Moleculin leaps as FDA grants three RPD designations for WP1066

Shares of USA-based Moleculin Biotech (Nasdaq: MBRX) shot up more than 33% to $1.04 yesterday, after in revealed that the US Food and Drug Administration has approved its request for a Rare Pediatric Disease (RPD) designation for its drug candidate WP1066.

The designation entitles Moleculin to receive a transferrable Priority Review Voucher (PRV) upon New Drug Approval (NDA) for each of three indications, including diffuse intrinsic pontine glioma (DIPG), medulloblastoma and atypical teratoid rhabdoid tumor.

"The early activity we are seeing in WP1066 is both unexpected and encouraging," commented Walter Klemp, chairman and chief executive of Moleculin, adding: "The approval of these three Rare Pediatric Disease designations is a reminder of just how important our efforts are to potentially help children with brain tumors."