FDA Approves Lilly’s Once-Weekly Insulin Onswik, Challenging Novo’s Awiqli
FDA clears Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes. It may cut 300+ shots a year and now competes with Novo’s Awiqli.
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#XY Event-Driven Stocks↓
Acadia’s Alzheimer’s Psychosis Drug Missed Its Main Goal. Phase 3 Continues Anyway.
Acadia’s remlifanserin narrowly missed its Phase 2 primary endpoint in Alzheimer’s psychosis. Safety remained favorable, Phase 3 is continuing, and the stock sold off first.
Mesoblast Gets FDA Nod for Extra Quality Check on Ryoncil
Mesoblast received FDA approval for a new TIBA assay to check strength and stability of every commercial Ryoncil batch as manufacturing scales.
FDA Signs Off on aTyr’s Revised Phase 3 Plan in Pulmonary Sarcoidosis
After EFZO-FIT missed, aTyr has FDA alignment on a narrower Phase 3 using FVC. Cash funds operations into 2028, but not the new trial.
Galleri Cancer Blood Test Wins Mixed but Favorable FDA Panel Vote
FDA panel endorsed GRAIL’s Galleri as an add-on cancer blood test. Approval is not final. Coverage, labeling, and whether it saves lives remain open.
New Arcturus Data Supports Liver mRNA Platform as Company Advances Faster Path for Improved OTC
Arcturus shares positive OTC deficiency Phase 2 findings, plans to add ARCT-2601 by year-end 2026, and acquires AI firm myNEO.