Acorda Therapeutics Inc. (NASDAQ: ACOR) saw its shares get crushed early on Tuesday after the firm received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for Inbrija.
Upon its preliminary review, FDA determined that the NDA, submitted back in June, was not sufficiently complete to permit a substantive review. The agency gave two reasons for the RTF. First was the date when the manufacturing site would be ready for inspection, And second was a question regarding the submission of the drug master production record.
The FDA also has requested additional information at resubmission, which was not part of the basis for the RTF.
Acorda is seeking immediate guidance, including a Type A meeting with the FDA, to respond to the issues.
For some quick background: Inbrija is an investigational treatment for symptoms of off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
Ron Cohen, M.D., Acorda’s president and CEO, commented:
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. We remain confident in INBRIJA’s data package and its promise as an important new therapy for people with Parkinson’s disease. We see tremendous long-term value in its solid clinical profile, significant commercial opportunity and strong IP, and we remain focused on working to bring patients this important new therapy.
The stock was down about 29% at $18.22 in early trading indications Tuesday. The consensus analyst price target was $23.86, and a 52-week trading range is $13.60 to $33.00.