RADNOR, Pa. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) has reported findings from a clinical trial suggesting that its investigational drug NRX-101 could be effective in reducing suicidality and akathisia in patients with bipolar depression.
The study compared NRX-101 with lurasidone, a current standard of care, and found a 33% advantage in sustained remission from suicidality and a 75% advantage in relief from akathisia, although these results were not statistically significant at the sample size of the phase 2 trial.
The trial, which was double-blind and randomized, showed that both NRX-101 and lurasidone resulted in approximately a 50% reduction in symptoms of depression. The findings are in line with the results of the company's previous STABIL-B trial and suggest a pathway for approval via a larger 300-person trial.
NRx Pharmaceuticals' Chairman and Chief Scientist, Prof. Jonathan Javitt, expressed optimism about the drug's potential, highlighting the need for treatments that decrease the risk of suicide in patients with bipolar depression. The reduction in akathisia, a side effect involving restlessness and agitation, was also noted as a significant outcome of the trial.
The drug's performance in this trial builds upon its designation by the FDA as a Breakthrough Therapy for treatment-resistant bipolar depression. The company plans to submit a New Drug Application for ketamine, which is used as an initial treatment for suicidal depression, by July 2024.
Moreover, NRx Pharmaceuticals is exploring the potential of NRX-101 as a primary treatment for the broader population of patients with bipolar depression who do not exhibit active suicidality.
This information is based on a press release statement from NRx Pharmaceuticals.
InvestingPro Insights
As NRx Pharmaceuticals (NASDAQ:NRXP) continues to advance its clinical trials, investors are closely watching the company's financial health and stock performance. According to InvestingPro data, NRXP has a market capitalization of approximately $37 million USD.
This relatively small market cap reflects the speculative nature of investing in biotech firms that are in the early stages of drug development. Notably, the company's P/E ratio stands at -0.91, indicating that it is not currently profitable, a common scenario for developmental-stage pharmaceutical companies.
The stock has experienced significant price volatility, with a 16.39% return over the last week, yet it has seen a -24.77% return over the past month. This high volatility is something investors should be mindful of, as it reflects the market's reaction to both the company's trial results and its financial position.
Moreover, the company's operating income, adjusted for the last twelve months as of Q4 2023, was reported at a loss of $27.59 million USD, underscoring the challenges faced by NRXP in achieving profitability.
Investors looking for further insights can explore additional InvestingPro Tips for NRXP, which include the company's rapid cash burn and the fact that short term obligations exceed liquid assets. These tips suggest caution for those considering an investment in NRXP, as the company may face liquidity challenges.
For a deeper analysis, including 9 additional tips that could help inform investment decisions, visit InvestingPro at https://www.investing.com/pro/NRXP. Don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing even more value for those seeking comprehensive financial insights.
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