Fibrocell up on Castle Creek collaboration

Nano cap Fibrocell Science (NASDAQ:FCSC) is up 51% premarket on robust volume in response to its collaboration with Castle Creek Pharmaceuticals to develop and commercialize gene therapy candidate FCX-007 for recessive dystrophic epidermolysis bullosa, a rare inherited disorder characterized by fragile blistering skin.

Under the terms of the deal, Castle Creek will have an exclusive license to commercialize FCX-007 in the U.S. and will be responsible for all development and manufacturing costs up to $20M prior to the filing of a marketing application. If development spending exceeds $20M, Fibrocell will cover 30% of the excess expenses. Castle Creek will be responsible for all commercialization activities and costs while Fibrocell will maintain clinical development, regulatory interactions and manufacturing under a future supply agreement with Castle Creek.

Fibrocell will receive $7.5M upfront, $2.5M when the first patient is enrolled in a Phase 3 study, $30M when the FDA approves the marketing application and market launch is ready, up to $75M in sales-based milestones, an additional $50M if sales reach $750M and 30% of gross profits.

Fibrocell will retain sole ownership of the Rare Pediatric Disease Priority Review Voucher that it will receive on the FDA nod for FCX-007.

A Phase 3 clinical trial, DEFI-RDEB, should launch this quarter.

https://seekingalpha.com/news/3450615-fibrocell-51-percent-premarket-castle-creek-collaboration