Bullish indicating open at $55-$60, IPO prices at $37
Investing.com - BTIG raised its price target on NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to $21.00 from $18.00 while maintaining a Buy rating, citing progress with the FDA for its ketamine treatment for suicidal ideation. According to InvestingPro data, analyst targets for NRXP range from $18 to $46, with the stock currently trading at $2.52. The company’s shares have shown strong momentum with a 24.75% return over the past year, despite recent volatility.
The research firm highlighted that the FDA’s granting of Fast Track Designation represents acknowledgment that ketamine is a promising approach to treat suicidal thoughts and actions in depressed and bipolar patients. BTIG increased its probability of success for the program from 50% to 60%, reflecting that NRx now has the agency’s attention in an important indication. While InvestingPro analysis indicates the company currently operates with moderate debt levels and faces some liquidity challenges, analysts predict profitability this year.
NRx Pharmaceuticals is currently assembling patient-level data from three supportive trials into a conventional NDA package. These trials document the use of ketamine for suicidality in depressed bipolar patients, with data acquired by the company from previous studies.
The firm noted that while using clinical data from other sources is not the most common approval pathway, it has led to successful drug approvals since 2018 for conditions including Dravet’s syndrome and GBM. BTIG believes the mental health treatment community is interested in an FDA-approved version of ketamine.
NRx is advancing a preservative-free ketamine through both ANDA and NDA pathways, with the ANDA submission already complete. This could lead to approval for currently approved uses of ketamine, while the NDA would cover new indications including major depressive disorder, treatment-resistant depression, and suicidal ideation. With the company currently showing Fair Value potential and multiple catalysts ahead, investors can access comprehensive analysis and 8 additional key insights through InvestingPro’s detailed research report, part of its coverage of over 1,400 US stocks.
In other recent news, NRx Pharmaceuticals has been granted Fast Track designation by the U.S. Food and Drug Administration for its NRX-100 treatment, aimed at addressing suicidal ideation in patients with depression, including bipolar depression. This new designation significantly expands the potential patient population to approximately 13 million U.S. adults, a tenfold increase from the previous scope that only covered bipolar depression. In addition, HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, has received final approval from Florida’s Agency for Health Care Administration to acquire Dura Medical (TASE:BLWV) LLC, which offers various interventional psychiatry services.
Moreover, HOPE Therapeutics has signed a binding letter of intent to acquire a 49% interest in Cohen and Associates, a psychiatry clinic in western Florida, with expectations of immediate positive impacts on revenue and EBITDA. NRx Pharmaceuticals has also filed an Abbreviated New Drug Application with the FDA for a preservative-free intravenous ketamine formulation, NRX-100, aiming to address the ongoing U.S. ketamine shortage. This move seeks to replace existing ketamine formulations that contain benzethonium chloride, a preservative associated with neurotoxicity and cytotoxicity. These developments reflect NRx Pharmaceuticals’ strategic efforts to expand its market presence and address critical needs within the mental health treatment landscape.
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