NEW YORK (TheStreet) -- Fibrocell Science (FCSC) shares are up 19.7% to $4.26 in afternoon trading on Wednesday after the biompharmaceutical company announced that the Food and Drug Administration granted rare pediatric disease designation for its experimental recessive dystrophic epidermolysis bullosa (RDEB) treatment candidate FCX-007.
The FDA defines a rare pediatric disease as an affliction that affects fewer than 200,000 people under the age of 18. Treatments given the rare pediatric disease priority designation receive a priority new drug application review.
RDEB is the most severe form of dystrophic epidermolysis bullosa that causes debilitating pain and can potentially be fatal.
"We are pleased that the FDA has granted our request to designate FCX-007 for the treatment of RDEB as a drug for a rare pediatric disease. FCX-007 may offer RDEB patients and their families the first therapy to treat the underlying cause of the disease, bringing hope and relief to what is today a painful, disabling and often fatal congenital disorder," said CEO David Pernock.
"We are also pleased that the incentives offered by both the Orphan Drug and rare pediatric disease designations-including the potential to obtain a valuable Rare Pediatric Disease Priority Review Voucher from the FDA-could provide additional ways to create value for our shareholders," Pernock continued.FCSC data by YCharts
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