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NRx Pharmaceuticals (NASDAQ: NRXP) picked for DARPA SPARC-TMS trial talks

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

NRx Pharmaceuticals, Inc., through its Florida-based subsidiary NRx Defense Systems, Inc., received a July 21, 2026 letter from the Defense Advanced Research Projects Agency (DARPA) Defense Sciences Office stating that its proposal for a clinical trial titled Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) has been selected for negotiation of a potential award.

The SPARC-TMS study uses robotic-enabled Transcranial Magnetic Stimulation combined with NRX-101 (D-cycloserine/lurasidone) to evaluate remission from depression. The protocol is approved by the FDA as a phase 2/3 trial and is listed on ClinicalTrials.gov as NCT07227103. Planned sites include Harvard McLean Hospital, HOPE Therapeutics clinics, and military treatment facilities such as Walter Reed National Military Medical Center. NRX-101 is patented by the company and previously received FDA Breakthrough Therapy Designation. DARPA’s selection is only for contract negotiations and is not an award, funding commitment, or authorization to incur costs; any award would depend on successfully negotiating definitive terms.

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Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Trial phase phase 2/3 FDA-approved protocol stage for the SPARC-TMS clinical trial
ClinicalTrials.gov identifier NCT07227103 Registration ID for the SPARC-TMS depression trial
DARPA selection date July 21, 2026 Date NRX Defense Systems received DARPA’s negotiation letter
Transcranial Magnetic Stimulation medical
"combine D-cycloserine with Transcranial Magnetic Stimulation"
A noninvasive medical treatment that uses a changing magnetic field delivered through a coil placed near the head to stimulate specific areas of the brain, much like tapping a piano key to make a particular note play. Investors care because devices, clinical trial results, insurance coverage, and regulatory approvals determine commercial adoption and revenue potential for makers of the machines, clinics that offer the therapy, and related healthcare suppliers.
Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) medical
"clinical trial, entitled Synaptic Plasticity Augmented Rapid Circuit Stimulation"
Breakthrough Therapy Designation regulatory
"NRX-101 which is patented by the Company was previously awarded Breakthrough Therapy Designation"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
Defense Advanced Research Projects Agency (DARPA) regulatory
"letter from the Defense Advanced Research Projects Agency (DARPA), Defense Sciences Office"
The Defense Advanced Research Projects Agency (DARPA) is a government organization that develops innovative technology for national security purposes. It funds cutting-edge research to create breakthrough advancements, much like a research lab that pushes the boundaries of science. DARPA's work can influence broader technological progress, which may impact industries and markets beyond defense, making it relevant to investors monitoring innovation trends.

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FAQ

What is the SPARC-TMS trial described by NRXP?
The SPARC-TMS trial is an FDA-approved phase 2/3 study evaluating robotic-enabled Transcranial Magnetic Stimulation combined with NRX-101 to achieve remission from depression, listed on ClinicalTrials.gov under identifier NCT07227103.

What role does NRX-101 play in NRXP’s DARPA-selected study?
NRX-101, a patented combination of D-cycloserine and lurasidone, will be used with Transcranial Magnetic Stimulation in the SPARC-TMS trial. It previously received FDA Breakthrough Therapy Designation for its potential therapeutic benefits.

Which institutions are expected to participate in NRXP’s SPARC-TMS trial?
The planned SPARC-TMS trial sites include Harvard McLean Hospital, clinics operated by HOPE Therapeutics, and designated military treatment facilities, including Walter Reed National Military Medical Center, subject to final arrangements.

Does DARPA’s selection guarantee funding for NRXP and NRX Defense Systems?
No. DARPA’s letter states that selection for SPARC-TMS is only for negotiation of a potential award. It is not a notice of award, funding commitment, or authorization to incur costs, and any award depends on successful negotiation of definitive terms.

What is NRX Defense Systems, the NRXP subsidiary mentioned in the filing?
NRX Defense Systems, Inc. is a Florida-based research and development subsidiary of NRx Pharmaceuticals tasked with developing neuroplastic treatments that combine D-cycloserine with robotic-enabled Transcranial Magnetic Stimulation for potential government and non-government R&D programs.
false 0001719406 0001719406 2026-07-21 2026-07-21
 
UNITED STATES 
SECURITIES AND EXCHANGE COMMISSION 
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT 
PURSUANT TO SECTION 13 OR 15(d) OF THE 
SECURITIES EXCHANGE ACT OF 1934
 
Date of Report (Date of earliest event reported) July 21, 2026
 
NRX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-38302
 
82-2844431
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification No.)
 
1201 Orange Street, Suite 600
Wilmington, Delaware 19801
(Address of principal executive offices) (Zip Code)
 
(484) 254-6134
(Registrant’s telephone number, including area code)
 
N/A
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.001 per share
 
NRXP
 
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
 
Item 8.01.
Other Events.
 
In April 2026, NRx Pharmaceuticals, Inc. (the “Company”) announced the incorporation of NRx Defense Systems, Inc. (“NRXD”), a Florida-based research and development subsidiary charged with the development of neuroplastic treatments that combine D-cycloserine with Transcranial Magnetic Stimulation (“TMS”) under robotic-enabled neuro-navigation, using already developed technology. The Company anticipated NRXD participating in future government and non-governmental research and development, based on phase I and II research conducted by the Company’s Chief Medical Innovation Officer.
 
On July 21, 2026, NRXD received a letter from the Defense Advanced Research Projects Agency (“DARPA”), Defense Sciences Office (DSO), notifying the Company that its proposal to conduct a clinical trial, entitled Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) had been selected by DARPA for negotiation of a potential award.
 
The protocol for the SPARC-TMS trial was approved as a phase 2/3 trial by the US Food and Drug Administration (FDA) and is posted on www.clinicaltrials.gov (NCT07227103). The trial aims to demonstrate the potential efficacy of robotic-enabled Transcranial Magnetic Stimulation combined with NRX-101 (combined D-cycloserine/lurasidone) in achieving remission from depression. NRX-101 which is patented by the Company was previously awarded Breakthrough Therapy Designation by the FDA. The study is planned to be conducted at Harvard Mclean hospital, at clinics operated by HOPE Therapeutics, and at designated military treatment facilities including the Walter Reed National Military Medical Center.
 
The selection of the Company’s proposal for contract negotiation does not constitute a notice of award, a commitment by DARPA to make an award or an authorization for the Company to incur costs. Any potential award remains subject to the successful negotiation of definitive terms between DARPA/DSO and NRXD.
 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
NRX PHARMACEUTICALS, INC.
 
 
 
 
Date: July 22, 2026
By:
/s/ Jonathan Javitt
 
 
Name:
Jonathan Javitt
 
 
Title:
Chief Executive Officer
 
 
 

Source: View Original Filing on SEC EDGAR

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