LOS ANGELES - ChromaDex Corp. (NASDAQ:CDXC) has received Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation from the U.S. Food & Drug Administration (FDA) for its investigational product NRC, aimed at treating Ataxia Telangiectasia (AT).
The company, a pioneer in nicotinamide adenine dinucleotide (NAD+) and healthy aging research is preparing to file an Investigational New Drug (IND) application to commence human clinical trials under the guidance of Dr. Vilhelm (Will) Bohr, a professor at the University of Copenhagen and a scientific advisor to ChromaDex.
AT is a rare, degenerative disease affecting children, characterized by neurological and immunological symptoms, with patients often becoming wheelchair-dependent. Currently, there is no cure or approved treatment for AT, which has a life expectancy of around 25 years for those diagnosed in childhood.
NRC has been previously studied in two peer-reviewed clinical trials, with findings indicating improved AT scores and immune function, as well as increased NAD+ levels and improved neuromotor coordination and eye movements in participants. These studies, which reported no serious adverse events, suggest that NRC is generally well-tolerated.
The ODD and RPD designations by the FDA are intended to encourage the development of treatments for rare diseases, offering benefits such as tax credits, fee waivers, and potential market exclusivity upon approval. Additionally, the RPD program includes a voucher system for expedited FDA review, applicable to drug approvals for rare pediatric diseases before September 30th, 2024.
ChromaDex's future clinical trials for NRC will be a significant step toward addressing the unmet medical needs of the AT community. Dr. Susan Perlman, MD, Clinical Professor of Neurology and Director of the Ataxia Center at the UCLA Medical Center, and a ChromaDex Clinical Consultant, expressed optimism about the upcoming trials and the potential relief they could bring to those affected by this debilitating disease.
This announcement is based on a press release statement from ChromaDex Corporation.
In other recent news, ChromaDex Corporation reported positive Q1 2024 financial results, with a revenue of $22.2 million and an adjusted EBITDA of $0.7 million. The company's e-commerce sector played a significant role in these results, showing a 5% increase in sales year over year. Additionally, ChromaDex announced strategic partnerships with Sprouts Farmers (NASDAQ:SFM) Market and Vitamin Shoppe, aiming to expand the distribution of its flagship product, Tru Niagen.
Despite an operating loss of $0.7 million, the company ended the quarter debt-free and with $27.6 million in cash. ChromaDex also disclosed plans for heavier investments in research and development during the first half of the year, with an expected revenue growth of at least 16% for the year.
The company's plans include exploring new partnerships and product launches, and the 1,000 milligram SKU of Tru Niagen is expected to contribute positively to revenue and retention rates.
InvestingPro Insights
In light of ChromaDex Corp.'s (NASDAQ:CDXC) recent advancements with their investigational product NRC, investors may find it valuable to consider some key financial metrics and expert insights. As the company prepares for clinical trials, the financial health and market performance of ChromaDex could play a crucial role in its ability to sustain research and development efforts.
An important highlight from the InvestingPro data is ChromaDex's market capitalization, which stands at $216.52 million. While the company's P/E ratio is currently negative at -60.85, reflecting investor speculation about future earnings rather than current profitability, this is not uncommon in the biotech industry where future potential is often the focus. Additionally, the company's revenue growth over the last twelve months was 7.52%, indicating a positive trajectory in its financial performance.
From the InvestingPro Tips, it is noteworthy that ChromaDex holds more cash than debt on its balance sheet, which is a reassuring sign of financial stability. This could be particularly advantageous as the company embarks on costly clinical trials. Furthermore, the stock has experienced a strong return over the last three months, with a 78.75% price total return, and an even more impressive 105.76% return over the last six months, showcasing significant investor confidence.
For those interested in deeper analysis, there are additional InvestingPro Tips available that can offer further insights into ChromaDex's financial health and market performance. With the exclusive coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these valuable tips.
It's also important to note that while ChromaDex does not pay a dividend, which is typical for growth-focused biotech companies, their liquid assets exceed short-term obligations, enhancing their financial resilience. As ChromaDex navigates the complex process of drug development and regulatory approval, these financial insights can help investors make informed decisions about the company's prospects.
For more detailed analysis and additional InvestingPro Tips, interested parties can visit InvestingPro's dedicated ChromaDex page at https://www.investing.com/pro/CDXC.
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