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
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