NeOnc Technologies Holdings (NTHI) said Monday that the US Food and Drug Administration has granted rare pediatric disease designation to perillyl alcohol, also known as NEO100, for the treatment of pediatric-type diffuse high-grade gliomas.
The company said the FDA designation was based on findings that pediatric-type diffuse high-grade gliomas meets the statutory definition of a rare disease or condition.
According to NeOnc Technologies, the designation makes it eligible to receive a priority review voucher upon approval of the marketing application for perillyl alcohol. The program is meant to encourage development of new treatments for rare pediatric diseases by providing an expedited regulatory review process.
Shares of NeOnc Technologies Holdings were down more than 24% in recent Monday trading.
Price: 12.00, Change: -5.00, Percent Change: -29.41
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.