By Michael Dabaie

 

Protara Therapeutics Inc. said the U.S. Food and Drug Administration cleared its investigational new drug application for TARA-002 for the treatment of non-muscle invasive bladder cancer, sending shares higher in premarket trade.

Protara, a clinical-stage company focused on cancer and rare diseases, said it expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of this year.

Shares rose 24% to $8.37 early Tuesday.

The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a maximum tolerated dose and recommended dose for a future Phase 2 clinical study.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

October 12, 2021 07:41 ET (11:41 GMT)

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