Y-mAbs neuroblastoma vaccine nabs accelerated review status in U.S.

The FDA designates Y-mAbs Therapeutics’ (NASDAQ:YMAB) GD2-GD3 Vaccine for neuroblastoma a Rare Pediatric Disease product.

Rare Pediatric Disease status provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.

The bivalent vaccine, in-licensed from MabVax Therapeutics Holdings (OTCPK:MBVXQ), is being evaluated in an escalating-dose Phase 1/2 clinical trial in high-risk patients. The estimated completion date is May 2020.

https://seekingalpha.com/news/3525846-y-mabs-therapeutics-neuroblastoma-vaccine-nabs-accelerated-review-status-in-u-s