Acorda Therapeutics Inc. (NASDAQ:ACOR) saw its shares plunge by around 30% in pre-market trading after the company revealed it has received a ‘Refusal to File’ letter from the US Food and Drug Administration regarding its new drug application (NDA) for an investigational treatment for symptoms of Parkinson's disease.
The FDA said Acorda’s NDA for the Inbrija treatment was not complete enough to permit a substantive review.
Specifically, the group said the FDA questioned the date by which the manufacturing site would be ready for inspection, as well as the submission of the drug master production record.
The NASDAQ-listed company said in its statement that it will seek a meeting with the FDA and that it believes the issues can be addressed.
Acorda’s chief executive, Ron Cohen said: "We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application."
He added: "We remain confident in INBRIJA's data package and its promise as an important new therapy for people with Parkinson's disease."
In pre-market New York trading, Acorda shares were down 30.4% to US$17.90.
In the regular session, shares plunged almost 27% to $18.78 each.