Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the planned discussion with the FDA leading to the confirmation to file a New Drug Application (NDA) for relutrigine in early 2026. “We are very pleased with the collaborative discussions we've had with the FDA, which support our path toward an NDA submission in early 2026,” said Marcio Souza, president and chief executive officer. “Building on the unprecedented and compelling results from the EMBOLD study, where relutrigine demonstrated statistically significant and clinically meaningful improvements, we are advancing toward delivering a much-needed therapy for children living with these devastating diseases.” About Relutrigine (PRAX-562)Relu
Show less
Read more
Impact Snapshot
Event Time:
PRAX
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
PRAX 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
PRAX alerts
High impacting Praxis Precision Medicines, Inc. news events
Weekly update
A roundup of the hottest topics
PRAX
News
- Praxis Precision Medicines (NASDAQ:PRAX) was given a new $313.00 price target on by analysts at Deutsche Bank Aktiengesellschaft.MarketBeat
- Praxis Precision to file an NDA for relutrigine in encephalopathies in 2026 [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026 [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic EncephalopathyGlobeNewswire
- Praxis Precision Medicines (NASDAQ:PRAX) had its "buy" rating reaffirmed by analysts at Jefferies Financial Group Inc..MarketBeat
PRAX
Earnings
- 11/5/25 - Beat
PRAX
Sec Filings
- 12/11/25 - Form 8-K
- 12/8/25 - Form 8-K
- 11/21/25 - Form 4
- PRAX's page on the SEC website