On April 13, 2022, after market hours, Protagonist Therapeutics disclosed in a filing with the U.S. Securities and Exchange Commission that “[t]he Company has received a letter from United States Food and Drug Administration (the “FDA”) indicating the FDA’s intent to rescind Breakthrough Therapy Designation for the Company’s rusfertide product candidate in polycythemia vera,” citing “observed malignancies[.]”
On this news, Protagonist’s stock price fell $5.57 per share, or 21%, to close at $19.95 per share on April 14, 2022.