Stock Alert: Stealth BioTherapeutics Soars 108%

(RTTNews) - Shares of Stealth BioTherapeutics Corp (MITO) more than doubled on Tuesday morning after FDA granted Rare Pediatric Disease (RPD) designation for the company's Barth syndrome drug.

The FDA granted Rare Pediatric Disease designation for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition. This condition is characterized by an enlarged and weakened heart, weakness in muscles used for movement, recurrent infections due to small numbers of white blood cell, and short stature.

Under the RPD designation program, the FDA may grant a priority review voucher to a sponsor who receives approval for a "rare pediatric disease," that primarily affects individuals aged from birth to 18 years and fewer than 200,000 people in the US.

CEO Reenie McCarthy said, "We hope to improve the healthspan of Barth patients, for whom cardiomyopathy, exercise intolerance and debilitating fatigue limit life expectancy and impair quality of life. We are also expanding our development efforts to consider trials in patients suffering from overlapping metabolic cardiomyopathies in diseases such as Duchenne and Becker muscular dystrophies, and Friedreich's ataxia."

MITO is currently trading at $3.96, up $2.06 or 108.421%, on the Nasdaq.