Alkermes Plc (NASDAQ: ALKS) isn’t having the best of starts to today’s trading session, and for good reason. The company announced the results of an Advisory Committee vote, and those results were anything but positive. Of course, the news upset investors who are sending the stock tumbling down in the market this morning. Today, we’ll talk about:
- The FDA news;
- what we’re seeing from the stock as a result; and
- what we’ll be watching for with regard to ALKS ahead.
ALKS Falls On Advisory Committee Vote
As mentioned above, Alkermes is having a rough start to the trading session this morning after announcing the results of yesterday’s dual advisory committee meeting. Yesterday, the company met with the FDA and its Psychopharmacologic Drugs Advisory Committee as well as the Drug Safety and Risk Management Advisory Committee. During the meeting, the partiers discussed the New Drug Application for ALKS 5461.
Unfortunately, the two committees jointly voted against the approval of the treatment. All in all, the treatment received 2 yes votes and 21 no votes. It’s worth mentioning that advisory committee votes are not the end all be all, but they are very important. After all, it’s rare that with such a negative advisory committee vote, a treatment would be approved.
In a statement, Richard Pops, CEO at ALKS, had the following to offer:
We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants… We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In the case of Alkermes, the news proved to be negative. After all, the poor advisory committee vote means that the company’s treatment isn’t likely to be approved, at least this time around. So, it comes as no surprise that upset investors are sending the stock tumbling. As is just about always the case, our partners at Trade Ideas were the first to alert us to the declines. At the moment (8:48), ALKS is trading at $37.61 per share after a loss of $3.22 per share or 7.89% 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 ALKS. In particular, we’re interested in following the story surrounding the company’s continued work to bring ALKS 5461 to market, although chances may be slim at the moment. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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