Acorda Therapeutics Inc. shares slid 24% premarket Tuesday, after the company said it has received a Refusal to File letter from the U.S. Food and Drug Administration regarding its new drug application for inbrija, an investigational treatment for symptoms of Parkinson’s disease. The FDA said the NDA was not complete enough to permit a substantive review. Specifically, it questioned the date by which the manufacturing site would be ready for inspection, as well as the submission of the drug master production record. The company said it will seek a meeting with the FDA and that it believes the issues can be addressed. “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,” Chief Executive Ron Cohen said in a statement. “We remain confident in INBRIJA’s data package and its promise as an important new therapy for people with Parkinson’s disease.” Shares have gained 37% in 2017, while the S&P 500 has gained 9%.
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