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FDA Grants Fast Track Designation to LYT-200 in R/R High-Risk MDS
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Fusion42 · 21 September 2026 · Fusion42 review
The FDA granted fast track designation to LYT-200, an anti–galectin-9 monoclonal antibody, combined with a hypomethylating agent for treating relapsed/refractory high-risk myelodysplastic syndromes, following promising phase 1b trial results.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 21 Sep 2026 and 22 Sep 2026.
◆ ◆ The Wire takeaway
You have a faster route to US regulatory review if you develop treatments for high-risk myelodysplastic syndromes with limited options. Winning this fast track means more trial data and FDA engagement will shape standard care soon.
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2 sources · first reported 21 Sep 2026 · latest 22 Sep 2026
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