Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease [Yahoo! Finance]
Supernus Pharmaceuticals, Inc. (SUPN)
Last supernus pharmaceuticals, inc. earnings: 2/25 04:40 pm
Check Earnings Report
US:NASDAQ Investor Relations:
ir.supernus.com
Company Research
Source: Yahoo! Finance
under FDA review for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson's disease (PD) The FDA has issued a Complete Response Letter (CRL) in response to the company's New Drug Application (NDA) for SPN-830. The CRL indicates that the review cycle for the application is complete but that the application still needs to be prepared for approval in its present form. The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. The first area relates to product quality. The company recently submitted additional product quality data to the FDA, which it has not yet reviewed. The second relates to the master file for the infusion device, which is proprietary to the device manufacturer. The company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830. No clinical safety or efficacy issues wer
Show less
Read more
Impact Snapshot
Event Time:
SUPN
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
SUPN 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
SUPN alerts
High impacting Supernus Pharmaceuticals, Inc. news events
Weekly update
A roundup of the hottest topics
SUPN
News
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPNPR Newswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPNAccesswire
- Supernus Pharmaceuticals to Announce First Quarter 2024 Financial Results and Host Conference Call on May 8, 2024GlobeNewswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPNGlobeNewswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPNPR Newswire
SUPN
Earnings
- 2/27/24 - Miss
SUPN
Sec Filings
- 4/24/24 - Form 8-K
- 4/24/24 - Form 8-K
- 4/8/24 - Form 8-K
- SUPN's page on the SEC website