Acorda Reports Death In Parkinson's Trials, Stock Down 40%

Acorda Therapeutics, Inc.'s (NASDAQ:ACOR) shares sank 40% on Wednesday after the company announced death of several patients in a late-stage study, evaluating one of its lead Parkinson’s disease (“PD”) candidates, tozadenant.

Shares of Acorda have underperformed the industry year to date. The stock has lost 9.6% compared to the industry’s increase of 0.2%.

Some patients in the phase III study were seen to have developed sepsis associated with agranulocytosis, a condition leading to the absence of white blood cells, which makes difficult to fight infection. The company suspects that the issue is possibly related to use of tozadenant. Also, cases of death were detected in the study.

Total of seven cases of sepsis were identified in the tozadenant groups including the previously conducted phase IIb study, of which, five were fatal. As a result, the company started monitoring blood cell count on a weekly basis.

The company said that it has halted enrollment in the long-term safety studies, which is part of the ongoing phase III program. Acorda expects to report the efficacy and safety data from the phase III study in the first quarter of 2018 after discussions with the independent Data Safety Monitoring Board and the FDA.

We remind investors that the company faced another setback in August when the FDA issued a refusal to file letter in connection with the new drug application (“NDA”) for another PD candidate, Inbrija.

The FDA has deemed the application incomplete after a preliminary review and therefore, the regulatory body now requires additional supporting information to review the application. The FDA’s refusal for Inbrija’s NDA will delay its commercial launch, previously expected in the first half of 2018. However, the company intends to file for an approval in Europe by the year-end.

Apart from Acorda, many companies are trying to introduce Parkinson’s disease treatments to the market namely, Prothena Corporation's (NASDAQ:PRTA) PRX002, AstraZeneca's (NYSE:AZN) MEDI1341, Prexton Therapeutics' Foliglurax and Prana Biotechnology's PBT434.

Also, Adamas Pharmaceuticals' (NASDAQ:ADMS) Gocovri has recently received an FDA approval for treating dyskinesia in patients with Parkinson’s disease. The company expects to make the drug available in the fourth quarter of 2017 and a formal launch is planned for January 2018.

With Parkinson’s market being the target area of many companies in the wake of recent approvals, the space is likely to get crowded in the near term. Hence, Acorda’s PD candidates my face an intense competition in the market once approved.

Zacks Rank

Acorda carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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