RedHill Biopharma Ltd. (RDHL) announced the FDA has granted rare pediatric disease designation to opaganib for treatment of neuroblastoma. The rare pediatric disease designation to opaganib provides for a Priority Review Voucher, subject to certain conditions.
Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
In pre-market trading on NasdaqCM, RedHill shares are down 21.57 percent to $0.80.
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