Acorda Gets Refusal To File Letter From FDA For INBRIJA NDA; Stock Plunges

(RTTNews) - Acorda Therapeutics Inc. (ACOR) said Tuesday that it received a Refusal to File or RTF letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen.

In the pre-market trade, ACOR is trading at $17.95, down $7.75 or 30.16 percent.

Upon its preliminary review, FDA determined that the NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review. FDA specified two reasons for the RTF: first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission, which was not part of the basis for the RTF.

The Company said it will seek immediate guidance, including a Type A meeting with the FDA, to respond to the issues, which it believes are addressable, and to seek clarification of what additional information will be required. The FDA has not requested or recommended additional clinical efficacy or safety studies.