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Acorda Files NDA for Parkinson's Disease Candidate Inbrija

Acorda Therapeutics, Inc. ACOR has submitted a new drug application (NDA) to FDA for its late stage pipeline candidate Inbrija (formerly known as CVT-301) for treatment of patients suffering from Parkinson’s disease. The company’s press release stated that the FDA has conditionally accepted its proposed trade name of Inbrija to market the drug on approval.

Notably, the NDA was submitted under section 505(b)(2) to FDA for the candidate. Based on current guidelines, the company expects the FDA response by September-end this year.

Inbrija is a self-administered inhaled levodopa (L-dopa) therapy for treating symptoms of OFF periods in people with Parkinson’s disease following an oral carbidopa / evodopa regimen.

However, shares of Acorda have underperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has increased 4% compared with the broader industry’s appreciation of 10%.

The NDA was submitted based on data from one phase III safety and efficacy study (SPAN-PD) and from two ongoing long-term safety studies (CVT-301-005 and CVT-301-004E) in people with Parkinson’s.

We remind investors that in Feb 2017, the company had collected positive data from the SPAN-PD study for the given indication. The phase III SPAN-PD study has met its primary endpoint of showing an improvement in motor function compared with placebo.

Additionally, in Mar 2017, Acorda had declared a positive interim data from both the ongoing long-term safety studies. Results from both these studies were consistent with previously reported data from the SPAN-PD phase III study.

Moving ahead, Acorda plans to file a marketing application in Europe by this year-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 people 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). Some top-ranked stocks in healthcare sector are VIVUS, Inc. VVUS, Bayer AG BAYRY and Regeneron Pharmaceuticals, Inc. REGN. While VIVUS and Regeneron sport a Zacks Rank #1 (Strong Buy), Bayer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates have shrunk from 50 cents to 39 cents for 2017 in the last 60 days. The company has delivered positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

Regeneron’s earnings per share estimates edged up from $10.17 to $10.52 for 2017 and from $10.90 to $12.10, over the last 60 days. The company has delivered positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%. Regeneron’s shares have surged 38.9% so far this year.

Bayer’s earnings per share estimates have improved from $8.36 to $8.85 for 2017 and from $8.88 to $9.52 for 2018, over the last 60 days. The company has delivered positive earnings surprises in three of the four trailing quarters with an average beat of 10.25%. Shares of Bayer have rallied 29.5% so far this year.

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