Acorda Therapeutics Inc (NASDAQ: ACOR) is having an overwhelmingly rough start to the trading session this morning, and for good reason. The company announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the company’s drug candidate. Of course, the news upset investors, sending the stock tumbling down. Today, we’ll talk about:
- The delay;
- what we’re seeing from ACOR in the market as a result; and
- what we’ll be watching for with regard to the stock ahead.
ACOR Announces Regulatory Delay
As mentioned above, Acorda Therapeutics is having a rough start to the trading session this morning after announcing a regulatory update. In a press release issued early this morning, the company said that the FDA has extended the PDUFA goal date for its review of the NDA of INBRIJA™ (levodopa inhalation powder) from October 5, 2018 to January 5, 2019.
ACOR said that the extension is the result of a response to an FDA request for additional information on chemistry, manufacturing and controls (CMC). In the release, the company said that the FDA has determined that these submissions constitute a major ammendment that will take time to review. In a statement, Ron Cohen, M.D., President and CEO at ACOR, had the following to offer:
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.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of Acorda Therapeutics, the news proved to be negative. After all, an extended review of a an NDA means that the potential approval of the treatment will be delayed at best. At worst, more data will be needed in order to approve the treatment. So, it comes as no surprise that upset investors are sending the stock tumbling. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (9:07), ACOR is trading at $16.15 per share after a loss of $2.35 per share or 12.70% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ACOR. In particular, we’re interested in following the story surrounding the INBRIJA NDA. While the PDUFA date has been extended, the treatment still has a chance of approval down the line. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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