NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announces Completion of Twelve Months of Stability on the First Manufactured Commercial Scale Lot of NRX-100 (Ketamine)

Rhea-AI Summary

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced the completion of twelve months of stability on the first manufactured commercial scale lot of NRX-100 (Ketamine). This milestone supports the submission of an FDA New Drug Application for the use of intravenous ketamine to treat Suicidal Depression. NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic use.

Key points:

• No degradation of the active ingredient was observed during the stability testing
• Projected room temperature shelf stability in excess of three years
• Filing of the NDA for NRX-100 is on track for 2024
• NRX-100 could benefit the 3.8 million people who make a plan to commit suicide in the United States each year

Positive

• Completion of twelve-month stability testing for NRX-100 (Ketamine) commercial scale lot
• No degradation of active ingredient observed, supporting projected shelf stability over three years
• First preservative-free formulation of Ketamine, potentially reducing toxic side effects
• NDA filing for NRX-100 on track for 2024
• Potential to benefit 3.8 million people in the US who plan suicide annually

Negative

• None.

Insights

Medical Research Analyst

The completion of 12-month stability testing for NRX-100 (Ketamine) is a significant milestone for NRx Pharmaceuticals. This achievement supports the company's plan to submit a New Drug Application (NDA) to the FDA for using intravenous ketamine to treat suicidal depression. Key points to consider:

• NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects associated with preservatives in current preparations.
• The stability data shows no degradation of the active ingredient, suggesting a room temperature shelf life of over three years.
• This development is important for the 3.8 million people in the U.S. who plan suicide annually, as FDA approval could lead to insurance coverage for this treatment.
• The company is on track to file the NDA in 2024, which could potentially open up a significant market opportunity if approved.

While this news is promising, investors should note that FDA approval is not guaranteed and the timeline for potential commercialization remains uncertain. The market impact will depend on the success of the NDA submission and subsequent regulatory decisions.

Financial Analyst

This development represents a positive step for NRx Pharmaceuticals, but its financial impact should be viewed cautiously:

• With a market cap of only $18.7 million, NRXP is a micro-cap stock, which inherently carries high risk.
• The company is still in the clinical stage, meaning it likely has no significant revenue and is burning cash to fund R&D.
• If approved, NRX-100 could address a large market of 3.8 million potential patients annually in the U.S. alone.
• However, the path to commercialization is long and uncertain, with the NDA filing planned for 2024 and potential approval timeline unknown.
• Investors should consider the company's cash position and burn rate, as additional funding may be needed before potential product launch.

While this news is positive for NRXP's development pipeline, the stock remains speculative. Investors should carefully weigh the potential upside against the significant risks associated with early-stage biotech companies.

• Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal Depression
• Ketamine is currently used off-label for this indication. However, FDA approval is typically required for patients to obtain insurance reimbursement
• NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic use

RADNOR, Pa., Sept. 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, ("NRx," the "Company"), today announced that twelve-month real-time stability on the first manufactured lot of NRX-100 (Ketamine) at Nephron Pharmaceuticals, utilizing commercial scale processes, was reached on September 24, 2024. In this process, no degradation of the active ingredient was observed. These findings are consistent with projected room temperature shelf stability in excess of three years. Accelerated stability on additional manufactured lots of preservative-free product is congruent with stability seen in this initial lot.

Demonstrating the ability to manufacture drug product, and prove its stability, are critical components of the drug approval process with the US FDA.  Filing of the NDA for NRX-100 is on track for 2024. The NRX-100 formulation is the first sterile, single dose vial prepared with without the addition of preservatives, which may have toxic effects with repeated use.

"We are pleased to reach this important milestone in our preparation of the NDA for NRX-100, a drug we believe can significantly benefit the 3.8 million people who make a plan to commit suicide in the United States each year¹," said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals.  "I would like to congratulate the manufacturing team from our partner Nephron Pharmaceuticals for helping us take this important step forward in bringing hope to life."

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 bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 inpatients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.

NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

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. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. 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. 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, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and 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.

CORPORATE CONTACTS: 
Jeremy Feffer, LifeSci Advisors, Inc.
jfeffer@lifesciadvisors.com 

Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-CEO, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com

_________________________
¹ https://www.cdc.gov/suicide/facts/data.html

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SOURCE NRx Pharmaceuticals, Inc.

FAQ

What is the significance of NRx Pharmaceuticals' (NRXP) 12-month stability milestone for NRX-100?

The 12-month stability milestone supports the submission of an FDA New Drug Application for NRX-100 (Ketamine) to treat Suicidal Depression. It demonstrates the product's stability and is a critical component of the drug approval process.

How does NRX-100 differ from current ketamine preparations?

NRX-100 is the first preservative-free formulation of Ketamine, which may avoid toxic side effects associated with preservatives used in current preparations designed for single dose anesthetic use.

When is NRx Pharmaceuticals (NRXP) planning to file the NDA for NRX-100?

NRx Pharmaceuticals is on track to file the New Drug Application (NDA) for NRX-100 in 2024.

What is the potential market for NRX-100 according to NRx Pharmaceuticals (NRXP)?

According to NRx Pharmaceuticals, NRX-100 could potentially benefit the 3.8 million people who make a plan to commit suicide in the United States each year.