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BioCentury
ARTICLE | Regulation

Protagonist’s Patel says rusfertide on track even as FDA move rattles investors

Agency reassessing breakthrough designation for polycythemia vera after adverse events

April 15, 2022 1:39 AM UTC

Although the specter of losing breakthrough designation for its lead therapy has rattled Protagonist investors, President and CEO Dinesh Patel told BioCentury that clinical timelines for rusfertide will not change regardless of what FDA decides.

Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 22% to $19.95 Thursday, equivalent to a loss of $269.7 million in market cap, after the company revealed in an SEC filing Wednesday that the agency intends to remove the designation for the injectable hepcidin mimeticin to treat polycythemia vera. ...

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