Akorn, Inc. (NASDAQ: AKRX) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced multiple FDA approvals over the Good Friday/Easter holiday break.
As you could imagine, the approvals led to excitement among investors who are pushing the stock on a run for the top. Today, we’ll talk about:
- The FDA approvals;
- what we’re seeing from AKRX stock as a result; and
- what we’ll be watching for ahead.
AKRX Announces Multiple FDA Approvals
As mentioned above, Akorn is having a strong start to the trading session this morning after announcing that it has received multiple approvals from the FDA. The news came by way of two separate press releases over the Good Friday/Easter holiday break.
In the first release, the company said that the United States FDA has approved its Abbreviated New Drug Application (ANDA) for Fluticasone Propionate Nasal Spray. The treatment has been approved as an option to provide patients with temporary relief from the symptoms of hay fever and other upper respiratory allergies in adult and pediatric patients ages 4 and older. In a statement, Douglas Boothe, President and CEO at AKRX, had the following to offer:
We are excited to add to our Fluticasone franchise and look forward to expanding into the over-the-counter (OTC) market. Among other private label possibilities, we have a supply agreement in place for Fluticare® through Innovus Pharmaceuticals, Inc. (OTCQB Venture Market: INNV).
In the second release, the company announced that it received yet another approval of an Abbreviated New Drug Application from the US FDA. This approval was in relation to the company’s generic Loteprednol Etabonate Opthalmic Suspension product. This is big news. According to IQVIA, US sales of Loteprednol Etabonate Opthalmic Suspension were approximately $89 million for the twelve months ended February 2019.
In a statement, Douglas Boothe, President and CEO at AKRX, had the following to offer:
This is a really exciting approval for Akorn as we believe it is a first generic approval for loteprednol suspension and it highlights our ability to execute on development and manufacturing of complex ophthalmic suspensions. I’m also pleased that we are in the final stages of preparing for commercial launch.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comest o Akorn, the news proved to be positive.
After all, with the approvals from the FDA, the company may now move forward with commercialization of these two products. This means that these products will likely lead to a meaningful increase in revenue.
Considering this, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:46), AKRX is trading at $3.09 per share after a gain of $0.32 per share or 11.56% 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 AKRX. In particular, we’re interested in following the story to see what kind of increase in revenue these two drug approvals bring. Nonetheless, we’ll continue to keep a close eye on the news and bring it to you as it breaks!
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