As of 10:47 a.m. EST Thursday, shares of specialty pharmaceutical company Acorda Therapeutics (NASDAQ:ACOR) were up by more than 15%. The drugmaker's stock is moving higher this morning in response to the news that its inhaled Parkinson's disease drug, CVT-301, hit the mark in a late-stage trial.
According to the press release, patients receiving CVT-301 exhibited a statistically significant improvement in motor function when experiencing off periods (when the symptoms of Parkinson's disease re-emerge) compared to those taking a placebo. Acorda also noted that no notable pulmonary safety signals were detected in the study, which is always a concern with drugs delivered via the respiratory system.
The company reportedly plans on filing for the drug's approval with the Food and Drug Administration in the second quarter of 2017, depending on the results of CVT-301's ongoing long-term safety studies.
With its multiple sclerosis drug Ampyra nearing its commercial peak, Acorda could certainly use a second major source of revenue, and CVT-301 seems to have the juice to be able to do that if approved. The drug's peak sales, after all, have been estimated to be as high as $500 million, making it an important value driver to keep tabs on moving forward.
Apart from proving a new source of top-line growth, CVT-301 could provide the company with some much-needed diversification. Because of the pending legal challenges to Ampyra's core patent portfolio, investors have steered clear of this specialty pharma stock over the past year, with its shares sporting a mind-boggling price-to-sales ratio of just 2. So a regulatory approval for CVT-301 would obviously go a long way toward lowering Acorda's hefty risk profile. Until then, however, I'm content to watch these pivotal events from the sidelines.