Protagonist down 22% after FDA plans to rescind Breakthrough Therapy designation for rusfertide

Apr. 14, 2022 12:06 PM ETProtagonist Therapeutics, Inc. (PTGX)By: Jonathan Block, SA News Editor2 Comments

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  • Shares of Protagonist Therapeutics (NASDAQ:PTGX) have tumbled 22% on Thursday after the company disclosed in an securities filing after the closing bell Wednesday that the U.S. FDA intends to remove Breakthrough Therapy designation for rusfertide for polycythemia vera.
  • The agency indicated it was seeking to make the move based on observed malignancies in some patients in trials.
  • In an updated corporate presentation, Protagonist (PTGX) said that 168 patients had received rusfertide in all indications under development. Eight cancer cases were seen in seven participants, though this number includes pre-existing cases.
  • The company has submitted a meeting request to the FDA as well as a document arguing why Breakthrough Therapy status should be continued for rusfertide in polycythemia vera.
  • Separately, Protagonist (PTGX) said that it expects top-line data from a phase 2 clinical trial of PN-943 for ulcerative colitis in Q2.
  • Seeking Alpha's Quant Rating gives Protagonist (PTGX) a hold rating.

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