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SELLAS has a pivotal Phase 3 trial (REGAL) of galinpepimut-S (GPS) in acute myeloid leukemia (AML) with a positive IDMC recommendation to continue; final analysis expected by year-end 2025. SLS009, a highly selective CDK9 inhibitor, showed positive Phase 2 results in relapsed/refractory AML and is about to enter first-line clinical trials. Both programs are in late-stage development with expansion into additional hematologic and solid tumor indications.[1][7]
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