Quince Therapeutics to Advance Study of EryDex as FDA Lifts Application Hold
September 28 2023 - 3:53PM
Dow Jones News
By Denny Jacob
Quince Therapeutics said it intends to advance trials on EryDex
following the U.S. Food and Drug Administration's hold being lifted
on EryDel's investigational new drug application.
The biotechnology company said it intends to advance a clinical
trial to evaluate the safety and efficacy of EryDex for the
potential treatment of Ataxia-Telangiectasia, a rare and fatal
pediatric neurological disease, pending the close of its
acquisition of EryDel. The FDA had imposed a partial clinical hold
on the application for EryDex.
"This pivotal trial will be conducted under a Special Protocol
Assessment that has already been reviewed with the FDA," said
Quince Chief Executive Dirk Thye, "which should allow for the
submission of a new drug application following completion of this
single study, assuming positive results."
Quince said its acquisition is expected to close in the fourth
quarter.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
September 28, 2023 16:38 ET (20:38 GMT)
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