Press Releases August 7, 2026 04:01 PM

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Host Conference Call August 10 to Discuss FDA First-Cycle ANDA Review and Commercial Plans

NRx Pharmaceuticals to Discuss FDA Review of ANDA for Preservative-Free Ketamine and Commercial Strategy in August 10 Conference Call

By Jordan Park
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NRx Pharmaceuticals announced a conference call on August 10 to discuss the FDA's first-cycle review completion of its Abbreviated New Drug Application (ANDA) for preservative-free ketamine (NRX-100). The company will cover regulatory progress and commercial plans for this clinical-stage biopharmaceutical product targeting central nervous system disorders such as suicidal depression and bipolar depression. NRX-100 has Fast Track Designation and the company has filed applications indicating progress toward potential market approval.

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Host Conference Call August 10 to Discuss FDA First-Cycle ANDA Review and Commercial Plans
NRXP
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Key Points

  • NRx Pharmaceuticals completed FDA first-cycle review of ANDA for NRX-100, a preservative-free intravenous ketamine product targeting suicidal ideation in depression and bipolar depression.
  • The company plans a conference call to discuss regulatory pathway and commercial strategies involving senior leadership, including experienced pharmaceutical executives.
  • NRX-100 has Fast Track Designation, and the company is seeking priority review via the Commissioner’s National Priority Voucher Program, highlighting its significance in psychiatric therapeutics.

MIAMI, Aug. 07, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a conference call and Q&A session on Monday, August 10, 2026 at 8:30 a.m. Eastern Time to discuss the FDA's completion of first-cycle review of the Company's ANDA for preservative-free ketamine, announced earlier today.

Participating on the call will be Jonathan Javitt, MD, MPH, Founder and Chief Executive Officer; Glenn Tyson, Chief Commercial Officer; and Chaim Hurvitz, Director, former director of Teva and President of the Teva International Group. Questions will cover both the regulatory path to approval and the Company's commercial plans.

A live webcast of the conference call will be available on the Company’s website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-864-5102 or internationally 1-646-394-9810. A replay of the webcast will be available on the Company’s website following the event.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), 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 filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

Notice Regarding Forward-Looking Statements

The 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.

For further information:

Brian Korb
Managing Partner, astr partners
(917) 653-5122
[email protected]


Risks

  • The FDA approval process remains uncertain as only the first cycle review is completed; subsequent regulatory hurdles may delay or prevent market entry.
  • The company's financial performance depends on successful regulatory approvals and commercialization which are inherently uncertain, impacting investor confidence.
  • Market acceptance and competition in CNS disorder therapeutics, including treatments for suicidal ideation, may impact commercial success.

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