NRX Pharmaceuticals, Inc.
No SEC Form 4 filings for $NRXP in the last 30 days.
See all $NRXP insider activity →NRX Pharmaceuticals, Inc. (NRXP) filed an SEC Form 8-K — Results of Operations and Financial Condition. nrxp20260817_8k.htm false 0001719406 0001719406 2026-08-17 2026-08-17 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 repo
NRx Pharmaceuticals (NASDAQ:NRXP) said it submitted an FDA attestation for its preservative-free ketamine ANDA, describing it as a final verification step, though it has not received a new GDUFA action date. The company plans launch inventory of 4-5 million vials and expects shipping within days of approval. It targets hospitals and other settings and also plans branded NRX-100/NRX-101.
NRx Pharmaceuticals (Nasdaq: NRXP) said it will hold an Aug. 10, 2026 conference call to discuss the FDA’s completion of the first-cycle review of its ANDA for preservative-free ketamine and the company’s commercial plans. Executives including CEO Jonathan Javitt will participate. A webcast and replay will be available on the company’s site.
Over the past 7 days, alphai's AI scored 2 news stories mentioning NRXP (NRX Pharmaceuticals, Inc.). Coverage has skewed bullish: 1 bullish, 1 neutral, and 0 bearish.
Recent NRXP coverage spans regulation, financial news and earnings.
This filing signals a fresh earnings release, but the scraped text does not include the actual financial results or guidance details.
A near-term FDA decision for preservative-free generic ketamine plus scaled launch inventory can materially change near-term supply expectations and commercialization timing.
The FDA first-cycle ANDA review completion is a near-term regulatory milestone, with potential to shift approval timing expectations and commercial planning assumptions.
Regulatory risk is reduced materially, but commercialization timing hinges on packaging certification from the vial manufacturer.
Regulatory de-risking for NRXP’s preservative-free ketamine ANDA, with the remaining hurdle framed as packaging/container-closure certification rather than drug product CMC or clinical data.
alphai scores every news story that mentions NRXP with an AI model for sentiment and relevance, and aggregates insider trades from NRX Pharmaceuticals, Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
NRX Pharmaceuticals, Inc. (NRXP) filed an SEC Form 8-K — Results of Operations and Financial Condition. nrxp20260817_8k.htm false 0001719406 0001719406 2026-08-17 2026-08-17 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 repo
2 min readNRx Pharmaceuticals (NASDAQ:NRXP) said it submitted an FDA attestation for its preservative-free ketamine ANDA, describing it as a final verification step, though it has not received a new GDUFA action date. The company plans launch inventory of 4-5 million vials and expects shipping within days of approval. It targets hospitals and other settings and also plans branded NRX-100/NRX-101.
4 min readNRx Pharmaceuticals (Nasdaq: NRXP) said it will hold an Aug. 10, 2026 conference call to discuss the FDA’s completion of the first-cycle review of its ANDA for preservative-free ketamine and the company’s commercial plans. Executives including CEO Jonathan Javitt will participate. A webcast and replay will be available on the company’s site.
3 min readNRx Pharmaceuticals said the FDA completed its first-cycle review of its ANDA for preservative-free ketamine, with no major deficiencies in the drug product, labeling, or manufacturing controls. Approval is now contingent on certification of the luer lock vial packaging. The company cited testing and shipment history and plans a call Aug. 10.
4 min readNRx Pharmaceuticals (Nasdaq: NRXP) said the FDA completed the first-cycle review of its ANDA for preservative-free IV ketamine, finding no major deficiencies in the drug product, ingredients, labeling, or CMC. A remaining packaging-related issue concerns luer lock vial certification. FDA will review the requested manufacturer attestation in the shortest possible cycle. No new clinical data are required.
4 min readNRx Pharmaceuticals said its subsidiary HOPE Therapeutics has treated its first patients using Zeta Surgical’s FDA-cleared Zeta TMS Navigation System. HOPE installed systems in West Palm Beach and Sarasota, Florida, and began AI-guided, markerless TMS for major depressive disorder and other CNS conditions. NRx said this supports its planned NRX-101 plus robotic-enabled TMS SPARC-TMS trial.
4 min readThe article is largely promotional and does not provide verifiable details about NRx Pharmaceuticals. It states that NRx Pharmaceuticals (NRXP) closed an underwritten public offering of common stock at $3.50 per share, but it includes no offering size, proceeds, or investor impact data. The remainder focuses on AI-themed commentary and newsletter subscription offers.
4 min readNRx Pharmaceuticals (Nasdaq:NRXP) said Osmind presented a retrospective EHR study at the 2026 American Society of Clinical Psychopharmacology comparing IV racemic ketamine with intranasal esketamine in treatment-resistant depression. The analysis included 8,224 IV ketamine and 1,830 intranasal esketamine patients (matched to 3,560). Remission was 34% vs 26% and response 63% vs 58% (IV OR 1.22; P value not shown). The study was not randomized, limiting causal conclusions.
4 min readNRx Pharmaceuticals (Nasdaq: NRXP) said it closed its underwritten public offering of common stock at $3.50 per share, including the underwriters’ option. Gross proceeds were about $22.3 million before underwriting discounts and expenses. BTIG was lead bookrunning manager and Lucid joint bookrunning manager; proceeds will be used for working capital and general corporate purposes.
4 min readNRx Pharmaceuticals (NASDAQ: NRXP) is expected to reach profitability in 2026, within the next 12 months, according to four industry analysts. The clinical-stage biopharmaceutical company, which recorded a US$29m loss in 2025, is projected to achieve a US$97m profit in 2026, requiring an average annual growth rate of 48%. Despite having negative equity, the company is viewed as nearing a significant business achievement.
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