Our securities attorneys are investigating claims on behalf of investors of Acorda Therapeutics, Inc. (NASDAQ: ACOR) regarding possible violations of federal securities laws following the Food and Drug Administration’s refusal to review the company’s new drug application for Inbrija.
Share Price Plummets after FDA Deems NDA Incomplete
On August 29, 2017, Acorda announced that it had received a Refusal to File letter from the FDA regarding the company’s New Drug Application for Inbrija. Specifically, the FDA determined that the New Drug Application was not complete enough to permit a substantive review.
The FDA cited two specific issues:
- The date the manufacturing site would be ready for inspection
- A question regarding the submission of the drug master production record
The FDA has also requested further information at resubmission, which did not form the basis for the Refusal to File.
Following this news, Acorda share price plummeted by more than 24% to close at $19.45 on August 29, 2017.
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