Orphazyme Shrinks Workforce Following FDA Response on Arimoclomol
28 June 2021 - 8:57PM
Dow Jones News
By Matt Grossman
Orphazyme AS is reducing its workforce by about two-thirds
following a recent U.S. regulatory finding that more data was
needed before its principal drug could be approved.
The Copenhagen-based company said the cost savings would help it
continue to pursue regulatory approval in Europe for arimoclomol as
a treatment for Niemann-Pick disease type C. The company will also
assess a path forward in the U.S.
The layoffs would reduce the company's operations to people
supporting essential activities.
Earlier in June, the U.S. Food and Drug Administration said it
needed more information beyond the single Phase 2/3 clinical trial
that Orphazyme had conducted. Chief Executive Christophe Bourdon
said at the time that he was disheartened by the outcome.
Neimann-Pick disease is a rare and debilitating neurovisceral
disease affecting about 1,800 people in the U.S. and Europe,
Orphazyme said.
Orphazyme's American depositary receipts traded on Nasdaq were
down 1% at $7.77 in premarket trade Monday and have lost 27% for
the year to date.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
June 28, 2021 06:51 ET (10:51 GMT)
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