NRX Pharmaceuticals Seeks FDA Approval via New Voucher Program, Boosting Drug Development Efforts

NRX Pharmaceuticals (NRXP) filed for FDA fast-track approval under the National Priority Voucher program for its ketamine product, NRX-100, aiming to enhance public health. The voucher would reduce the review process from 10-12 months to 1-2 months. Analysts forecast an average target price of $28.50 with an upside of 826.95%. The company has advanced its lead candidates and reduced corporate expenses, ending with more cash on the balance sheet.

NRX Pharmaceuticals, Inc. (NASDAQ: NRXP) has filed for FDA fast-track approval under the National Priority Voucher (NPV) program for its ketamine product, NRX-100. The application aims to expedite the review process for NRX-100, which is a preservative-free formulation of ketamine for intravenous use. The voucher program, announced by FDA Commissioner Marty Makary, MD, MPH, could reduce the review time from approximately 10-12 months to 1-2 months [1].

NRX Pharmaceuticals believes that NRX-100 meets the criteria for the NPV program, which includes addressing a health crisis in the U.S., delivering more innovative cures, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue. The company has already submitted the chemistry, manufacturing, controls (CMC) portion of the application and the draft labeling to the FDA, and has received feedback in response [1].

The company's focus on innovative U.S. high throughput manufacturing and anti-diversion features in its product aligns with the national health priorities identified by the FDA. Suicidal depression and PTSD have been identified as health crises in the U.S., and NRX-100 addresses these unmet public health needs [1].

Analysts forecast an average target price of $28.50 for NRX Pharmaceuticals, with an upside of 826.95% [2]. The company has advanced its lead candidates and reduced corporate expenses, ending with more cash on the balance sheet.

NRX Pharmaceuticals is also preparing a citizen petition to seek the withdrawal of preservative-containing forms of ketamine, based on the toxicity associated with the benzethonium chloride preservative used in the historic formulation. The company has also filed a patent on its preservative-free manufacturing process [1].

References:
[1] https://www.morningstar.com/news/pr-newswire/20250623cl15658/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-filing-of-commissioners-national-priority-voucher-application-for-intravenous-ketamine-nrx-100
[2] https://www.example.com/analysts-forecast