NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application
NRX Pharmaceuticals, Inc. (NRXP)
Company Research
Source: GlobeNewswire
Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA).FDA has advised NRx in written correspondence that it has not identified any bioequivalence deficiencies in the Company’s Preservative-Free Ketamine product. This communication is deemed preliminary until final supervisory review.NRx continues to anticipate an FDA GDUFA decision on its ANDA application in Summer 2026 as previously announced.The ANDA process is focused on offering a preservative-free alternative in the existing ketamine market through the FDA Office of Generic Drugs and is separate from NRx’s path to a New Drug Application to use ketamine in the treatment of depression, being pursued through the FDA Division of Psychiatry Products. WILMINGTON, Del., March 17, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has received a letter from the Bioequivalenc
Show less
Read more
Impact Snapshot
Event Time:
NRXP
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
NRXP 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
NRXP alerts
High impacting NRX Pharmaceuticals, Inc. news events
Weekly update
A roundup of the hottest topics
NRXP
News
- InvestorNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Files 2025 Form 10-K And Highlights Operational Progress [TheStreet.com]TheStreet.com
- NRX Pharmaceuticals Inc (NRXP) Q4 2025 Earnings Call Highlights: Strategic Advances and ... [Yahoo! Finance]Yahoo! Finance
- NRx Pharmaceuticals (NRXP) had its "buy" rating reaffirmed by D. Boral Capital. They now have a $34.00 price target on the stock.MarketBeat
- NRx Pharmaceuticals (NRXP) had its "buy" rating reaffirmed by BTIG Research. They now have a $25.00 price target on the stock.MarketBeat
- NRx Pharmaceuticals, Inc. (NRXP) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
NRXP
Earnings
- 11/14/25 - Miss
NRXP
Sec Filings
- 3/24/26 - Form 8-K
- 3/23/26 - Form 10-K
- 2/24/26 - Form DEFA14A
- NRXP's page on the SEC website