Genentech Gets FDA Priority Review for Risdiplam for Spinal Muscular Atrophy

Date : 11/25/2019 @ 12:36PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 42.45  0.03 (0.07%) @ 8:59PM
After Hours
Last Trade
Last $ 42.45 ◊ 0.00 (0.00%)

Genentech Gets FDA Priority Review for Risdiplam for Spinal Muscular Atrophy

Roche Holding (QX) (USOTC:RHHBY)
Historical Stock Chart

2 Months : From Nov 2019 to Jan 2020

Click Here for more Roche Holding (QX) Charts.

By Colin Kellaher


Roche Holding AG's (ROG.EB) Genentech unit on Monday said the U.S. Food and Drug Administration accepted for priority review the company's new drug application for risdiplam for spinal muscular atrophy, or SMA.

Genentech said risdiplam, if approved, would be the first at-home administered medicine for people living with spinal SMA, an inherited, progressive neuromuscular disease.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

Genentech said the agency set a target action date of May 24, 2020.

PTC Therapeutics Inc. (PTCT), which initiated an SMA in partnership with the SMA Foundation in 2006, said the FDA'a acceptance of the filing triggers a $15 million milestone payment to the company from Roche under a 2011 licensing deal.

Genentech would commercialize risdiplam in the U.S. upon FDA approval.


Write to Colin Kellaher at


(END) Dow Jones Newswires

November 25, 2019 07:21 ET (12:21 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

Latest RHHBY Messages

{{bbMessage.M_Alias}} {{bbMessage.MSG_Date}} {{bbMessage.HowLongAgo}} {{bbMessage.MSG_ID}} {{bbMessage.MSG_Subject}}

Loading Messages....

No posts yet, be the first! No {{symbol}} Message Board. Create One! See More Posts on {{symbol}} Message Board See More Message Board Posts

Your Recent History
Gulf Keyst..
FTSE 100
UK Sterlin..
Stocks you've viewed will appear in this box, letting you easily return to quotes you've seen previously.

Register now to create your own custom streaming stock watchlist.

NYSE, AMEX, and ASX quotes are delayed by at least 20 minutes.
All other quotes are delayed by at least 15 minutes unless otherwise stated.