FDA Approves Rare Pediatric Disease Designations for WP1066

Moleculin Biotech announced the US Food and Drug Administration (FDA) has approved its request for a "Rare Pediatric Disease" 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. 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,” Walter Klemp, Chairman and CEO of Moleculin said. "It is also important for investors to understand the implications of the PRVs or Priority Review Vouchers. These vouchers are issued upon drug approval of the rare disease indication from the FDA and, once issued, can be transferred to other drug developers. These PRVs have historically had tremendous value and have been recently sold for up to $100 million or more. For Moleculin to have the potential for three of them is noteworthy indeed."