Acorda Therapeutics Inc (NASDAQ: ACOR) is having an overwhelmingly rough start to the day in the pre-market hours today, and for good reason. The company received upsetting news from the FDA that’s leading to fear among investors who are sending the stock down dramatically. Of course, our partners at Trade Ideas were the first to alert us to the losses. At the moment (8:23), ACOR is trading at $17.75 per share after a loss of $7.95 per share or 30.93% thus far today.
ACOR Announces Refusal To File Letter From The FDA
As mentioned above, Acorda Therapeutics is having a rough day in the market this morning after announcing that it has received a Refusal to File letter from the United States Food and Drug Administration. The letter was associated with the New Drug Application the company attempted to file surrounding INBRIJA, an investigational treatment for symptoms of OFF periods in patients with Parkinson’s disease that are on the carbidopa/levo-dopa regimen.
In their letter, the FDA informed the company that upon preliminary review, it determined that the NDA that was submitted on June 26, 2017 was no sufficiently complete to permit a substantive review. In particular, the date when the manufacturing site would be ready for inspection was an issue. Also, there were questions regarding the submission of the drug master production record. As a result, the FDA asked for further information upon resubmission. In a statement, Ron Cohen, M.D., President and CEO at ACOR, had the following to offer…
“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… We remain confident that INBRIJA’s data package and its promise as an important new therapy for people with Parkinson’s disease. We see tremendous long-term value in it’s solid clinical profile, significant commercial opportunity and strong IP, and we remain focused on working to bring patients this important new therapy.”
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on ACOR. In particular, we’re interested in following the ongoing work surrounding INBRIJA and the goal of resubmitting the NDA surrounding the treatment. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!