PTC Therapeutics: FDA Extends Risdiplam Review After Additional Data Submitted
April 07 2020 - 5:29PM
Dow Jones News
By Stephen Nakrosis
PTC Therapeurtics, Inc. said Tuesday the U.S. Food and Drug
Administration has extended its review of risdiplam, an
investigational survival motor neuron splicing modifier for spinal
muscular atrophy, following the submission of additional data.
PTC is working with Roche and the SMA Foundation on the SMA
program.
PTC said additional data was submitted by Roche, which triggered
the extension. The FDA told Roche its team is working to complete
their review as quickly as possible, PTC said, adding "The FDA has
also indicated to Roche that no substantive review issues have been
identified to date."
PTC also said its European Medicine Agency submission remains on
track for the middle of this year.
Roche has also submitted applications for approval in Indonesia,
Taiwan, Chile, Brazil, South Korea and Russia, and a submission of
the filing in China is imminent, PTC said.
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 07, 2020 17:14 ET (21:14 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Sep 2023 to Sep 2024