NRx Pharmaceuticals to discuss new NRX-101 pipeline indication for augmentation of Transcranial Magnetic Stimulation

Rhea-AI Summary

NRx Pharmaceuticals (Nasdaq: NRXP) amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to add use in combination with Transcranial Magnetic Stimulation (TMS) for treatment of depression, including suicidal depression, and will offer the protocol via clinical trial and Expanded Access.

Company holds >25,000 investigational doses, cites prior studies reporting 75% response/40% remission (Cole et al.) and real-world data with 87% response/72% remission at 6 weeks after a single-day TMS+DCS regimen, and says NRX-101 has composition-of-matter patents and Breakthrough Therapy designation.

Positive

• IND amended to include NRX-101 with TMS
• >25,000 manufactured investigational doses available
• Published studies report 75% response/40% remission with DCS+TMS
• Real-world data report 87% response/72% remission at 6 weeks
• NRX-101 has composition-of-matter patents in major jurisdictions
• Drug holds Breakthrough Therapy designation

Negative

• D-cycloserine has known low-grade hallucination risk and prior contraindication
• Efficacy must be replicated in registration trials (company cites ~120 participants)

News Market Reaction

+6.17%

1 alert

+6.17% News Effect

On the day this news was published, NRXP gained 6.17%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Investigational doses: >25,000 doses Clinical response rate: 75% Remission rate: 40% +5 more

8 metrics

Investigational doses >25,000 doses Manufactured NRX-101 investigational supply

Clinical response rate 75% D-cycloserine + TMS group in Cole et al. study

Remission rate 40% D-cycloserine + TMS group in Cole et al. study

Real-world response 87% Theta Burst TMS + single oral D-cycloserine at 6 weeks

Real-world remission 72% Theta Burst TMS + single oral D-cycloserine at 6 weeks

Planned trial size ≈120 participants Proposed well-controlled NRX-101/TMS registration trial

SSRI success rate 30% Reported success rate with SSRI antidepressants

Projected TMS patients 1 million per year Expected Americans treated with TMS by 2030

Market Reality Check

Price: $2.10 Vol: Volume 406,343 is below t...

normal vol

$2.10 Last Close

Volume Volume 406,343 is below the 20-day average of 467,798, suggesting no outsized trading response before this news. normal

Technical Shares at $2.20 are trading below the 200-day MA of $2.64 and well under the $6.01 52-week high.

Peers on Argus

NRXP was down 5.96% while close peers were mixed: VANI (-6.08%), ABVC (-0.44%), ...

NRXP was down 5.96% while close peers were mixed: VANI (-6.08%), ABVC (-0.44%), SLGL (-3.86%), MGX (-2.25%), and IMMX up 8.21%, indicating stock-specific dynamics rather than a clear sector move.

Historical Context

5 past events · Latest: Dec 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Pipeline expansion	Positive	+6.2%	NRX-101 IND amended to add TMS augmentation indication for depression.
Dec 02	Regulatory filing	Positive	-5.0%	FDA receipt of ANDA for preservative-free ketamine KETAFREE™.
Dec 02	Corporate update call	Neutral	-5.0%	Announcement of conference call to review clinical and regulatory updates.
Dec 01	Conference presentation	Positive	-2.5%	NobleCon21 presentation on expanded focus and initial clinical revenue.
Nov 17	Earnings and update	Negative	-15.3%	Q3 loss, limited cash, but pipeline and clinic progress outlined.

Pattern Detected

Recent news often drew negative price reactions, even for seemingly positive regulatory and corporate updates, with only the current TMS-related NRX-101 update showing a positive move.

Recent Company History

Over the past months, NRXP combined clinical, regulatory, and corporate developments with financial strain. The Q3 2025 report highlighted a larger loss and going‑concern language, which coincided with a -15.26% move. Subsequent conference and corporate update news on Dec 1–2 saw modest declines despite highlighting pipeline and operational progress. The KETAFREE™ ANDA milestone on Dec 2 also aligned with a drop. In contrast, today’s NRX‑101/TMS pipeline indication news, citing high response and remission rates, previously coincided with a 6.17% gain.

Regulatory & Risk Context

Active S-3 Shelf · $150 million

Shelf Active

Active S-3 Shelf Registration 2025-06-20

$150 million registered capacity

NRXP has an effective mechanism to issue up to $150 million of securities under its Form S-3 shelf filed on June 20, 2025, providing flexible capital-raising capacity but also potential dilution and leverage considerations for existing shareholders.

