Every 8-K that Nrx Pharmaceuticals Inc (NRXP) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow NRXP and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full NRXP filings page.
NRx Pharmaceuticals, Inc. reported financial results for the quarter and six months ended June 30, 2026, alongside a significant corporate update. For the six-month period, the company reported a net loss of $18.0 million compared with $23.1 million in 2025, while net operating loss increased to $11.3 million from $7.6 million due to higher R&D and commercial readiness expenses. Cash and cash equivalents rose to $26.7 million as of June 30, 2026 from $7.8 million at December 31, 2025, primarily driven by a public equity offering with more than $22 million in gross proceeds, supporting at least one year of operations.
The company advanced its ANDA for preservative-free ketamine, with the FDA citing no major drug or manufacturing deficiencies and only one container-related issue, which has been addressed. NRx is manufacturing 5 million units of launch stock with plans for 1 million units per month post-launch, targeting 2026 approval and commercialization. The NDA for NRX-100 is being finalized following federal support for using Real World Evidence, including data from 65,000 patients, with an approval goal in 2027. NRx was also selected as Prime Contractor for the DARPA SPARC-TMS phase 3 trial of NRX-101, potentially expanding its addressable depression market to more than 15 million Americans, and invested in Geneuro, Inc., gaining two clinical-stage monoclonal antibodies for ALS and other neurodegenerative and autoimmune conditions.
NRx Pharmaceuticals is updating investors on U.S. FDA review of its Abbreviated New Drug Application (ANDA) for preservative‑free ketamine. On July 30, 2026 the FDA reported no major deficiencies related to the drug components, but requested a label update to match the reference drug Ketalar and identified a single major deficiency concerning the twist‑off cap of the luer lock vial, which affects the container closure.
NRx highlighted performance testing on 3,500 vials from seven manufacturing batches and real‑world experience with 11.9 million doses of similar products using the same vial design, without complaints, returns, or recalls. After an August 6, 2026 clarification meeting, the FDA asked for formal manufacturer certifications that this product is made on the same lines and with the same materials as three approved ANDA products, then agreed to immediately reinitiate review focused on this packaging issue and to complete it in the shortest‑possible review cycle. Management notes ketamine’s presence on the FDA drug shortage list and expresses optimism about resolving the packaging concern and achieving initial commercial sales in 2026, while acknowledging that regulatory outcomes cannot be assured.
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.
NRx Pharmaceuticals completed an underwritten public offering of 5,714,286 shares of common stock at $3.50 per share, with underwriters granted a 30-day option for 857,142 additional shares. The company expects net proceeds of about $18.8 million, or $21.6 million if the option is fully exercised.
The gross proceeds described in related press releases were approximately $20.0 million at pricing and $22.3 million at closing, including full exercise of the underwriters’ option. NRx plans to use the cash for working capital and general corporate purposes to support its growth. Directors and executives agreed to a 60-day lockup on stock sales.
NRx Pharmaceuticals, Inc. plans an underwritten public offering of its common stock, using an already effective shelf registration statement on Form S-3. The company also expects to grant the underwriter a 30-day option to buy up to an additional 15% of the shares sold on the same terms. Net proceeds are currently intended for working capital and general corporate purposes to support the company’s growth. The transaction remains subject to market and other conditions, and there is no assurance on completion, timing, or final size.
NRx Pharmaceuticals, Inc. held its 2025 annual stockholder meeting, where investors approved an amendment to the 2021 Omnibus Incentive Plan. The change increases the annual “evergreen” share reserve to the lesser of 3,187,234 shares, 5% of fully diluted shares, or a lower amount set by the board.
Stockholders also elected Chaim Hurvitz and Michael Taylor as Class I directors to serve until the 2028 annual meeting, ratified Weinberg & Company, P.A. as auditor for 2025, and supported executive compensation in a non-binding advisory vote.
NRx Pharmaceuticals outlines a clearer regulatory path for its NRX-100 (preservative-free ketamine) program following an in-person Type C meeting with senior FDA leadership. Based on oral guidance, the company believes it can file a full New Drug Application using existing controlled trial data plus Real World Evidence from more than 65,000 patients in the Osmind database.
The company now plans to seek an indication for treatment-resistant depression in the context of suicidality, a broader target than suicidal ideation alone, and expects no additional nonclinical or bridging studies will be required. FDA will work with NRx and Osmind to finalize a statistical analysis plan for the Real World Evidence, which the company expects will be among the first such CNS applications under new guidance. Separately, NRx has filed an Abbreviated New Drug Application for a generic preservative-free ketamine for anesthesia and pain, with a planned FDA decision date in summer 2026.
NRx Pharmaceuticals, Inc. filed a prospectus supplement covering an at-the-market offering of up to $20,000,000 of its common stock. The shares may be issued from time to time under an existing At-The-Market Offering Agreement with H.C. Wainwright & Co., LLC.
The shares will be issued under the company’s effective Form S-3 shelf registration statement and related base prospectus. This report also files a legal opinion from Cozen O’Connor confirming the validity of the shares to be issued under the program.
