Catabasis Pharmaceuticals, Inc. (CATB - Free Report) announced data from a phase II study, which showed that its pipeline candidate, edasalonexent substantially slowed disease progression, in male children with Duchenne muscular dystrophy ("DMD"). The company is planning to initiate a phase III study on the candidate in the first half of 2018.
Catabasis’ stock closed more than 7% higher on Wednesday following the news. However, shares of the company are down 16.1% so far this year, underperforming the industry which is up 14.6% in that period.
Data from the phase II MoveDMD study showed that edasalonexent improved the rates of decline in timed function tests by clinically meaningful numbers compared to control period. The control period correspond to the period prior to administration of edasalonexent, either prior to Phase 2 or in the placebo group, for an average period of 39 weeks. A dose of 100 mg/kg/day was administered for a maximum of 36 weeks in child patients aged four to seven years.
The candidate also significantly reduced the level of four muscle enzymes from baseline which suppress muscle regeneration and deteriorate muscle integrity.
Based on these positive data from the study, Catabasis is planning to advance the candidate to phase III by June 2018. The study will observe the patients over a period of 12 months and top-line data is expected in 2020.
In the United States, edasalonexent enjoys Orphan Drug, Fast Track and Rare Pediatric Disease designations for the treatment of DMD. In the EU, the candidate enjoys Orphan Medicinal Product designation for this indication.
We remind investors that Sarepta Therapeutics, Inc.’s (SRPT - Free Report) Exondys 51 and PTC Therapeutics, Inc.’s (PTCT - Free Report) Emflaza are the only two approved therapies for DMD in the United States. Catabasis has a research partnership with Sarepta to explore a combination of edasalonexent and Exondys 51 for the treatment of DMD.
Zacks Rank & Key Pick
Catabasis carries a Zacks Rank #2 (Buy). Biogen Inc. (BIIB - Free Report) is another stock worth considering in the health care sector, also carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biogen’s earnings per share estimates have moved up from $21.37 to $21.42 for 2017 and from $23.11 to $23.23 for 2018 over the last 30 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 6.41%. The share price of the company has increased 11% year to date.
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