Acorda Therapeutics (ACOR) was turned away at the FDA’s doorstep when it tried to submit a marketing application for a new drug to treat Parkinson’s disease. The embarrassing regulatory miscue disclosed Tuesday will delay the drug’s approval.
Shares of Acorda fell 27 percent to $18.75 in Tuesday pre-market trading.
The FDA issued a so-called Refuse to File letter regarding the new drug application for Inbrija, an inhaled formulation of the Parkinson’s drug levodopa aimed at reducing involuntary muscle movements in Parkinson’s patients during the “off” periods when their standard medicines stop working.
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