PureTech Health's Gallop Oncology cleared its End-of-Phase 1 meeting with the FDA and secured Fast Track designation for LYT-200, paving the way for a Phase 2 trial in relapsed or refractory high-risk myelodysplastic syndromes.

Celea Therapeutics has launched as an independent company following a $180 million financing, retaining a 35.4% stake plus royalties as the parent shifts to a leaner operating model.

"We believe these results substantially derisk our future clinical development approach and strengthen the differentiated profile of GlyphAgo," said Daphne Zohar, Co‑Founder and Chief Executive Officer of Seaport Therapeutics.

The drug developer has reported positive top-line Phase 1b results for LYT-200, selected a 12 mg/kg recommended Phase 2 dose and said its Founded Entity Gallop Oncology will prioritise relapsed/refractory high‑risk MDS and engage the FDA on a potentially registrational trial.