RedHill Biopharma Ltd.
opaganib
neuroblastoma
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on opaganib for neuroblastoma is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 13h ago
“The FDA grant of rare pediatric disease designation to opaganib provides for a Priority Review Voucher (PRV), subject to certain conditions, and with opaganib's current neuroblastoma orphan drug designation also allows for the potential for”