regulatory
confidence high
sentiment neutral
materiality 0.50
Protagonist transitions rusfertide NDA regulatory leadership to Takeda
Protagonist Therapeutics, Inc
- Takeda to lead regulatory strategy and NDA preparation for rusfertide in polycythemia vera; transition underway.
- Protagonist remains primarily responsible for clinical development activities through NDA filing.
- Decision made under License and Collaboration Agreement dated January 31, 2024, as amended.