Onco-Summaries: Daily Oncology Updates at a Glance

21/09/2026

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• PureTech Secures FDA Alignment and Fast Track Designation for LYT-200 in Relapsed/Refractory High-Risk MDS

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PureTech Secures FDA Alignment and Fast Track Designation for LYT-200 in Relapsed/Refractory High-Risk MDS (Ref)

PureTech announced a positive regulatory milestone for its investigational therapy, LYT-200 (anti-Gal-9), including successful FDA alignment on its development path and receipt of Fast Track Designation in relapsed/refractory high-risk myelodysplastic syndromes (HR-MDS)

• PureTech Health reported a successful End-of-Phase 1 meeting with the FDA, supporting advancement of LYT-200 into the Phase 2 STRIDE-MDS trial for patients with relapsed/refractory HR-MDS

• The FDA granted Fast Track Designation to LYT-200 for this indication, providing an expedited pathway for development and regulatory interactions

  
  

The company plans to pursue external financing to support continued clinical development through its founded entity, Gallop Oncology

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