acute myeloid leukemia

Recent reports from two drug companies that had been conducing separate clinical trials to evaluate cancer treatments reveal that the trials were halted due to the deaths of six participants, including one child.  One of the trials had focused on assessing a potential treatment...

The FDA has lifted the partial clinical hold on Gilead Sciences Inc's (NASDAQ: GILD) studies evaluating magrolimab combined with azacitidine.  The FDA removed the partial clinical hold after reviewing the comprehensive safety data from each trial. The company can...

Moleculin Biotech Inc (NASDAQ: MBRX) has announced preliminary results supporting the successful conclusion of its second Phase 1 trial in Poland, evaluating Annamycin for relapsed and refractory acute myeloid leukemia (AML). Moleculin determined a dose of 240 mg/m2 as the...

The FDA has lifted the partial clinical hold on Kura Oncology Inc (NASDAQ: KURA) KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML).  The partial clinical hold was lifted following an agreement with the agency on the...

IN8bio Inc (NASDAQ: INAB) has provided an update on the Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapy for leukemia patients undergoing haploidentical hematopoietic stem cell transplant (HSCT).  The three patients with relapsed acute myeloid...

Precigen Inc (NASDAQ: PGEN) presented positive interim data at the ASH Annual Meeting and Exposition from the ongoing Phase 1/1b study of PRGN-3006 UltraCAR-T in relapsed or refractory (r/r) acute myeloid leukemia and higher-risk myelodysplastic syndromes. PRGN-3006 UltraCAR-T is a...

Aptose Biosciences Inc (NASDAQ: APTO) presented data from the ongoing Phase 1/2 study of HM43239 in patients relapsed or refractory acute myeloid leukemia (AML) who had received at least one prior line of therapy. Data were presented at the American Society of Hematology (ASH)...

The FDA has slapped a partial clinical hold on the early-stage program for one of Kura Oncology Inc’s (NASDAQ: KURA) cancer drugs following a patient’s death in a clinical trial. Kura reported that the Phase 1b study of KO-539 for acute myeloid leukemia would be...

Aptevo Therapeutics Inc (NASDAQ: APVO) has announced a clinical update for its Phase 1b Expansion trial evaluating APVO436 for acute myeloid leukemia (AML).  A high-risk AML patient treated in Cohort 1 with a combination of chemotherapy plus APVO436 achieved a complete remission...

Rafael Holdings Inc's (NYSE: RFL) Rafael Pharmaceuticals Inc announced that the AVENGER 500 Phase 3 trial for CPI-613 (devimistat) did not meet its primary endpoint of significant improvement in overall survival in pancreatic cancer patients. Data from 528 patients...

AstraZeneca Plc (NASDAQ: AZN) has paused an active Phase 1 trial of AZD5991, a direct inhibitor of MCL-1, citing a potential safety issue. Two years ago, the FDA hit Amgen Inc (NASDAQ: AMGN) with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity....

Nkarta Inc (NASDAQ: NKTX) has updated guidance on initial data readout of Phase 1 trial of NKX101 in relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes. Data from the engineered CAR NK cell therapy candidate targeting the NKG2D ligand is expected...

GlycoMimetics Inc (NASDAQ: GLYC) has announced that efficacy and safety data from a Phase 1/2 study of uproleselan were published online in the journal BLOOD.  In the manuscript, scientists highlighted an analysis of minimal residual disease (MRD). The paper's lead author noted...

The FDA has signed off Intellia Therapeutics Inc's (NASDAQ: NTLA) investigational new drug (IND) application for NTLA-5001. Related Content: Intellia Shares Shoot Higher On Promising Biomarker Data From CRISPR/Cas9 Genome Editing Candidate. NTLA-5001 is an autologous T cell...

The FDA has signed off Magenta Therapeutics Inc's (NASDAQ: MGTA) IND application for MGTA-117. Related Content: Magenta Therapeutics Stock Drops As FDA Issues Clinical Hold On Blood Cancer Candidate IND. The Company expects to open the Phase 1/2 trial in Q4 2021 to evaluate...