BRIEF—ArQule awarded rare pediatric disease designation for miransertib

East Coast rare disease and oncology specialist ArQule has picked up rare pediatric disease designation for its Proteus syndrome candidate miransertib (ARQ 092).

The decision means the company may now be eligible to receive a priority review voucher for future use, if the drug is approved in this indication.

In pre-market trading on the Nasdaq, the company’s share price is up 15%.

ArQule is enrolling a Phase I/II trial for overgrowth diseases, including Proteus syndrome, driven by either the AKT or PI3K mutation. Miransertib is an inhibitor of the AKT kinase.