FDA aligns with NRx on pediatric depression drug study
RADNOR, Pa. – NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage pharmaceutical company, today announced an agreement with the U.S. Food and Drug Administration (FDA) on an initial Pediatric Study Plan (iPSP) for NRX-100, a treatment for suicidal depression in adolescents aged 9-17.
This alignment is a critical step before filing a New Drug Application (NDA) for NRX-100, anticipated in the Q4 (2024), with a Prescription Drug User Fee Act (PDUFA) goal date in the second quarter of 2025.
The FDA’s feedback underscores the growing concern over adolescent suicide rates in the United States. According to the Centers for Disease Control (CDC), 10% of high school students attempted suicide in the past year, with higher rates among specific demographics.
Prof. Jonathan Javitt, Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics, expressed gratitude for the FDA’s recognition of the critical need for treatments targeting suicidal depression in youth. Following the FDA’s guidance, NRx and HOPE Therapeutics will conduct a clinical trial of NRX-100 in the specified adolescent age group. However, studies in younger children will not be required after initial adult approval.
The company also outlined potential revenue streams and paths to profitability by 2025, including revenue from the operation of HOPE Therapeutics-branded clinics and sales of NRX-100 and NRX-101, pending FDA approval. NRx Pharmaceuticals is in partnership with Alvogen and Lotus for the development and marketing of NRX-101 for suicidal bipolar depression.
In financial developments, NRx Pharmaceuticals reported a reduction in net loss from operations by 41% year-over-year during their first quarter 2024 earnings call and improved its access to working capital by $8 million. The company is also preparing to file new drug applications for NRX-101 in bipolar depression and HTX-100 for suicidal depression.
InvestingPro Insights
As NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) forges ahead with its plans for NRX-100, a treatment for suicidal depression in adolescents, it’s important for investors to consider the company’s financial health and market performance. According to InvestingPro data, NRXP currently has a market capitalization of 25.85 million USD, reflecting the market’s current valuation of the company.
InvestingPro Tips reveal that NRXP is quickly burning through cash and suffers from weak gross profit margins. These factors are critical for investors to consider, especially as the company prepares for an NDA filing and subsequent clinical trials, which are capital-intensive activities. Additionally, the company’s short-term obligations exceed its liquid assets, which could pose challenges in managing its cash flow effectively in the near future.
Furthermore, analysts do not anticipate NRXP to be profitable this year, and the company has not been profitable over the last twelve months as of Q1 2023. This aligns with the adjusted P/E ratio of -1.06, indicating that the company is currently not generating earnings per share that would justify its stock price based on traditional valuation metrics.
Despite these financial challenges, the company’s focus on addressing a significant public health issue may offer long-term growth potential if its treatments can successfully navigate the regulatory pathway and demonstrate efficacy and safety in the targeted patient populations.
For those interested in a deeper dive into NRXP’s financials and additional insights, there are 6 more InvestingPro Tips available at https://www.investing.com/pro/NRXP. Don’t forget to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, offering valuable analytics to inform your investment decisions.
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