PureTech Health plc announced that its end‑of‑phase II meeting with the U.S. Food and Drug Administration (FDA) for the idiopathic pulmonary fibrosis (IPF) candidate deupirfenidone (LYT‑100) was successful, giving the company a clear go‑ahead to launch a pivotal Phase III study. The FDA’s feedback confirmed that the streamlined 505(b)(2) regulatory pathway is appropriate, removing a major uncertainty that had previously weighed on the program’s timeline and cost profile.
Continue reading for full analysis...
Gallop Oncology reported that its Phase 1b study of the anti‑galectin‑9 antibody LYT‑200 produced striking topline data in patients with relapsed or refractory acute myeloid leukemia (AML) and high‑risk myelodysplastic syndrome (MDS). The 101‑patient trial, which enrolled heavily pre‑treated individuals, showed a median overall survival of 13.2 months in the combination cohort receiving LYT‑200 with venetoclax and a hypomethylating agent—an improvement that far exceeds the typical <2.5‑month survival seen in this setting.
Continue reading for full analysis...