Positive FDA Guidance Received for Acceleration of Registration-Enabling MIRACLE Trial for R/R AML February 19, 2025
Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Announced February 11, 2025
FAILED TRIAL: Ph 3 Bridging Trial in China in Patients with R/R AML did not demonstrate favorable benefit for uproleselan December 26, 2024
Reprioritized pipeline focus on LAVA-1266 and plan to discontinue development of LAVA-1207 December 18, 2024
Efficacy threshold not achieved in Ph 1 dose escalation trial for FHD-286 + decitabine to support continued development in patients with R/R AML December 18, 2024
TC BioPharm Partners with CareDx to Support ACHIEVE Clinical Trial Using AlloCell for PK Monitoring of Allogeneic Cell Therapy December 12, 2024
Aptose Signs CRADA with NCI to Develop Tuspetinib for AML and MDS in Newly Launched MyeloMATCH Precision Medicine Trials December 10, 2024
FDA Approves IMKELDI (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers December 4, 2024
Positive Initial Clinical Data Announced in Ph 1 Clinical Trial of SENTI-202 for the Treatment of R/R Hematologic Malignancies Including AML December 4, 2024
First Patient Dosed in Ongoing RAINIER Trial Achieves 90% Reduction in Leukemic Blasts Within the First 30 Days of Treatment, Continues Overall Efficacy Trend Seen in Prior Mipletamig AML Studies November 26, 2024
Kura Oncology and Kyowa Kirin Announce Global Strategic Collaboration to Develop and Commercialize Ziftomenib in Acute Leukemias November 26, 2024
TUSCANY Ph 1/2 Study for Newly Diagnosed AML Patients Initiated to Receive Tuspetinib-based Triplet Therapy November 26, 2024
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
NDA for Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA 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
