NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing
NRx Pharmaceuticals (NASDAQ: NRXP) announced plans to file two New Drug Applications (NDAs) in 2024. The first NDA for NRX-101 targets bipolar depression with akathisia, leveraging two positive trials and a Breakthrough Therapy Designation. The second NDA for NRX-100 (IV ketamine) addresses suicidal depression, backed by four positive trials and a Fast Track Designation. Both drugs could potentially generate significant revenue by 2025, with projected figures exceeding $150 per NRXP share. The company aims to complete the necessary 12-month stability data for both applications in 2024. Additionally, NRx is progressing towards the public listing of HOPE Therapeutics, pending completion of a public audit and SEC Form 10 review.
- Two NDAs planned for 2024 for NRX-101 and NRX-100, targeting significant mental health conditions.
- NRX-101 has demonstrated positive results in two clinical trials for bipolar depression with akathisia.
- NRX-100 (IV ketamine) has shown efficacy in four trials for suicidal depression.
- Potential revenue from these drugs could exceed $150 per NRXP share by 2025.
- NRX-101 awarded Breakthrough Therapy Designation and Fast Track Designation.
- Filing of NDAs depends on completion of 12-month stability data, which may delay the process.
- NRX-101 application to be filed without a commercial partner, potentially impacting market reach.
Insights
NRx Pharmaceuticals is making significant strides in the biopharmaceutical industry with the upcoming New Drug Applications (NDAs) for NRX-101 and NRX-100. These drugs target vastly different yet critical segments—bipolar depression with akathisia and suicidal depression, respectively. This dual approach has the potential to substantially impact the company's top-line revenue in the coming years.
Given the $150 potential revenue per share projected from these approvals, we must scrutinize this figure closely. This number implies a substantial rise in market capitalization, which could dramatically influence stock price if achieved. However, investors should consider this an ambitious estimate, contingent on market adoption rates, pricing strategies and competitive responses.
NRX-101's market scope for treating akathisia in bipolar patients is substantial. The $3.7 billion initial market for NRX-101 in akathisia and the broader $20 billion market for bipolar depression highlight its lucrative potential. Similar market dynamics exist for NRX-100, serving a $3-5 billion market for suicidal depression.
Strategic execution will be critical; the company plans to launch these drugs without a commercial partner. This entails higher costs and risks but could yield greater rewards if successful. Investors should be mindful of the operational and financial demands this strategy imposes, especially on a clinical-stage company.
Overall, the regulatory progress, substantial market opportunities and potential revenue projections make NRx Pharmaceuticals an interesting prospect for investment, albeit with inherent risks typical of the biopharma sector.
NRx Pharmaceuticals' advancement in filing NDAs for NRX-101 and NRX-100 is impressive. These applications build on robust clinical data, with NRX-101 demonstrating efficacy in treating bipolar depression with reduced suicidality and akathisia and NRX-100 showing promise for suicidal depression.
The Breakthrough Therapy Designation and Fast Track Designation granted to these drugs reflect their potential to address unmet medical needs swiftly. The 12-month stability data required for filing is a standard FDA prerequisite, ensuring the drugs' long-term efficacy and safety. This is vital information for investors, indicating that the company is adhering to rigorous regulatory standards.
From a clinical perspective, the lack of FDA-approved oral agents for treating akathisia gives NRX-101 a distinct advantage. Similarly, NRX-100's approach to suicidal depression leverages existing treatment paradigms (IV ketamine), filling a significant therapeutic gap not covered by FDA-approved products (excluding ECT).
These clinical advancements suggest that NRx is well-positioned to impact patient care substantially. However, the commercial success will depend on physicians' acceptance and integration into existing treatment protocols, which can sometimes be a slow process.
In summary, the clinical significance of these drugs provides a strong foundation for NRx Pharmaceuticals, offering both therapeutic and commercial potential. Investors should watch for the successful completion of the NDA processes and subsequent market uptake.
- New Drug Application (NDA) for Accelerated Approval planned for NRX-101 in people with bipolar depression and akathisia in 2024, based on two positive trials 1 2 and Breakthrough Therapy Designation. Potential revenue in 2025
- NDA for NRX-100 (IV ketamine) in suicidal depression in advanced preparation for submission in 2024; based on four positive trials 3 4 5 6 and Fast Track Designation. Potential revenue in 2025
- Gaining these approvals has the potential to yield more than
$150 - Planning for HOPE Therapeutics share distribution progresses; audit nearing completion – critical step towards a public listing
While efficacy and safety data are now in hand, filing of the above applications is dependent upon completion of 12-month stability data in manufactured lots as required by FDA regulations.
As disclosed in an 8K filing, NRx will be filing the NRX-101 application without a commercial partner. The addressable market for the accelerated approval indication is such that a compact and efficient salesforce can be constructed by a small company, such as NRx, and current executives at NRx have previously held primary responsibility for launch of similar-sized pharmaceutical assets.
NRx continues work to enable the distribution of shares in Hope Therapeutics. This distribution is dependent upon completion of a public audit and successful review of an SEC Form 10.
"The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner."
NRX-101 for Bipolar Depression
NRX-101 is the Company's patented (Composition of Matter), oral combination of the NMDA antagonist D-cycloserine and lurasidone for bipolar depression. Data from two active control clinical trials vs. the standard of care, lurasidone, have shown comparable antidepressant efficacy with clinically important reductions in suicidality and/or akathisia. To the Company's knowledge, no other oral agent has demonstrated such a valuable profile.
Up to
NRX-101 was awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression.
NRX-100 (IV ketamine) for Suicidal Depression
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by FDA is electroconvulsive therapy (ECT).
According to the CDC, 3.5 million Americans make a plan for suicide each year.8 This represents a
Based on the data in the trials referenced above, the Company's regulatory counsel has encouraged the Company to file an NDA for suicidal depression for NRX-100. This application has been in development and awaits 12-month stability data for filing, which is expected in 2024.
About NRx Pharmaceuticals
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-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) in 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 agreements. 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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, STABIL-B
2 Nierenberg, et. al., A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior. Am Soc Clin Psych Annual Meeting 2024. ASCP Poster
3 Fava, M et. al., Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD) Mol Psychiatry. 2020; 25(7): 1592–1603.
4 Grunebaum, et. al., Ketamine for Rapid Reduction of Suicidal Thoughts. Am J Psychiatry. 2018 Apr 1: 175(4): 327-335
5 Abbar, et. al. Ketamine for Acute Treatment of Severe Suicidal Ideation, BMJ 2022; 376
6 Anand, et. al, Ketamine is non-inferior to ECT for non-psychotic treatment resistant depression. NEJM 2023 388(25):2315-2325
7 Chow, C, et. Al., Akathisia and Newer Second-Generation Antipsychotic Drugs: A Review of Current Evidence
Pharmacotherapy 2020;40(6):565–574
8 CDC Suicide Data.
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SOURCE NRx Pharmaceuticals, Inc.
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