FDA Intends To Revoke Protagonist Therapeutics' Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer

Protagonist Therapeutics Inc PTGX received a letter from the FDA indicating the agency's intent to rescind Breakthrough Therapy Designation for the company's rusfertide product candidate in polycythemia vera. 

  • Polycythemia vera is a type of blood cancer. It causes bone marrow to make too many red blood cells. These excess cells thicken the blood, slowing its flow, which may cause serious problems, such as blood clots.
  • The company has submitted a meeting request to the FDA and a briefing document articulating why the company believes rusfertide continues to warrant Breakthrough Therapy Designation. 
  • Also Read: Protagonist Shares Almost Double As FDA Lifts Clinical Hold On Rusfertide Program.
  • The FDA letter does not relate to the rusfertide Fast Track Designation, which remains active. 
  • Initiation of the company's rusfertide Phase 3 study in polycythemia vera is underway, and no changes to the development plan or timeline are anticipated.
  • Price Action: PTGX shares are down 29.1% at $18.10 during the premarket session on the last check Thursday.

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