Krystal Biotech Shares More Than Double After Dystrophic EB Trial Meets Objectives
November 29 2021 - 8:11AM
Dow Jones News
By Michael Dabaie
Krystal Biotech Inc. shares more than doubled in premarket
trading after the company said a trial of Vyjuvek for dystrophic
epidermolysis bullosa met its primary and secondary objectives.
Dystrophic EB is a rare and severe disease that affects the skin
and mucosal tissues. The pivotal GEM-3 trial met its primary
endpoint of complete wound healing at six-month timepoints, and its
secondary endpoint of complete wound healing at three-month
timepoints, the company said.
Shares more than doubled, up 123% to $88.96 in premarket trading
Monday.
Vyjuvek was well tolerated, with no drug-related serious adverse
events or discontinuations, Krystal said.
The company said the biologics license application is on track
to be submitted to U.S. Food and Drug Administration in the first
half of 2022.
Krystal said it expects to submit a marketing authorization
application in Europe shortly after the BLA.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
November 29, 2021 07:56 ET (12:56 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Krystal Biotech (NASDAQ:KRYS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Krystal Biotech (NASDAQ:KRYS)
Historical Stock Chart
From Apr 2023 to Apr 2024