NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) shares slid as the Westlake Village, Calif.-based company a clinical-stage medical biotechnology concerm, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to perillyl alcohol (NEO100™) for the treatment of pediatric-type diffuse high-grade gliomas, a serious and life-threatening condition affecting children and adolescents.
The designation, issued under Section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), recognizes the urgent need for treatment options for pediatric-type diffuse high-grade gliomas. The FDA’s decision is based on findings that the disease primarily affects individuals from birth to 18 years and meets the statutory definition of a “rare disease or condition.”
“This designation marks a significant milestone in our efforts to develop innovative therapies for children battling this aggressive form of brain cancer,” said Amir Heshmatpour, Executive Chairman, NeOnc Technologies Holdings, Inc. “We remain committed to advancing NEO100 through clinical development to bring new hope to patients and families facing this devastating disease.”
The Rare Pediatric Disease Designation makes NeOnc Technologies eligible to receive a Rare Pediatric Disease Priority Review Voucher (PRV) upon approval of NEO100’s marketing application.
NTHI shares began Monday and the week down $3.78, or 22.8%, to $12.77.
