Alkermes Plc (NASDAQ: ALKS) is having an overwhelmingly strong start to the trading session this morning after announcing FDA news surrounding ALKS 5461. Of course, the news was positive, leading to an overwhelmingly positive reaction in the market. Today, we’ll talk about:
- The news surrounding ALKS 5461;
- what we’re seeing from the stock as a result;
- and what we’ll be watching for ahead.
ALKS Climbs On FDA News
As mentioned above, Alkermes is having an incredibly strong start to the trading session this morning after announcing news surrounding a key clinical candidate. In a press release issued early this morning, the company announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) surrounding ALKS 5461 for review. The treatment is a once-daily, oral medicine designed for the treatment of major depressive disorder. In the release, the company said that the FDA’s target action date surrounding the treatment is January 31, 2019. In a statement, Craig Hopkinson, M.D., CMO and SVP of Medicines Development and Medical Affairs at ALKS, had the following to offer:
FDA’s filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years….We will continue to engage with the FDA throughout the review process, as we work to 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 dig into the market is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive. After all, Alkermes now has an NDA in review with the FDA. If all goes well, the company will soon start generating revenue from product sales. So, it’s no surprise to see that the stock is making a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:08), ALKS is trading at $45.33 per share after a gain of $2.80 per share or 6.58% 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 efforts to bring ALKS 5461 to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!