Acorda Presents Phase III Data On PD Candidate CVT-301
Zacks Investment Research | Jun 07, 2017 05:42AM ET
Acorda Therapeutics, Inc. (NASDAQ:ACOR) presented data from a phase III study SPAN-PD, evaluating its late stage candidate CVT-301 (levodopa inhalation powder) at the International Congress of Parkinson’s Disease and Movement Disorders (MDS).
CVT-301 is being studied as a self-administered inhaled levodopa (L-dopa) therapy for treatment of symptoms of OFF periods patients suffering from Parkinson’s disease following an oral carbidopa / levodopa regimen.
Shares of Acorda have underperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has lost 18.6% compared to the broader industry’s gain of 1.7%.
In Feb 2017, the company has announced positive phase III clinical data on CVT-301 for the given indication. The phase III SPAN-PD study met its primary endpoint of showing improvement in motor function compared to placebo, as measured by the Unified Parkinson’s Disease Rating Scale – Part III (UPDRS III). Also, the multiple secondary endpoints were supportive of the primary endpoint result.
Along with data presented at the MDS Congress, Acorda announced positive interim information from an ongoing long-term safety study (CVT-301-005). In the trial, 271 participants with Parkinson's devoid of any asthma history or other chronic lung disease received CVT-301 84 mg up to five times daily, along with the usual Parkinson’s standard of care. Also, all ongoing participants completed their 36-week visit and 199 participants completed their 52-week visit.
Additionally, Acorda plans to file a New Drug Applicatiion (NDA) by the end of the second quarter of 2017 and file a Marketing Authorization Application (MAA) in Europe by 2017-end.
Per the company’s press release, around one million people in the U.S. and 1.2 million in Europe are diagnosed with Parkinson’s disease (PD). Among them, OFF periods are experienced by approximately 350,000 in the U.S. and 420,000 in Europe. Hence the market potential to address the unmet need is huge in this area.
Zacks Rank & Key Picks
Acorda currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector include VIVUS, Inc. (NASDAQ:VVUS) , Bayer (DE:BAYGN) AG (OTC:BAYRY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . While VIVUS sports a Zacks Rank #1 (Strong Buy), Bayer and Regeneron carry a Zacks Rank #2 (Buy). You can see .
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VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.
Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over last 60 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.
Bayer’s earnings per share estimates increased from $8.36 to $8.85 for 2017 and from $8.88 to $9.53 for 2018, over last 30 days. The company posted positive earnings surprises in three of four trailing quarters with average beat of 10.25%.
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