Sarepta Therapeutics Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investorrelations.sarepta.com/events-and-presentations
Company Research
Source: GlobeNewswire
CAMBRIDGE, Mass., Aug. 19, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. The CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides. Renal toxicity with golodirsen was observed in pre-clinical models at doses that were ten-fold higher than the dose used in clinical studies. Renal toxicity was not observed in Study 4053-101, on which the application for golodirsen was based. “We are very surprised to have
Show less
Read more
Impact Snapshot
Event Time:
SRPT
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
SRPT alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
SRPT alerts
High impacting Sarepta Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
SRPT
News
- Exploring 3 High Growth Tech Stocks in United States [Yahoo! Finance]Yahoo! Finance
- High Growth Tech Stocks To Watch For Potential Investment [Yahoo! Finance]Yahoo! Finance
- High Growth Tech Stocks To Explore In November 2024 [Yahoo! Finance]Yahoo! Finance
- High Growth Tech Stocks Featuring ALSO Holding And 2 More [Yahoo! Finance]Yahoo! Finance
- High Growth Tech Stocks To Watch In The Current Market [Yahoo! Finance]Yahoo! Finance
SRPT
Earnings
- 11/6/24 - Beat
SRPT
Sec Filings
- 11/14/24 - Form SC
- 11/13/24 - Form SC
- 11/6/24 - Form 10-Q
- SRPT's page on the SEC website