Acorda Therapeutics Inc. (NASDAQ: ACOR) shares dipped on Thursday after the company announced that the U.S. Food and Drug Administration (FDA) would be delaying its Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Inbrija.
The FDA is moving the PDUFA date back to January 5, 2019, from the previous date of October 5, 2018.
This extension is related to recent submissions Acorda made in response to requests from FDA for additional information on chemistry, manufacturing and controls. FDA determined that these submissions constitute a major amendment and will take additional time to review.
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Previously, the FDA accepted Acorda’s NDA for Inbrija in February 2018.
Ron Cohen, M.D., Acorda’s president and chief executive, commented:
We look forward to continuing our constructive dialogue with FDA. We remain committed to bringing INBRIJA to approval for people with Parkinson’s who experience OFF periods, which are highly disruptive and in need of new therapeutic options.
Excluding Thursday’s move, Acorda has underperformed the broad markets, with the stock down 20% in the past 52 weeks. In just 2018 alone, the stock is down closer to 14%.
Shares of Acorda were last seen down 12% at $16.30, with a consensus analyst price target of $27.00 and a 52-week range of $15.60 to $36.35.
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