NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression

• This designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year and represents a 10x expansion of the addressable population compared to the Designation granted in 2017 for bipolar depression alone
• The Designation includes an FDA determination that NRX-100 has the potential to address an unmet need, based on FDA's assessment of the data submitted
• Determination of "unmet need" is a requirement for a Commissioner's National Priority Voucher (CNPV) program.
• Suicide is a public health crisis. Approximately 13 million adults seriously consider suicide each year, according to the CDC, 3.7 million make a plan to commit suicide. An American dies from suicide every 11 minutes. Active-duty personnel, veterans, and first responders have a four-fold higher risk of suicide.

WILMINGTON, Del., Aug. 11, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a clinical-stage biopharmaceutical company, today announced US Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. This designation for NRX-100 as a standalone drug is a 10-fold expansion of the addressable population for NRX-100, compared to the designation granted in 2017 for NRX-100 in combination with NRX-101 (DCS/lurasidone) for treatment of Suicidal Bipolar Depression.

In granting the Fast Track designation, FDA made the determination that NRX-100 has the potential to address an unmet medical need, based on an assessment of the preliminary data contained in the Fast Track designation request. This determination of unmet medical need aligns with the eligibility requirements for the Commissioner's National Priority Voucher Program (CNPV)i and for the FDA's Accelerated Approval Program.ii The Company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100.

Several well-controlled trials submitted to FDA in support of Fast Track Designation demonstrated a clinically meaningful and statistically significant reduction of suicidal ideation. In a Columbia University study licensed by NRx, suicidal patients treated with intravenous ketamine demonstrated a 55% response (i.e. 50% reduction in suicidality) compared to a 30% response to active comparator (P$3 billion Suicidal Depression market in the US.

References

i https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-programii https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accelerated-approval-expedited-program-serious-conditionsiii Grunebaum, et al. Ketamine for rapid reduction of suicidal thoughts… Am J Psychiatry 2018;175:327-335.iv Abbar, et al. Ketamine for the acute treatment of severe suicidal ideation… BMJ 2021;167:194-203

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.

NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. The filing is based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France, licensed under a data sharing agreement.

Notice Regarding Forward-Looking StatementsThe information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

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