NRx Pharmaceuticals Reports Positive FDA Office of Generic Drugs Feedback on Preservative-Free Ketamine Program
NRX Pharmaceuticals, Inc. (NRXP)
Company Research
Source: GlobeNewswire
NRx has received a positive review letter (Discipline Review Letter) addressing Drug Quality requesting only “Minor” administrative changesNRx conducted a meeting with leadership of the FDA Office of Generic Drugs in which support was voiced for the potential approval of the Abbreviated New Drug Application within the current review cycle.Ketamine is identified as medically necessary by the US Department of Veterans Affairs for the treatment of suicidality and treatment-resistant depression.In addition to the current ANDA, NRx is in the process of submitting a New Drug Application to align the labeling of ketamine with its use in treating depression and suicidalityThe President’s April 16, 2026 Executive Order directs rapid approval for drugs that may be used to treat severe depression, suicidality, and PTSD WILMINGTON, Del., April 22, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a biopharmaceutical company that focuses on neuroplastic therapies for depression
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NRXP
News
- NRx Pharmaceuticals (NRXP) had its price target raised by Ascendiant Capital Markets from $48.00 to $49.00. They now have a "buy" rating on the stock.MarketBeat
- NRx Pharmaceuticals (NRXP) had its "buy" rating reaffirmed by HC Wainwright. They now have a $45.00 price target on the stock.MarketBeat
- New to The Street Broadcasts Show #746 Tonight on Bloomberg Television 6:30PM EST Featuring NRx Pharma (NASDAQ:NRXP), Performance Golf, Lost Soldier Oil & Gas, Dr. Lee Gause, and CISO Global [Yahoo! Finance]Yahoo! Finance
- New to The Street Broadcasts Show #746 Tonight on Bloomberg Television 6:30PM EST Featuring NRx Pharma (NASDAQ:NRXP), Performance Golf, Lost Soldier Oil & Gas, Dr. Lee Gause, and CISO GlobalACCESS Newswire
- NRx Pharmaceuticals (NRXP) had its "buy" rating reaffirmed by D. Boral Capital. They now have a $34.00 price target on the stock.MarketBeat
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