Catabasis Hits 52-Week Low on Poor DMD Drug Study Data

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Cambridge, MA-based Catabasis Pharmaceuticals, Inc. 's CATB shares tumbled to a new 52-week low of $1.08 on Feb 1 after the company announced disappointing top-line safety and efficacy data from part B of the MoveDMD study (phase I/II) on edasalonexent (CAT-1004).

The company's shares closed a little higher at $1.18, reflecting a decline of almost 71% from the close of the previous trading session.

A look at Catabasis' share price movement over the past one year shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, Catabasis' stock dropped 81% during this period, while the industry lost 6.2%.

Coming back to the latest news, edasalonexent, a molecule that inhibits a protein called NF-kB is being developed for the treatment of patients with Duchenne muscular dystrophy (DMD).

The randomized, double-blind, placebo-controlled study evaluated ambulatory boys (n=31) aged between 4 and 7 years with a genetically confirmed diagnosis of DMD across a range of dystrophin mutations.

Results revealed that patients receiving edasalonexent (67 mg/kg/day and 100 mg/kg/day) failed to result in significant improvement in lower leg muscle inflammation, compared to those on placebo, after 12 weeks, thereby missing the primary efficacy end point of the study.

However, there was no treatment-related serious adverse event, no drug discontinuation and no dose reduction.

Catabasis plans to complete a full analysis of the data and submit the same for presentation at a future scientific conference.

Meanwhile, the company is evaluating edasalonexent in part C of the MoveDMD study (open-label extension portion). Interim data from the part C study are expected in the second quarter of 2017 and full results in 2017.

In the U.S., 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.

DMD, a devastating and debilitating disease, represents a market with significant unmet medical need. Currently, Sarepta Therapeutics Inc.'s SRPT Exondys 51 is the only approved DMD drug to treat a specific genetically defined group of patients.

We remind investors that in Sep 2016, Catabasis entered into a research partnership with Sarepta to explore a combination of edasalonexent and Exondys 51 for the treatment of DMD.

The unfavorable part B data from the MoveDMD study is a major setback for Catabasis. Note that the company is highly dependent on edasalonexent for growth.

Going ahead, we expect investor focus to remain on further details pertaining to the part C of the MoveDMD study and full analysis of data from the part B of the study.

Catabasis Pharmaceuticals, Inc. Price and Consensus

Catabasis Pharmaceuticals, Inc. Price and Consensus | Catabasis Pharmaceuticals, Inc. Quote

Zacks Rank & Key Picks

Catabasis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP and Anika Therapeutics Inc. ANIK . While Sucampo sports a Zacks Rank #1 (Strong Buy), Anika is a Zacks Rank #2 (Buy) stock. You can see the complete list of today's Zacks #1 Rank stocks here .

Sunesis' loss estimates for 2017 are down 8.80%, while that for Anika's earnings are up 0.5% over the last 60 days. Both the companies recorded a positive earnings surprise in each of the last four quarters, the average being 35.33% and 33.14%, respectively.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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