NRx Pharma Announces Grant Of Filing Fee Waiver By FDA To Exempt NRx From $4.3M Fee To File New Drug Application For NRX-100

• Waiver exempts NRx from paying a $4.3 million New Drug Application filing fee under the Prescription Drug User Fee Act (PDUFA)
• Company is on track for Q2 2025 completion of NDA filing and PDUFA date by year end with currently available corporate resources
• NRX-100, together with NRX-101, was granted Fast Track designation by FDA for treatment of suicidal bipolar depression in 2018
• Company notes recent statements by Secretary of Health and Human Services regarding the public health importance of approving psychedelic drugs such as ketamine to treat suicidal depression and PTSD

MIAMI, April 30, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc., (NASDAQ:NRXP, the Company", ))), today announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine). The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. The Company anticipates that this waiver enables the completion of its New Drug Application for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of the second quarter of this year (Q2 2025).