NRx Pharmaceuticals, Inc. (NRXP)’ NRX-100 Wins Expanded FDA Fast Track for Suicidal Depression

We recently compiled a list of the 13 Best Psychedelic Stocks to Invest in Now. NRx Pharmaceuticals, Inc. is one of them.

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, is focused on developing NMDA-based therapies for central nervous system disorders, including suicidal depression, chronic pain, and PTSD. Its lead candidates, NRX-100, a preservative-free intravenous ketamine formulation, and NRX-101, an oral combination therapy, are at the forefront of the company’s innovative approach. Recently, NRX-100 received an expanded FDA Fast Track designation for suicidal ideation across all depression types, broadening its potential U.S. patient base to around 13 million adults.

The company has also made significant regulatory progress. NRXP submitted manufacturing data supporting the New Drug Application (NDA) for NRX-101, which holds Breakthrough Therapy designation for suicidal bipolar depression. Additionally, an Abbreviated New Drug Application (ANDA) was filed for NRX-100 to provide a preservative-free alternative amid ongoing ketamine shortages in the U.S.

Beyond drug development, NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) is expanding its clinical footprint through its subsidiary HOPE Therapeutics, which recently acquired Dura Medical and is in the process of acquiring a stake in Cohen and Associates clinics. These moves aim to enhance interventional psychiatry services, strengthen patient care infrastructure, and drive revenue growth, creating a unique integrated model that combines therapeutic innovation with direct care delivery.

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