AMGN · 8-K · 20260804PR000124
FDA Clinical Holds
AMGEN INC · 2026-08-04 · Importance 44 · Surprise 60 · In source text
The FDA placed a partial clinical hold on two potentially registration-enabling subcutaneous blinatumomab studies in adults, adolescents, and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Enrollment of new patients has paused in both studies. Amgen is discussing a path with the FDA to reopen the studies.
Key facts
- A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab in adults and adolescents with relapsed or refractory CD19-positive Ph-negative B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA; a pediatric Phase 1b/2 study has likewise paused enrollment and discussions are underway with the FDA to reopen both studies. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | negative | contingent | — | A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab in adults and adolescents with relapsed or refractory… |