NRx Pharmaceuticals, Inc. appointed Joseph M. Casper, age 75, as its Chief Operating Officer, effective January 27, 2026. He brings 35 years of healthcare experience, including senior roles advising major payer, provider, and academic medical center organizations and involvement in an early medical record aggregation platform used by more than 15 million patients.
Mr. Casper’s compensation includes an expected annual base salary of $250,000, a target bonus of 25% of base salary tied to agreed milestones, and 100,000 stock options vesting 33.3% on June 1, 2026, 33.3% on December 1, 2026, and 33.3% on December 1, 2027.
NRx Pharmaceuticals, Inc. reported that on January 12, 2026 it received a letter from Nasdaq stating the company is not in compliance with Nasdaq rules requiring an annual shareholder meeting within twelve months of the fiscal year ended December 31, 2024. The company has 45 calendar days to submit a plan to regain compliance, and Nasdaq may grant an exception of up to 180 days from fiscal year end, through June 29, 2026. The notice does not immediately affect trading of the NRXP common stock, but the company will be listed as non-compliant on Nasdaq’s website and market data feeds.
The board set March 23, 2026 as the date of the 2025 Annual Meeting, to be held virtually, with February 12, 2026 as the record date. Because this date is more than 60 days after the prior October 8, 2024 annual meeting, stockholders must submit most proposals or director nominations under the bylaws by the close of business on January 26, 2026 to be considered at the 2025 meeting.
NRx Pharmaceuticals, Inc. reported that its audit committee has appointed Weinberg & Company P.A. as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2025. Weinberg previously audited the financial statements of Dura Medical LLC, which was acquired by Hope Therapeutics, Inc., a subsidiary of NRx.
As part of this change, the audit committee dismissed Salberg & Company P.A. as the company’s independent auditor on or around November 24, 2025. Salberg’s audit reports on the December 31, 2024 and December 31, 2023 consolidated financial statements contained an explanatory paragraph about NRx’s ability to continue as a going concern, but no adverse opinions, disclaimers, or qualifications.
The company states there were no disagreements or reportable events with Salberg under SEC definitions during the past two fiscal years and through September 30, 2025. Salberg provided a letter to the SEC confirming its agreement with NRx’s description of the relationship and the change in auditors.
NRx Pharmaceuticals, Inc. filed an amended current report to add required financial information related to its acquisition of Dura Medical, LLC. The company previously reported the completion of this acquisition and is now providing Dura Medical’s standalone financial statements and combined pro forma financials.
The amendment includes audited financial statements of Dura Medical for the year ended December 31, 2024, unaudited financial statements as of and for the six months ended June 30, 2025, and unaudited pro forma combined financial statements showing NRx and Dura Medical on a combined basis. These materials are provided as exhibits and are incorporated by reference, while all other information from the original report remains unchanged.
NRx Pharmaceuticals (NRXP) reported that its subsidiary, HOPE Therapeutics, completed the acquisition of a strategic minority interest in Rebecca S. Cohen, MD, LLC d/b/a Cohen & Associates on October 17, 2025. The deal was executed under a Membership Interest Purchase Agreement with customary representations, warranties, indemnification, and post‑closing adjustments.
In connection with the transaction, Dr. Rebecca Cohen was appointed Medical Director of HOPE Therapeutics, with employment terms that include financial incentives to establish and grow new sites of care owned or operated by HOPE Therapeutics. The company also furnished a related press release as Exhibit 99.1.
NRx Pharmaceuticals, Inc. announced on September 24, 2025 that the U.S. Food and Drug Administration granted a Suitability Petition for the strength the company proposed for its planned single‑patient, preservative‑free ketamine product, KETAFREE™. The filing explains that currently marketed ketamine is supplied in multi‑dose vials containing the toxic preservative Benzethonium Chloride, and the granted petition permits immediate re‑filing of the company’s Abbreviated New Drug Application for KETAFREE™. The item notes the press release is furnished as Exhibit 99.1 and clarifies this disclosure is furnished, not "filed," under Exchange Act liability provisions.
NRx Pharmaceuticals reported that it recently raised an aggregate of approximately $8.8 million in gross proceeds from sales of common stock. The company clarified that this amount is comprised of gross proceeds from a registered direct common stock offering announced in August 2025 and from shares sold under its at-the-market (ATM) offering since the current fiscal quarter began on July 1, 2025. The company said these issuances included no warrants, repricing adjustments, or other variable rate features, and that the substantial majority of the proceeds were placed with experienced biotech investors. The disclosure notes the company will revert to reporting ATM gross proceeds in its quarterly reports and furnishes a related press release as an exhibit.
NRx Pharmaceuticals, Inc. entered a Securities Purchase Agreement on August 18, 2025 to sell 3,959,999 shares of common stock at $1.65 per share in a registered direct offering, producing approximately $6.5 million in gross proceeds if the offering closes on or about August 18, 2025. Purchasers signed one-year lock-up agreements preventing transfer of the shares without company consent until August 19, 2026. The shares are being offered under a prospectus supplement to the company’s Form S-3 declared effective on June 21, 2022. The company also furnished an earnings press release for the quarter ended June 30, 2025 as Exhibit 99.1.