FDA places clinical hold on Protagonist's rusfertide program after tumor finding in mouse study

Protagonist Therapeutics, Inc

FDA clinical hold on all rusfertide studies after rasH2 mouse model showed benign/malignant subcutaneous skin tumors.
Four cancer cases observed across rusfertide trials assessed as unrelated; company providing additional safety data to FDA.
Dosing paused in all ongoing trials; investigators contacted to notify patients.
Rusfertide is a Phase 2 hepcidin mimetic for polycythemia vera and hereditary hemochromatosis.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.