NRx Pharmaceuticals' HOPE Therapeutics Secures Florida Regulatory Clearance for Dura Medical Acquisition

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), through its wholly owned subsidiary HOPE Therapeutics(TM), Inc., has achieved a significant milestone by securing final clearance from the Florida Agency for Health Care Administration to proceed with the acquisition of Dura Medical LLC. This move is pending the fulfillment of customary conditions. Dura Medical, established in 2018, operates clinics on Florida's west coast, specializing in mental health and chronic pain treatment. The clinics offer a range of therapies including Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato(R), Stellate Ganglion Blocks, and Traumatic Incident Reduction Therapy. Additionally, Dura serves veterans through the Veterans Affairs Community Cares Network.

The acquisition by HOPE Therapeutics is poised to expand its Florida network significantly. It also aims to integrate Dura's specialized expertise in combining psychedelic medications with neuroplastic technologies for the treatment of conditions such as suicidal depression and PTSD. This strategic acquisition underscores NRx Pharmaceuticals' commitment to advancing treatments for central nervous system disorders. The company is currently developing NRX-101, an FDA-designated investigational Breakthrough Therapy, targeting suicidal treatment-resistant bipolar depression. Furthermore, NRx has plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia.

In addition to its developments with NRX-101, NRx Pharmaceuticals has filed for a new Commissioner's National Priority Voucher (CNPV) for NRX-100, a preservative-free IV ketamine. The CNPV is designed to expedite the approval of drugs that enhance the health interests of Americans. The company has also submitted an Abbreviated New Drug Application (ANDA) for NRX-100 for its currently approved indications and initiated a New Drug Application for the treatment of suicidal depression. These efforts are supported by data from well-controlled clinical trials and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx's dedication to innovation in mental health treatment is further evidenced by its receipt of Fast Track Designation from the US FDA for the development of ketamine (NRX-100) as part of a protocol to treat patients with acute suicidality.

For more information on NRx Pharmaceuticals and its developments, visit https://ibn.fm/NRXP. This acquisition marks a pivotal step in NRx Pharmaceuticals' mission to address some of the most challenging mental health conditions through innovative treatments and therapies.