GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced the U.S. Food and Drug Administration (FDA) cleared the addition of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for relapsed/refractory (R/R) Acute Myeloid Leukemia (AML). The amendment will allow a time-based analysis of the primary endpoint of overall survival to be conducted following a defined cutoff date if the 295 survival events originally planned for an event driven analysis have not been observed. With the addition of a time-based analysis, topline results are expected to be reported by the end Q2 2024.
GlycoMimetics Announces U.S. Food and Drug Administration Clears Addition of Time-based Final Analysis to Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia
Jun 15, 2023
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