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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) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to a loss of $0.98 per share a year ago.
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”).