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NRX Pharmaceuticals (NRXP)

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Earnings summaries and quarterly performance for NRX Pharmaceuticals.

Recent press releases and 8-K filings for NRXP.

NRx Pharmaceuticals Submits 70,000 Patient Real World Data to FDA for NRX-100 Accelerated Approval
NRXP
Product Launch
New Projects/Investments
  • NRx Pharmaceuticals has licensed Real World Evidence (RWE) drawn from over 70,000 patients to support its application for Accelerated Approval of NRX-100 (preservative-free ketamine).
  • NRX-100 is being developed for the treatment of suicidal ideation in Depression and Bipolar Depression, an indication for which it has already received Fast Track Designation from the FDA.
  • A preliminary analysis of a subset of this RWE, presented by Osmind, documented rapid resolution of depression and suicidality with intravenous ketamine, and the full dataset will be presented to the FDA.
  • The submission of this RWE was enabled by an FDA policy change in September 2025 that allows the use of de-identified data.
Jan 14, 2026, 12:03 PM
NRx Pharmaceuticals Announces Elimination of All Balance Sheet Debt
NRXP
  • NRx Pharmaceuticals (NRXP) announced the elimination of all balance sheet debt by repaying the remaining $5.4 million debt to Anson Funds, LLC, through an equity conversion in common stock.
  • The company anticipates ending the 2025 calendar year with a balance sheet free of all debt.
  • This debt elimination is expected to position NRXP for accelerated growth in 2026, with potential drug approvals and clinic expansions.
Dec 29, 2025, 9:30 PM
NRx Pharmaceuticals Eliminates All Balance Sheet Debt
NRXP
Debt Issuance
Convertible Preferred Issuance
  • NRx Pharmaceuticals (Nasdaq: NRXP) has repaid its remaining $5.4 million balance sheet debt to Anson Funds, LLC.
  • The repayment was executed through equity conversion in common stock, with no additional warrants or adjustment provisions.
  • The company anticipates ending the 2025 calendar year with a balance sheet free of all debt.
  • This debt-free position is expected to set the stage for accelerated growth in 2026, with potential drug approvals and clinic expansions.
Dec 18, 2025, 12:05 PM
NRx Pharmaceuticals Provides Regulatory and Pipeline Update
NRXP
Product Launch
New Projects/Investments
Guidance Update
  • NRx Pharmaceuticals received FDA acceptance for its Abbreviated New Drug Application (ANDA) for Ketaphree, a preservative-free ketamine formulation, with a July 29, 2026, goal date for review completion.
  • The company aims to have at least one million doses of Ketaphree manufactured and ready to ship by July 2026, targeting the existing generic ketamine market estimated at $750 million annually.
  • NRx is advancing NRx-101 for suicidal bipolar depression, amending its Investigational New Drug file to include use with transcranial magnetic stimulation (TMS).
  • Recent findings indicate that low-dose D-cycloserine (in NRx-101) combined with a one-day TMS protocol resulted in an 87% clinical response and 72% remission from depression and suicidality, with a potential market exceeding $1 billion if approved.
Dec 2, 2025, 2:00 PM
NRx Pharmaceuticals Receives FDA Acceptance for KETAFREE ANDA and Advances NRx-101 Development
NRXP
Product Launch
New Projects/Investments
Guidance Update
  • NRx Pharmaceuticals announced the FDA has accepted its Abbreviated New Drug Application (ANDA) for KETAFREE, a preservative-free ketamine formulation, setting a review completion goal date of July 29, 2026.
  • The company plans to have at least one million doses of KETAFREE manufactured and ready to ship by July 2026, targeting a generic ketamine market estimated at approximately $750 million annually.
  • NRx Pharmaceuticals is progressing NRx-101, which, when its active ingredient is combined with transcranial magnetic stimulation (TMS), demonstrated an 87% clinical response and 72% remission from depression and suicidality in recent findings.
  • A confirmatory Phase 3 trial is planned for NRx-101 to augment TMS effects, with a potential market estimated in excess of $1 billion.
Dec 2, 2025, 2:00 PM
NRx Pharmaceuticals Receives FDA Acceptance for Ketamine ANDA and Updates NRx-101 Development
NRXP
Product Launch
New Projects/Investments
Guidance Update
  • The FDA has accepted NRx Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Ketaphree, a preservative-free ketamine formulation, setting a July 29, 2026, goal date for review completion.
  • NRx anticipates entering the existing generic ketamine market, projected at approximately $750 million annually, with plans to have one million doses of Ketaphree manufactured and ready to ship by July 2026, utilizing technology capable of producing over one million doses per month.
  • The company is advancing NRx-101 for suicidal bipolar depression and has amended its Investigational New Drug file to include its use with transcranial magnetic stimulation (TMS).
  • Recent real-world data showed that NRx-101's active ingredient, D-cycloserine, combined with a one-day TMS protocol, resulted in an 87% clinical response and 72% remission from depression and suicidality, with a potential market exceeding $1 billion for this indication.
