October 29, 2026 edition, released October 30. The audio reflects the October 29 roundup; the INO-3107 watch refers to an October 30 FDA target date, not an announced decision.Iovance's lifileucel produced responses in 17 of 69 previously treated non-squamous lung cancer patients who received at least 10 billion viable cells. A new cohort, POSITILITY, will select patients up front using a subgroup profile found in a retrospective analysis. Ono's ONO-1110 missed primary endpoints in three Phase 2 pain studies; Ono is planning further pain studies based on prespecified subgroup and post hoc signals, and plans no further studies in depression or social anxiety. The daily roundup covers BMS ending Prothena's PRX019 license, Rafael's remibetadex NDA in Niemann-Pick type C after a Phase 3 primary-endpoint miss, a BioMarin Fabry license, Alnylam's TRITON-CM expansion, Lilly and Merck third quarters, and a Labor Department PBM disclosure rule.
The daily Closeout in under 15 minutes — trial readouts, FDA decisions, and the deal math behind them. Free.
Subscribe →