Celgene Corporation (NASDAQ: CELG) is having an incredibly rough start to the trading session in the pre-market hours, and for good reason. The company announced a regulatory update, and the news was far from positive. Of course, this led to fear, sending the stock tumbling downward. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to CELG ahead.
CELG Gets Bad News From The FDA
As mentioned above, Celgene Corporation isn’t having a rough start to the trading session this morning after announcing news that it received from the FDA. In a press release issued early this morning, the company announced that it has received a Refusal to File letter from the United States Food and Drug Administration. The letter was with regard to the company’s New Drug Application (NDA) for ozanimod.
CELG is currently developing ozanimod for the treatment of patients with relapsing forms of multiple sclerosis. The treatment is an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator.
In the release, the company said that upon the FDA’s preliminary review, the regulatory agency found that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. In the release, the company said that it intends on seeking immediate guidance, including the request of a Type A meeting with the FDA, with the goal of getting a good understanding of the additional information required to submit the NDA. In a statement, Jay Backstrom, M.D., Chief Medical Officer and Head of Global Regulatory Affairs at CELG, had the following to offer:
We remain confident in ozanimod’s clinical profile demonstrated in the pivotal program in relapsing forms of multiple sclerosis… We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dabble in the market is that the news causes moves. In this particular case, the news surrounding Celgene was far from positive. Unfortunately, the company now needs to go back to the drawing board, figure out what mistakes they made, and correct those mistakes to even get the FDA to consider a complete review of the treatment. So, it’s no surprise to see that the stock is falling in the market today. Of course, our partners at Trade Ideas were the first to alert us to the declines. Currently (8:31), CELG is trading at $89.56 per share after a loss of $6.22 per share or 6.49% thus far today.
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 continue to keep a close eye on CELG. In particular, we’re interested in following the ongoing story surrounding ozanimod and we’ll be following the company’s progress on working to get the FDA to review the treatment. Nonetheless, we’ll continue to follow the story closely 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!