Lannett Company, Inc. (NYSE: LCI) is having a relatively strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that it has received approval of an Abbreviated New Drug Application from the FDA. Of course, FDA approval leads to excitement among investors in this space, and it’s doing just that. As a result, the stock is headed up. Today, we’ll talk about:
- The approval;
- what we’re seeing from the stock;
- and what we’ll be watching for with regard to LCI ahead.
LCI Announces FDA Approval
As mentioned above, Lannett Company is having an incredibly strong start to the trading session this morning after the company announced that it has received approval from the United States Food and Drug Administration (FDA). The approval surrounds the Abbreviated New Drug Application, or ANDA, for Levofloxacin Oral Solution USP. The 25mg/mL treatment is a therapeutic equivalent to the reference listed drug, Levaquin® Oral Solution, 25 mg/mL, which is developed and manufactured by Jannsen Pharmaceuticals for 12 months. In the release, LCI said that in the 12 months ended April, 2018, total US sales of Levofloxacin came to approximately $6 million. In a statement, Tim Crew, CEO at LCI, had the following to offer:
Our ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved three weeks ahead of the Target Action Date… While the commercial opportunity for our Levofloxacin product is modest, the expected near-term launch is further evidence of our growing operational effectiveness. We continue to make progress unlocking the value of our many approved products pending launch and expect to announce additional product launches in the coming months.
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 this particular case, the news proved to be overwhelmingly positive. After all, FDA approval opens the door to revenue generating opportunities. So, it’s no surprise that the Lannett Company is headed up in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:50), LCI is trading at $17.00 per share after a gain of $0.45 per share or 2.72% 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 LCI. In particular, we’re interested in following the story surrounding Levovloxacin and the revenue generated through the product, now that it is fully approved. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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