Parkinson's drug setback hits Acorda stock hard
More than 24% was taken off the market value of neurological disorders specialist Acorda Therapeutics (Nasdaq: ACOR) on Tuesday after the company received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Inbrija (levodopa inhalation powder).
Inbrija is an investigational treatment for symptoms of ‘off’ periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
The FDA ruled that Acorda’s NDA was not sufficiently complete to permit a substantive review, saying that the company had failed to state when the manufacturing site would be ready for inspection. The agency also raised a question regarding the submission of the drug master production record, and has asked for additional information at resubmission, which was not part of the basis for the RTF.
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