RADNOR, Pa. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) revealed findings from its Phase 2b/3 trial of NRX-101, a potential treatment for bipolar depression with suicidal ideation, at the American Society of Clinical Psychopharmacology meeting in Miami Beach, FL. The trial compared NRX-101 to lurasidone, the current standard of care, and indicated that NRX-101 could reduce the time to sustained remission from suicidality by 58% and symptoms of akathisia by 76%.
These results came from a poster presentation titled "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior." The study showed that both treatments were effective in reducing depressive symptoms by over 50%. However, NRX-101 had a notably lower incidence of akathisia, a side effect linked to increased suicidal thoughts and actions, compared to lurasidone.
The company, based in Radnor, Pennsylvania, believes that these findings, along with earlier research, position NRX-101 as a potential new standard of care for the treatment of bipolar depression, which affects an estimated 7 million patients in the U.S. alone. This study marks the second clinical trial under FDA Good Clinical Practices guidelines to demonstrate substantial benefits of NRX-101 over lurasidone concerning akathisia and suicidality.
NRx Pharmaceuticals is developing NRX-101 for conditions such as suicidal bipolar depression, chronic pain, and PTSD. The drug has received a Breakthrough Therapy designation from the FDA for the treatment of suicidal bipolar depression resistant to treatment. The company is also working on a New Drug Application for HTX-100 (IV ketamine) through Hope Therapeutics for the treatment of suicidal depression.
The press release statement indicates that all currently approved antidepressant drugs have "black box" warnings from the FDA due to the potential increased risk of suicide. In contrast, NRX-101 has shown a statistically significant reduction in this risk. The company is preparing for a registration trial of NRX-101 vs. placebo to further evaluate its effectiveness in treating bipolar depression.
The information presented is based on a press release statement from NRx Pharmaceuticals, Inc. and has not been independently verified. Investors are advised to consider the inherent risks and uncertainties associated with such forward-looking statements.
InvestingPro Insights
As NRx Pharmaceuticals, Inc. (NRXP) advances its potential new standard of care for bipolar depression, the financial landscape of the company presents a mixed picture. With a market capitalization of $41.52 million, NRXP is navigating through challenging financial waters.
Notably, the company's P/E ratio stands at -1.25, indicating that investors are dealing with a company that is not currently profitable. This aligns with an InvestingPro Tip highlighting that analysts do not expect NRXP to be profitable this year, a sentiment echoed by the company's performance over the last twelve months.
Investors looking for stability may be concerned with another InvestingPro Tip pointing out that NRXP is quickly burning through cash, which could pose risks for its long-term operations. Moreover, the company's short-term obligations exceeding its liquid assets further emphasizes the importance of financial prudence and the necessity for NRXP to manage its capital efficiently.
Despite these financial challenges, NRXP has shown a strong price return over the last three months, with an impressive 29.59% increase. This could signal growing investor confidence in the company's clinical developments and future prospects. Additionally, the InvestingPro Fair Value estimate is at $4.91 USD, suggesting potential undervaluation at the current price of $3.95 USD.
For those interested in deeper financial analysis and additional insights, InvestingPro offers a comprehensive suite of tools and metrics. There are currently 7 additional InvestingPro Tips available for NRXP at https://www.investing.com/pro/NRXP, which could help investors make more informed decisions. Readers can also take advantage of a special offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to exclusive data and expert analysis.
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