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Investing.com - H.C. Wainwright has reiterated its Buy rating and $40.00 price target on NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), citing positive implications from a recent FDA approval for a competitor’s drug. According to InvestingPro data, NRXP has shown remarkable momentum with a 158% return over the past year, despite recent volatility. Analyst consensus remains strongly bullish, with price targets ranging from $25 to $46.
The firm views the October 10 FDA approval of Teva Pharmaceutical Industries’ supplemental New Drug Application for UZEDY as a favorable indicator for NRx’s regulatory prospects. The approval expanded UZEDY’s label to include maintenance treatment of adults with bipolar disorder I, beyond its original schizophrenia indication.
H.C. Wainwright noted this decision reinforces the FDA’s "increasingly pragmatic, data-integrated approach to neuropsychiatric drug reviews" and supports confidence in NRX-101’s accelerated-approval pathway for bipolar depression with suicidality and akathisia.
The approval also highlights FDA’s openness to model-informed development and real-world data integration, which are core elements of NRx’s regulatory strategy for both NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral fixed-dose D-cycloserine/lurasidone).
Multiple near-term catalysts for NRx include completion of the NDA for NRX-100, ongoing regulatory progress for NRX-101, and continued expansion of the HOPE Therapeutics platform, according to the research firm. With the next earnings report due on November 14, InvestingPro subscribers can access comprehensive analysis and 8 additional ProTips to better evaluate these catalysts’ potential impact on NRXP’s market position.
In other recent news, NRx Pharmaceuticals announced the re-filing of an Abbreviated New Drug Application (ANDA) for KETAFREE, a preservative-free intravenous ketamine formulation. This move comes amid a national ketamine shortage, with the company seeking priority review from the FDA. The FDA had previously granted a Suitability Petition for KETAFREE, allowing NRx to proceed with the application. H.C. Wainwright has reiterated a Buy rating for NRx Pharmaceuticals, maintaining a price target of $40.00, and highlighted the potential for KETAFREE to receive expedited review. Additionally, NRx Pharmaceuticals’ subsidiary, HOPE Therapeutics, completed the acquisition of Dura Medical to expand mental health services in Florida. This acquisition is part of a broader strategy to establish a network of mental health treatment locations. H.C. Wainwright also assumed coverage on NRx Pharmaceuticals, citing its dual strategy of combining therapeutics with mental health care delivery as addressing a significant unmet need in psychiatry. These developments reflect NRx’s ongoing efforts to enhance its product offerings and expand its market presence.
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