01.10.2019 14:35:17
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Catabasis Pharma's Phase 3 DMD Trial Exceeds Target Enrollment; Stock Up 5%
(RTTNews) - Shares of Catabasis Pharmaceuticals Inc. (CATB) are up over 5% in premarket trading on Tuesday, following the completion of enrollment in the Company's phase III trial of Edasalonexent in Duchenne muscular dystrophy.
The study, dubbed PolarisDMD, has exceeded the target enrollment of 125 boys, and has enrolled 130 boys ages 4 to 7 with any mutation type and who had not been on steroids for the past 6 months.
The Company expects to report top-line results from the phase III PolarisDMD trial in the fourth quarter of 2020, with NDA filing for Edasalonexent anticipated in 2021.
Duchenne Muscular Dystrophy, or DMD in short, is a rare genetic muscle-wasting disease caused by the absence of dystrophin, a protein necessary for muscle function. DMD usually affects boys, and its prevalence is roughly 1 in 3,500 boys worldwide.
PTC Therapeutics' Emflaza and Sarepta Therapeutics' Exondys 51 are the two FDA-approved drugs for DMD.
CATB closed Monday's trading at $5.40, up 1.89%. In Tuesday's premarket trading, the stock is up 5.56% at $5.70.
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