NRx Pharmaceuticals, Inc. reports clinical, regulatory, manufacturing, and subsidiary developments for a biopharmaceutical business focused on neuroplastic therapies for depression, PTSD, suicidality, and related conditions. Company updates center on NRX-100 preservative-free ketamine, NRX-101 as a D-cycloserine/lurasidone fixed-dose combination, FDA communications, generic-drug and new-drug application pathways, and clinical work involving treatment-resistant depression and suicidality.
Recurring news also covers commercial manufacturing preparations, drug-shortage context for ketamine injection, robotic-enabled transcranial magnetic stimulation initiatives through NRx Defense Systems, and interventional psychiatry activity through HOPE Therapeutics. Additional company developments include partnerships involving digital monitoring tools, leadership appointments, and research programs serving military, first-responder, and broader behavioral-health settings.
NRx Pharmaceuticals (Nasdaq: NRXP) reported second quarter 2026 results and a corporate update, highlighting progress on preservative-free ketamine, NRX-101, and its NMDA-based CNS pipeline. The FDA completed first-cycle review of the ANDA for preservative-free ketamine with no drug-related major deficiencies; a requested manufacturer attestation on the vial has been submitted, and commercial-scale manufacturing has begun, targeting 5 million launch doses and ongoing production of 1 million units per month with an approval and commercialization goal in 2026.
According to the company, it is advancing an NDA for NRX-100 for depression using Real World Evidence from more than 65,000 patients, aiming for 2027 approval. NRx was selected by DARPA as prime contractor for the SPARC-TMS Phase 2/3 trial of NRX-101 with robotic TMS, with anticipated non-dilutive funding exceeding $11.5 million, subject to contracting. The company also backed the formation of Geneuro, Inc. with two clinical-stage monoclonal antibodies.
For the six months ended June 30, 2026, NRx reported a net loss of $18.0 million versus $23.1 million a year earlier, and an operating loss of $11.3 million versus $7.6 million. Cash and equivalents were $26.7 million at June 30, 2026, up from $7.8 million at December 31, 2025, primarily from a public offering of common stock that raised gross proceeds of about $22.3 million. Management believes current cash, anticipated clinic revenue and its at-the-market facility will fund operations for at least one year.
NRx Pharmaceuticals (Nasdaq: NRXP) will host a conference call and Q&A on Monday, August 10, 2026 at 8:30 a.m. ET to discuss the FDA’s completion of first-cycle review of its ANDA for preservative-free ketamine. CEO Jonathan Javitt, Chief Commercial Officer Glenn Tyson, and Director Chaim Hurvitz will participate. Investors can join via live webcast on the company’s investor relations site or by domestic and international dial-in, with a replay available. NRx is a clinical-stage biopharmaceutical company developing NRX-100 (preservative-free IV ketamine) and NRX-101, both holding FDA Fast Track or Breakthrough Therapy designations for suicidal depression.
NRx Pharmaceuticals (Nasdaq: NRXP) reported that the FDA has completed first-cycle review of its ANDA for preservative-free intravenous ketamine with no major deficiencies related to the drug product, ingredients, proposed labeling, CMC, or other drug-related review matters, and is not requiring new clinical, safety, or efficacy data.
The only remaining item is a packaging-related Major Deficiency: FDA requested manufacturer certification that the luer lock vial tip, already used in three approved ANDA products with 11.9 million complaint-free doses shipped in 12 months, is produced on the same lines and methods. NRx is submitting this attestation, and FDA committed to review it in the shortest possible cycle. NRx views this first-cycle outcome, achieved in a context where only 14–18% of ANDAs are typically approved in first cycle, as a key milestone that de-risks its path to potential approval and commercialization. The company will host a webcast on August 10, 2026 to discuss the update.
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NRx Pharmaceuticals (Nasdaq: NRXP) reported that subsidiary HOPE Therapeutics has treated its first patients using Zeta Surgical's FDA-cleared Zeta TMS Navigation System at clinics in West Palm Beach and Sarasota, Florida.
The AI-guided, sub-millimetric navigation is integrated into outpatient TMS workflows and supports NRx's planned SPARC-TMS trial of NRX-101 with robotic-enabled TMS for depression and suicidality.
Summary not available.
ZETA SURGICAL and HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), reported the first patient treated with the FDA-cleared Zeta TMS Navigation System at a Sarasota clinic on June 23, 2026.
Systems are installed in Sarasota and West Palm Beach, using AI-based RealTrack™ image guidance for sub-millimetric TMS targeting in treatment-resistant depression and other neuropsychiatric conditions.
NRx Pharmaceuticals (Nasdaq: NRXP) received FDA authorization for an Intermediate Population Expanded Access Protocol for NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, to augment accelerated Transcranial Magnetic Stimulation (TMS) in Treatment-Resistant Depression.
The company has also initiated the pivotal SPARC-TMS trial in civilian and military settings and will initially provide NRX-101 under expanded access at no cost other than shipping and FDA-required data collection.
NRx Pharmaceuticals (Nasdaq: NRXP)/b) highlighted a peer-reviewed poster presented at the 2026 American Society of Clinical Psychopharmacology conference. The Osmind/Yale study used Real World Evidence from 8,224 IV ketamine and 1,830 intranasal esketamine patients with treatment-resistant depression.IV ketamine showed higher remission (34% vs 26%) and response (63% vs 58%) rates, with odds ratios of 1.51 for remission and 1.22 for response. Authors stressed key limitations, including non-randomized treatment assignment and data drawn only from clinics using Osmind’s electronic medical record system.
NRx Pharmaceuticals (Nasdaq: NRXP) closed a public offering of common stock at $3.50 per share, raising approximately $22.3 million in gross proceeds, including the underwriters’ option. The company plans to use net proceeds for working capital and general corporate purposes to support growth.