Fibrocell Science Inc (NASDAQ: FCSC) is off to an incredibly strong start in the pre-market hours this morning, and for good reason. The company announced receipt of Rare Pediatric Disease Designation by the FDA. Of course, this caused excitement among investors, leading to gains in the stock and an alert from our partners at Trade Ideas. At the moment (8:32), FCSC is trading at $2.71 per share after a gain of $0.23 per share or 9.27% thus far today.
FCSC Gains On Rare Pediatric Disease Designation
As mentioned above Fibrocell Science is off to a strong day in the market today after announcing that the United States Food and Drug Administration has granted Rare Pediatric Disease Designation to FCX-013. FCX-013 is the company’s gene therapy candidate for the treatment of moderate to severe localized scleroderma. The Rare Pediatric Disease Designation augments the Orphan Drug Designation the company has already received surrounding the treatment. In a statement, John Maslowski, CEO at FCSC, had the following to offer…
“We are pleased the FDA has awarded Rare Pediatric Disease Designation to FCX-013, which in addition to its Orphan Drug Designation provides important incentives to Fibrocell for developing therapies for rare pediatric deseases… Moderate to severe forms of localized scleroderma, including the liner subtype, can result in significant morbidity, including pain, restricted motion, disfigurement and developmental issues. With no FDA-approved therapies available, we believe controlled gene therapy through FCX-013 offers promise to address this high unmet medical need of patients suffering from this chronic and often debilitating disease.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on FCSC. In particular, we’re interested in following the company through it’s ongoing work surrounding FCX-013. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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