By Matt Grossman

 

Protagonist Therapeutics Inc. said Monday that the U.S. Food and Drug Administration has lifted its clinical hold on rusfertide, allowing trials using the drug to resume.

The hold had been put in place after a finding that mice used in a study had developed benign and malignant skin tumors.

"No other unexpected safety signals surfaced" from the review that followed, Protagonist said.

A Phase 3 study for the drug's use in treating polycthemia vera, a type of blood cancer, could begin in next year's first quarter, Protagonist said.

 

Write to Matt Grossman at matt.grossman@wsj.com

 

(END) Dow Jones Newswires

October 11, 2021 07:37 ET (11:37 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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