Market Pulse Summary

The stock moved +6.2% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +6.2% in the session following this news. A strong positive reaction aligns with the article’s focus on NRX‑101 as an adjunct to TMS, supported by prior data showing up to 87% response and 72% remission. Historically, NRXP’s positive clinical or regulatory updates have not always produced gains, so a large advance would stand out versus past divergences. However, the presence of a $150 million shelf facility and the company’s broader funding needs could become key factors for how long elevated levels were sustained.

Key Terms

transcranial magnetic stimulation, investigational new drug, expanded access, breakthrough therapy, +4 more

8 terms

transcranial magnetic stimulation medical

"associated with augmentation of the antidepressant and antisuicidal response achieved by Transcranial Magnetic Stimulation (TMS)"

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.

investigational new drug regulatory

"NRx has amended its Investigational New Drug filing for NRX-101"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

expanded access regulatory

"available to patients both through a clinical trial and under NRx’s Expanded Access protocols"

Access that lets patients use an experimental drug or medical device outside of a formal clinical trial when no approved options are available. Think of it like allowing someone to test-drive a prototype car because they have no other transportation; for investors, expanded access can affect short-term demand, provide additional safety or usage information, and carry reputational or regulatory risks that may influence a company’s prospects and potential future sales.

breakthrough therapy regulatory

"rapid path to commercialization for this Breakthrough Therapy-designated drug"

A breakthrough therapy is a regulatory designation granted to an experimental drug or treatment when early clinical evidence indicates it could offer a substantial improvement over existing options for a serious or life‑threatening condition. For investors it matters because the label brings faster, more intensive interaction with regulators and can shorten development and review time—like a VIP fast‑track toward potential approval, reducing time and risk before a product can reach the market.

theta burst medical

"use of a modern Theta Burst FDA-cleared TMS device and a one day TMS protocol"

Theta burst is a specific pattern of brief, high-frequency pulses used in noninvasive brain stimulation to change how groups of nerve cells communicate. Think of it like a short, rhythmic tap that can either wake up or quiet down a part of the brain; for investors, its use in clinical trials or medical devices signals a pathway to new therapies, regulatory milestones, and potential market opportunity tied to neurological or psychiatric treatments.

hamilton depression rating scale medical

"manifesting at 6 weeks after a single day of treatment on the Hamilton Depression Rating Scale"

A clinician-administered questionnaire that rates the severity of a person’s depressive symptoms across mood, sleep, appetite and physical signs, producing a numeric score used to track change over time. Investors pay attention because these scores are often primary endpoints in clinical trials and can determine whether a treatment is seen as effective, influencing regulatory approval, prescribing use and the commercial value of mental-health therapies — like a standardized thermometer showing whether a treatment lowers the ‘fever’ of depression.

composition of matter patent regulatory

"drug combination, which has now obtained composition of matter patent protection"

A composition of matter patent is a legal right that protects a specific chemical, molecule, material or formulated mixture—think of it as locking down a unique recipe for a substance. For investors it matters because the patent can give a company exclusive control to make, sell, or license that substance, creating a potential source of revenue and a competitive barrier similar to owning the only map to a valuable resource.

ssri medical

"compares favorably to the 30% success rate now reported in association with SSRI antidepressants"

A selective serotonin reuptake inhibitor (SSRI) is a class of prescription drug that raises levels of serotonin, a brain chemical linked to mood, by slowing its reabsorption into nerve cells. Think of it as adjusting a thermostat to keep mood-regulating signals warmer for longer. Investors watch SSRIs because their approvals, patent status, safety signals or new clinical results can change sales, market share and the value of companies that develop or sell them.

AI-generated analysis. Not financial advice.

• As previously announced, low dose D-cycloserine has been associated with augmentation of the antidepressant and antisuicidal response achieved by Transcranial Magnetic Stimulation (TMS).
• NRx has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include its use in association with TMS for the treatment of depression, including suicidal depression. This protocol will be available to patients both through a clinical trial and under NRx’s Expanded Access protocols.
• NRx currently has more than 25,000 manufactured investigational doses available
  

WILMINGTON, Del., Dec. 03, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include the use of NRX-101 in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression.

