to be initiated in Q4 2024 and H2 2025, respectively September 3, 2024
Enrollment discontinued in SELECT-AML-1 Ph 2 trial of tamibarotene + venetoclax & azacitidine in newly diagnosed, unfit AML patients with RARA gene overexpression August 22, 2024
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
