regulatory
confidence high
sentiment negative
materiality 0.85
Salarius Pharmaceuticals announces FDA partial clinical hold on seclidemstat trial after grade 4 adverse event
Decoy Therapeutics Inc.
- A patient in MDACC's trial of seclidemstat + azacitidine for MDS/CMML experienced a serious unexpected grade 4 adverse event.
- FDA placed partial clinical hold; no new patients may enroll, but current subjects benefiting may continue treatment.
- Salarius will support MDACC in analyzing data and responding to FDA questions.