In response to an announcement of a delay in the regulatory review process for a key pipeline compound, shares of Acorda Therapeutics (NASDAQ:ACOR), a biopharmaceutical company focused on neurological disorders, fell 12% as of 10:38 a.m. EDT on Thursday.
Acorda announced today that the PDUFA date for its experimental Parkinson's pipeline compound Inbrija has been delayed by three months. The FDA now expects to hand down a go/no-go decision on Jan. 5, 2019. That's about ninety days later than its previously announced target date of Oct. 5, 2018.
The FDA decided to delay the drug's PDUFA date because Acorda recently submitted additional data to the agency related to Inbrija's chemistry, manufacturing, and controls. Since this data qualifies as a major amendment, the agency stated that it needed additional time to make a decision.
Traders knocked down the company's share price in response to the updated timeline.
It's been a rough week for Acorda's shareholders. On Monday Acorda's shares were whacked in response to an unfavorable court ruling that threatens the company's top-selling multiple sclerosis drug, Ampyra. The floodgates are now open for generic competition to enter the market, so Acorda Therapeutics' revenue looks poised to tumble. That amps up the pressure on the company to turn Inbrija into a commercial success, so today's news is certainly troubling.
Overall, I'm rooting for Inbrija's success, but with sales of Ampyra poised to fall, Acorda has turned into an extremely risky business. For that reason, I'm content to look elsewhere for more promising healthcare stocks.