NRXP

NRx Pharmaceuticals, Inc. (NRXP) Q2 2026 Earnings Call Transcript

Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company's ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA.

NRx Pharmaceuticals, Inc. (NRXP) Discusses FDA First Cycle Review Outcome and Commercialization Plans for Preservative Free Ketamine Transcript

NRx Pharmaceuticals NASDAQ: NRXP said it has completed the first-cycle U.S. Food and Drug Administration review of its abbreviated new drug application, or ANDA, for preservative-free ketamine, with one remaining issue related to the product's vial connector.

MIAMI, Aug. 07, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a conference call and Q&A session on Monday, August 10, 2026 at 8:30 a.m. Eastern Time to discuss the FDA's completion of first-cycle review of the Company's ANDA for preservative-free ketamine, announced earlier today.

FDA identified no major deficiencies related to the ketamine drug product, ingredients, proposed labeling, CMC, or other drug-related review matters. Remaining item relates to manufacturer certification for a luer lock vial already used in three FDA-approved ANDA products with 11.9 million units shipped over the past 12 months without complaints, returns, adverse events, or recalls.

WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx” or the “Company”) today issued the following statement in response to recent public claims made by Kadima Neuropsychiatry Institute (“Kadima”).

First Zeta-navigated TMS treatments have begun at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida, marking the transition from research deployment to active patient care AI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for patients with Major Depressive Disorder and other CNS conditions Milestone advances HOPE's interventional psychiatry platform and aligns with NRx's planned trial of NRX-101 in combination with robotic-enabled TMS in civilian and military treatment facilities (the SPARC-TMS trial). WILMINGTON, Del.

SAN DIEGO--(BUSINESS WIRE)--Kadima Neuropsychiatry Institute and its founder, Dr. David Feifel, have filed a complaint against NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and two of its subsidiaries in San Diego County Superior Court, alleging breach of contract and misrepresentation in connection with an acquisition agreement that the defendants warranted they had the financial capacity to close. The planned transaction represents a significant percentage of NRx's current market capitalization. T.

SARASOTA, Fla, and BOSTON, June 23, 2026 /PRNewswire/ -- ZETA SURGICAL and HOPE Therapeutics, an NRx Pharmaceuticals company (Nasdaq: NRXP), today announced the first patient treatment with the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota. HOPE has installed Zeta TMS Navigation Systems at clinics in West Palm Beach and Sarasota, with Zeta-navigated patient treatments beginning at both locations this week.