PureTech wins FDA Fast Track status for LYT-200 in relapsed or refractory high-risk MDS - PRTC News | RalliesPureTech wins FDA Fast Track status for LYT-200 in relapsed or refractory high-risk MDS
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PRTC• FDA Fast Track and Phase 2 plans for LYT-200
- PureTech won FDA Fast Track designation for LYT-200 with a hypomethylating agent in relapsed/refractory high-risk myelodysplastic syndromes.
- FDA End-of-Phase 1 meeting backed moving LYT-200 into the Phase 2 STRIDE-MDS trial, a randomized, double-blind, placebo-controlled study.
- Phase 2 plans call for about 125 patients, testing two LYT-200 doses to support dose selection.
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