Current Report · Items 8.01, 9.01 · 8-K
NRX Pharmaceuticals, Inc.
NRXPNASDAQEQUITYCurrent
Other Events
Item 8.01. Other Events. On September 15, 2026, NRx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as a Major Amendment, has been reclassified…
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Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events.
On September 15, 2026, NRx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as a Major Amendment, has been reclassified as a Minor Amendment.
The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.
A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.