NRx Pharmaceuticals' Disruptive ONE-D TMS Protocol and Expansion Strategy in Florida: A High-Conviction Play in Mental Health Innovation

The $2.1 billion suicidal depression market, as highlighted in a HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. announcement, is witnessing a seismic shift as NRx Pharmaceuticals (NASDAQ:NRXP) advances its ONE-D TMS protocol-a single-day transcranial magnetic stimulation (TMS) treatment augmented by D-cycloserine (DCS) and lisdexamfetamine. With nonrandomized trial data showing an 87% response rate and 72% remission rate at six weeks, as reported in the HOPE Therapeutics, Inc. announcement, the protocol represents a bold departure from conventional TMS regimens, which typically require weeks of sessions. Coupled with a strategic acquisition-driven expansion in Florida's mental health market, NRx is positioning itself as a disruptive force in a sector starved for rapid-acting, scalable solutions.

Clinical Differentiation: A Neurostimulation Revolution

NRx's ONE-D TMS protocol leverages the FDA-cleared Ampa device, as detailed in the HOPE Therapeutics, Inc. announcement, but introduces a proprietary combination of pharmacological adjuncts. By pairing TMS with DCS-a drug shown to enhance synaptic plasticity-and lisdexamfetamine, the company claims to amplify therapeutic efficacy. According to nonrandomized data, this approach achieves remission in 72% of patients within six weeks, as reported in the HOPE Therapeutics, Inc. announcement, a stark contrast to traditional TMS, which typically reports remission rates of 30–50%, according to the NRx Pharmaceuticals acquisition announcement. While randomized trials are pending, the protocol's integration of DCS aligns with emerging evidence that the drug can "more than double the clinical effectiveness of TMS," as discussed in the NRx presentation at Noble Capital Markets, offering a compelling value proposition for treatment-resistant depression.

The clinical innovation extends beyond ONE-D. NRx's pipeline includes NRX-101, an oral antidepressant with Breakthrough Therapy Designation, which demonstrated suicidality reduction in bipolar depression, as noted in the NRx investor release. This dual-pronged strategy-neurostimulation and pharmacology-positions NRx to dominate multiple facets of the CNS disorder market.

Strategic Expansion: Florida as a Launchpad

NRx's commercialization strategy hinges on geographic dominance. In October 2025, the company acquired Cohen and Associates, LLC, a Sarasota-based interventional psychiatry clinic specializing in TMS and ketamine, as detailed in the HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. announcement. This acquisition not only expanded HOPE Therapeutics' Florida footprint but also brought Dr. Rebecca Cohen, a TMS expert, into a leadership role as Medical Director, as detailed in the HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. announcement. The move is emblematic of NRx's "hub-and-spoke" model: integrating high-performing clinics into its network to accelerate patient access and revenue growth.

By year-end 2025, the Ampa device will be deployed at six HOPE locations in Florida, as reported in the HOPE Therapeutics, Inc. announcement, with plans to expand further into Western Florida and Palm Beach, as noted in the HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. announcement. This geographic consolidation is critical in a market where insurance reimbursement and patient volume are tightly linked to regional penetration. Florida's aging population and high prevalence of mental health disorders, as discussed in the NRx presentation at Noble Capital Markets, make it an ideal testing ground for scaling the ONE-D model.

Regulatory Progress and Risks

While the ONE-D TMS protocol remains unsubmitted to the FDA, as noted in the HOPE Therapeutics, Inc. announcement, NRx's broader regulatory momentum is robust. NRX-100, its intravenous ketamine product, received Fast Track designation in August 2025, as reported in the NRx investor release, supported by trials showing 63% remission from suicidal ideation in three days, as noted in the NRx investor release. This regulatory validation underscores the company's ability to navigate the FDA's accelerated pathways-a critical asset in a market where speed to market is paramount.

However, risks persist. The ONE-D TMS data is nonrandomized, as reported in the HOPE Therapeutics, Inc. announcement, and the absence of an FDA submission raises questions about long-term commercial viability. Additionally, competition from established players like Brainsway and Neuronetics could challenge NRx's market share. Yet, the company's integrated approach-combining cutting-edge neurostimulation with a robust drug pipeline-creates a moat that is difficult to replicate.

Conclusion: A High-Conviction Play

NRx Pharmaceuticals is threading the needle between clinical innovation and commercial execution. The ONE-D TMS protocol, if validated in randomized trials, could redefine treatment paradigms for suicidal depression. Meanwhile, its Florida expansion strategy-bolstered by strategic acquisitions and a seasoned leadership team-provides a scalable blueprint for national rollout. For investors, the company's dual focus on regulatory breakthroughs (e.g., Fast Track for NRX-100) and market capture in a $2.1 billion sector, as highlighted in the HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. announcement, makes it a compelling, albeit high-risk, high-conviction play.