Dec 2, 2025, 2:00 PM
NRXP Reports Q3 2025 Financials and Advances Drug Pipeline and Clinic Network
NRXP
Earnings
New Projects/Investments
Product Launch
  • NRx Pharmaceuticals reported its first-ever revenue of approximately $240,000 in Q3 2025, primarily from its newly acquired Hope Therapeutics clinics which began generating revenue on September 8, 2025. The company recorded a loss from operations of $4 million for the quarter, compared to a $3 million loss in Q3 2024.
  • As of September 30, 2025, NRx Pharmaceuticals held $7.1 million in cash and cash equivalents, with operating capital projected to fund drug development operations through 2026. The company anticipates growing its clinic network to six or more by year-end and expects significant revenue growth in future quarters.
  • The company is advancing drug approval applications for Ketaphree, NRx 100, and NRx 101. The FDA noted no significant deficiencies in the revised Ketaphree filing, and NRx 100 received expanded fast-track designation for suicidal ideation and depression.
  • Hope Therapeutics launched a one-day TMS treatment protocol in Florida, combining TMS with D-cycloserine (the active ingredient in NRx 101), which has shown an 87% treatment response and 72% remission from severe depression in real-world data.
Nov 17, 2025, 1:30 PM
NRx Pharmaceuticals Reports Q3 2025 Results and Progress on Drug Approvals and Clinic Expansion
NRXP
Earnings
New Projects/Investments
M&A
  • NRx Pharmaceuticals reported a loss from operations of $4 million for Q3 2025, compared to $3 million in Q3 2024, and generated its first-ever revenue of approximately $240,000 from its newly acquired Hope Therapeutics clinics.
  • The company is advancing multiple drug approval applications, including Ketaphree (preservative-free ketamine ANDA), which has no significant deficiencies noted by the FDA and is on track for a Q2 GDUFA date, and NRx 100 (NDA for suicidal ideation), which received expanded fast-track designation and is awaiting a Commissioner's National Priority Voucher Program decision.
  • Hope Therapeutics, the company's interventional psychiatry clinic network, began revenue generation on September 8, 2025, with the acquisition of Durra Medical and plans to expand from two to six or more clinics by year-end.
  • NRx Pharmaceuticals anticipates its current cash position of $7.1 million (or $10.3 million including a subscription receivable) will fund operations at least through Q2 2026.
Nov 17, 2025, 1:30 PM
NRx Pharmaceuticals Reports First Revenue in Q3 2025 and Advances Drug Pipeline
NRXP
Earnings
New Projects/Investments
M&A
  • NRx Pharmaceuticals reported its first-ever revenue of approximately $240,000 for Q3 2025, primarily from 22 days of operations of its newly acquired Hope Therapeutics clinics. The company recorded a loss from operations of $4 million for the quarter, an increase from $3 million in Q3 2024.
  • As of September 30, 2025, the company's cash and cash equivalents totaled $7.1 million, with an additional $3.1 million received in early October, bringing the total to $10.3 million. This capital is anticipated to fund operations through Q2 2026.
  • Significant progress was made on drug approval applications, with the Ketaphree ANDA filing receiving no significant deficiencies from the FDA and on track for a second-quarter GDUFA date. The NDA for NRx 100, targeting suicidal ideation, is nearing completion, incorporating 60,000 patient encounters of real-world data.
  • Hope Therapeutics, the interventional psychiatry clinic network, began revenue generation in September 2025 and aims to expand from two to six or more clinics by year-end, with potential future acquisitions representing over $20 million in annual revenue.
Nov 17, 2025, 1:30 PM
NRx Pharmaceuticals Discusses Pipeline, Market Opportunities, and Regulatory Timelines
NRXP
New Projects/Investments
Product Launch
Guidance Update
  • NRx Pharmaceuticals (NRXP) is advancing three lead programs, including NRX-100 (intravenous ketamine) with a fast-track designation for suicidal ideation and depression, targeting a >$2 billion market, and NRX-101 (D-cycloserine and lurasidone) with breakthrough therapy designation for suicidality and akathisia.
  • The company expects to launch Keta Free, a preservative-free generic ketamine for anesthesia and pain control, in H1 2026, addressing a $750 million market currently experiencing drug shortages.
  • NRXP is also developing a low-dose D-cycloserine for use with transcranial magnetic stimulation (TMS) for PTSD and depression, and is building Hope Therapeutics clinics to integrate various neuroplastic therapies.
  • The company emphasizes its focus on addressing suicide as a neurobiological disease and aims to secure FDA approval for drugs to prevent suicide, a condition currently lacking approved medications.
  • Obtaining a Commissioner's National Priority Voucher (CNPV) for NRX-100 could massively accelerate its regulatory timeline, with the standard fast-track NDA path estimated at six months.
Oct 8, 2025, 1:30 PM