$NRXP

NRx Defense Systems, a subsidiary of NRx Pharmaceuticals (NRXP), received an $11.18M DARPA contract to evaluate robotic magnetic stimulation with NRX-101 for treating resistant depression. The SPARC-TMS trial, led by Harvard, ASU, and others, aims to replicate 91% response rates from prior studies. Success could support FDA approval for NRX-101 in this indication.

NRx Pharmaceuticals (NRXP) received an earlier FDA goal date of Nov. 10 for its preservative-free ketamine application after the FDA reclassified a filing amendment from major to minor, reducing review resources. The company aims to address a drug shortage with this product, according to its CEO.

NRx Pharmaceuticals (NRXP) reported that the FDA reclassified its ANDA amendment for preservative-free ketamine from a Major to a Minor Amendment, revising the GDUFA goal date to November 10, 2026. The company expressed appreciation for the FDA's expedited process.

NRX Pharmaceuticals (NRXP) announced FDA reclassified its ANDA from Major to Minor Amendment, resetting GDUFA goal date to November 10. The company's P/S ratio is 30.5, below historical median of 42.3. GF Score is 31, indicating financial challenges but strong momentum. One premium guru holds and recently added to their position. NRXP focuses on developing therapeutics for CNS disorders and pulmonary diseases, with no meaningful product revenue.

NRx Pharmaceuticals' subsidiary GeNeuro received a European patent for GNK-301, a monoclonal antibody for ALS treatment. The patent adds to two U.S. patents. GNK-301 targets HERV K, linked to ALS. GeNeuro plans Phase 1 trials in 2027. NRXP stock closed at $3.40, down 1.18% in pre-market trading.

NRx Pharmaceuticals (NRXP) subsidiary HOPE Therapeutics begins deploying Zeta Surgical's FDA-cleared TMS Robotic System in Florida clinics. The AI-driven system offers submillimeter precision for treating depression. This supports NRx's SPARC-TMS trial with NRX-101, involving military and civilian sites.

NRx Pharmaceuticals (NRXP) disputes Kadima's claims over a failed acquisition, citing a binding arbitration agreement and unmet closing conditions. NRx argues the acquisition is immaterial to its business. The dispute involves an agreement executed in May 2025. NRx is advancing initiatives like a partnership with Zeta Surgical and the SPARC-TMS trial. The company maintains the dispute is non-material to its financial outlook.

NRx Pharmaceuticals (NRXP) targets 2026 FDA approval for KETAFREE, its preservative-free ketamine product, with one remaining deficiency in review. The company ordered 5M units for launch and estimates a $750M market. NRx also advances a 400-patient DARPA-backed trial for NRX-101 and aims for 2027 approval of NRX-100. Q2 2026 net loss improved to $18M, with $26.7M cash on hand.

NRx Pharmaceuticals (NRXP) reported Q2 2026 results, highlighting FDA progress for preservative-free ketamine, $22.3M raised, and DARPA funding potential. The company submitted the final FDA attestation, is manufacturing 5M doses, and expects approval in 2026. Cash reserves support operations for at least a year.

NRx Pharmaceuticals (Nasdaq: NRXP) reported Q2 2026 results for the quarter ended June 30, 2026 and said its preservative-free ketamine ANDA faces one FDA major deficiency on a vial luer lock attestation, with a 2026 approval target. It reported six-month net loss of $18.0M and cash of $26.7M after a $22M+ offering.