CHMP Maintains Negative Opinion on Translarna™ Reexamination
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
Check Earnings Report
US:NASDAQ Investor Relations:
ir.ptcbio.com
Company Research
Source: PR Newswire
- Opinion to be reviewed by European Commission -WARREN, N.J., Oct. 18, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne Muscular Dystrophy (nmDMD) following re-examination. The opinion will now be reviewed by the European Commission (EC) which is expected to decide on opinion adoption in approximately 67 days."CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna. That evidence includes data across three placebo-controlled trials and our STRIDE registry that demonstrates consistent short and long-term efficacy as well as safety supportive of continued authorization. In addition, the CHMP opinion is clearly a
Show less
Read more
Impact Snapshot
Event Time:
PTCT
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
PTCT 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
PTCT alerts
High impacting PTC Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
PTCT
News
- PTC Therapeutics Announces FDA Acceptance of Translarna™ NDA ResubmissionPR Newswire
- PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
- PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2024 Financial ResultsPR Newswire
- PTC Therapeutics Announces FDA Target Regulatory Action Date for Sepiapterin and Lancet Publication of Phase 3 Trial ResultsPR Newswire
- PTC Therapeutics, Inc. (NASDAQ: PTCT) had its price target raised by analysts at Morgan Stanley from $32.00 to $45.00. They now have an "equal weight" rating on the stock.MarketBeat
PTCT
Earnings
- 8/8/24 - Beat
PTCT
Sec Filings
- 10/18/24 - Form SC
- 10/18/24 - Form 8-K
- 8/8/24 - Form 10-Q
- PTCT's page on the SEC website