PTC Announces Regulatory Update on Risdiplam for Spinal Muscular Atrophy (SMA)
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
SOUTH PLAINFIELD, N.J., April 7, 2020 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam to August 24, 2020. Roche recently submitted additional data including comprehensive data from SUNFISH part 2 to help provide access to risdiplam for a broad range of people living with spinal muscular atrophy (SMA), triggering this extension. The FDA has informed Roche that the review team is working expeditiously to complete their review of the application as quickly as possible. The FDA has also indicated to Roche that no substantive review issues have been identified to date. "We are encouraged that the FDA has no substantive review issues. Their interest in the additional results from the clinical studies demonstrating risdiplam's activity supports our goal of enabling access to this important therapy for
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
- Principal Spectrum Preferred Secs Active ETF declares monthly distribution of $0.0827 [Seeking Alpha]Seeking Alpha
- Principal Investment Grade Corporate Active ETF declares monthly distribution of $0.0792 [Seeking Alpha]Seeking Alpha
- PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
- PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
- PTC Therapeutics (NASDAQ:PTCT) was downgraded by analysts at Royal Bank Of Canada from an "outperform" rating to a "sector perform" rating.MarketBeat
PTCT
Earnings
- 11/4/25 - Beat
PTCT
Sec Filings
- 12/5/25 - Form 4
- 12/4/25 - Form SCHEDULE
- 12/3/25 - Form 4
- PTCT's page on the SEC website