SELLAS Life Sciences (SLS) provided a business update. “We believe that 2025 will be a pivotal year for SELLAS as we continue to advance our clinical stage portfolio of novel therapeutics for hematologic malignancies,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We aim to build on the excellent progress achieved in 2024 and look forward to several, potentially transformative clinical milestones. Specifically, we anticipate full topline dataset from our Phase 2 trial of SLS009 in acute myeloid leukemia patients resistant to venetoclax combination therapies and FDA regulatory feedback around our SLS009 study, as well as the interim analysis from Phase 3 REGAL being conducted by the Independent Data Monitoring Committee (IDMC). Based on the results of this analysis, the IDMC will provide their recommendation in January to either stop the trial early for efficacy, stop for futility, or continue the study without modification. If the recommendation is to continue, the next and final analysis will take place upon reaching a total of 80 events, as predefined in the study protocol.”
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