In the third quarter, the Company identified a promising new indication for NRX-101 that potentially offers rapid path to commercialization for this Breakthrough Therapy-designated drug. Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation. Cole and colleagues reported that patients randomized to D-cycloserine (DCS) vs. Placebo concurrent with TMS using a standard protocol experienced a greater than two-fold benefit in terms of reduction in symptoms of depression. Clinical response of 75% and remission of 40% was seen in the DCS-treated group.¹ A substantial body of nonclinical literature has been published in subsequent years demonstrating that DCS at low doses exerts a neuroplasticity effect and causes dendritic sprouting in areas of the brain associated with depression.

On November 4, 2025, Real World Data were presented in conjunction with use of a modern Theta Burst FDA-cleared TMS device and a one day TMS protocol, combined with a single administration of oral DCS. The authors reported 87% clinical response and 72% remission manifesting at 6 weeks after a single day of treatment on the Hamilton Depression Rating Scale with similar findings on other standard test measures.²

Nonclinical evidence suggests that D-cycloserine acts to augment neuroplasticity in association with TMS. Should the findings of these two clinical studies be replicated in registration trials conducted to current regulatory standards, the Company anticipates D-cycloserine or similar medicines will become standard of care therapy in association with TMS. The response rate from TMS with cycloserine (>80%) in these two studies compares favorably to the 30% success rate now reported in association with SSRI antidepressants, without the well known side effects of SSRI medications.

In addition to containing D-cycloserine, NRX-101 contains a low dose of lurasidone, a medicine already approved for treatment of depression and known to have anti-hallucinatory properties. D-cycloserine by itself is well known to have a low, but measurable potential for inducing low-grade hallucinations, resulting in a labeled contraindication against the use of Seromycin^® (D-cycloserine) in patients with depression. This contraindication originally led the founders of NRx to develop and patent the NRX-101 drug combination, which has now obtained composition of matter patent protection in all major jurisdictions.

NRx believes that the clinical benefit demonstrated in these two published trials can be demonstrated in a well-controlled trials of approximately 120 participants. The Company is in partnership discussion with manufacturers of currently-marketed TMS devices to configure a joint clinical trial that will lead to drug registration and augmentation of FDA labeling of currently-approved TMS devices. Because TMS is already an approved and reimbursed therapy for patients with depression, the Company anticipates that such trials can be accomplished at modest expense.

Given current trends, the Company expects that more than 1 million Americans per year may be treated with TMS by the year 2030, creating a substantial new potential market for NRX-101 not previously anticipated. As required by law for Breakthrough Therapy drugs such as NRX-101, the Company has published an Expanded Access policy for this medication. Treating physicians who believe that their patients might benefit from NRX-101 in association with TMS may contact the Company for further information.

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 recently re-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:

Matthew Duffy		Brian Korb
Chief Business Officer, NRx		Managing Partner, astr partners
(646) 335-5923		(917) 653-5122
mduffy@nrxpharma.com		brian.korb@astrpartners.com

¹ Cole J, et.al. Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022;79(12):1153–1161. doi:10.1001/jamapsychiatry.2022.3255
² Vaughn, Donald & Marino, Brooke & Engelbertson, Alex & Dojnov, Aleksandra & Weiss, Nick & Vila-Rodriguez, Fidel & Nanos, Georgine & Downar, Jonathan. (2024). Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplastogen-Enhanced techniques in Depression (ONE-D). 10.21203/rs.3.rs-5679327/v1.

FAQ

What did NRx (NRXP) announce on December 3, 2025 about NRX-101 and TMS?

NRx announced it amended the NRX-101 IND to include use with TMS for depression, including suicidal depression, and will offer treatment in trials and Expanded Access.

How many NRX-101 investigational doses does NRx (NRXP) currently have available?

The company stated it currently has more than 25,000 manufactured investigational doses available.

What clinical response rates were reported for D-cycloserine plus TMS cited by NRx (NRXP)?

The cited studies reported a 75% clinical response and 40% remission in one trial and 87% response and 72% remission in real-world data at 6 weeks.

Will NRX-101 be available outside clinical trials under NRXP's plan?

Yes; the company said the protocol will be available both through a clinical trial and under its Expanded Access policy.

Does NRX-101 include other drugs besides D-cycloserine in NRXP's regimen?

Yes; NRX-101 combines low-dose lurasidone with D-cycloserine and the company cites patent protection for the combination.

What further evidence does NRx (NRXP) say is needed for NRX-101 with TMS to become standard of care?

The company said the findings must be replicated in registration trials conducted to current regulatory standards, estimating trials of about 120 participants.