21st Sep 2026 10:34
(Alliance News) - PureTech Health PLC on Monday said feedback from the US Food & Drug Administration supports the advancement of its blood cancer treatment, LYT-200.
The Boston, Massachusetts-based biotech and pharmaceutical company said it has completed an end-of-phase one meeting with the US regulator and received FDA fast track designation for LYT-200 in combination with a hypomethylating agent for the treatment of relapsed/refractory high-risk myelodysplastic syndromes.
Fast track designation is a process designed to facilitate the development and expedite the review of drugs that target serious conditions with unmet medical need. Drugs receiving the designation may benefit from more frequent interactions with the US FDA throughout development, PureTech explained.
LYT-200 targets galectin-9, an oncogenic driver and potent immunosuppressor, and is being advanced by PureTech founded, Gallop Oncology.
PureTech intends to leverage external capital to support the continued development of LYT-200 through the completion of the phase 2 trial and expects to secure capital in the first half of 2027.
"Our productive End-of-Phase 1 meeting with the US FDA provides a clear path to advance LYT-200 into Phase 2 development," said Eric Elenko, acting chief executive officer of Gallop Oncology and co-founder of PureTech.
The end-of-phase one meeting was supported by positive top-line data from the completed phase 1b trial evaluating LYT-200 in combination with an HMA in heavily pretreated patients with R/R HR-MDS.
In that trial, LYT-200 demonstrated "compelling" clinical efficacy and a consistent safety profile in patients with R/R HR-MDS, all of whom had relapsed or become refractory to prior treatment with an HMA. PureTech said.
Shares in PureTech were down 0.8% at 121.60 pence each in London on Monday.
By Jeremy Cutler, Alliance News reporter
Comments and questions to [email protected]
Copyright 2026 Alliance News Ltd. All Rights Reserved.
Related Shares:
PureTech