Minerva Neurosciences Announces FDA Recommendation for Type C Meeting to Discuss Evidence for Use of Roluperidone as Monotherapy for the Treatment of Negative Symptoms in Patients with Sch...
Minerva Neurosciences, Inc (NERV)
Last minerva neurosciences, inc earnings: 3/9 07:30 am
Check Earnings Report
US:NASDAQ Investor Relations:
ir.minervaneurosciences.com/investor-relations
Company Research
Source: GlobeNewswire
WALTHAM, Mass., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the U. S. Food and Drug Administration (FDA) has denied the company’s request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy. Subject to the timing of and feedback from the FDA at a Type C guidance meeting, which the Company plans to request, the Company has not changed its previously announced projected timeline for submission of the NDA in the first half of 2022. Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva commented, “We thank the FDA for suggesting a Type C meeting to discuss roluperidone as a monotherapy for the treatment of negative symptoms in patients with schizophrenia. The
Show less
Read more
Impact Snapshot
Event Time:
NERV
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
NERV 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
NERV alerts
High impacting Minerva Neurosciences, Inc news events
Weekly update
A roundup of the hottest topics
NERV
News
- Minerva Neurosciences, Inc. (NASDAQ: NERV) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Business Updates [Yahoo! Finance]Yahoo! Finance
- Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Business UpdatesGlobeNewswire
- Minerva Neurosciences, Inc. (NASDAQ: NERV) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Minerva Neurosciences, Inc. (NASDAQ: NERV) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
NERV
Earnings
- 11/7/23 - Miss
NERV
Sec Filings
- 4/12/24 - Form 8-K
- 2/26/24 - Form 10-K/A
- 2/22/24 - Form 10-K
- NERV's page on the SEC website