{
  "id": 8863944,
  "title": "PureTech’s LYT-200 receives FDA fast track for blood cancer",
  "url": "https://urgent.news/2026/09/21/puretechs-lyt-200-receives-fda-fast-track-for-blood-cancer",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-21T06:46:16.000Z",
  "source": {
    "name": "Investing.com",
    "slug": "investing-com",
    "url": "https://www.investing.com/news/company-news/puretechs-lyt200-receives-fda-fast-track-for-blood-cancer-93CH-4908310"
  },
  "original_language": "en",
  "account": "London - PureTech Health plc's Gallop Oncology unit has secured Fast Track designation from the U.S. Food and Drug Administration for LYT-200, a fully human monoclonal antibody targeting galectin-9, in combination with a hypomethylating agent. This designation, intended for drugs addressing serious conditions with unmet medical need, enables more frequent FDA communications and expedites review processes.\n\nLYT-200 is set to undergo Phase 2 STRIDE-MDS trial, aiming to enroll around 125 patients with relapsed/refractory high-risk myelodysplastic syndromes. The randomized, double-blind, placebo-controlled study will assess the efficacy of LYT-200 at two different doses, either combined with a hypomethylating agent or a placebo plus the same agent. The trial will be divided into three groups, with a 2:2:1 ratio.\n\nA Phase 1b trial previously demonstrated promising results, with 27.3% complete response rate, 36.3% complete plus partial response, and 45.5% overall response rate in patients receiving LYT-200 at 12 mg/kg with a hypomethylating agent. No dose-limiting toxicities or myeloid suppression were reported.\n\nMyelodysplastic syndromes affect approximately 60,000-170,000 people in the United States, with 30-40% of cases being high-risk. Currently, only one FDA-approved therapy exists for relapsed/refractory high-risk myelodysplastic syndromes, targeting a genetic mutation found in about 3% of patients. PureTech aims to raise external capital in the first half of 2027 to support LYT-200 development through the Phase 2 trial completion.",
  "summary": null,
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}