ADMA Biologics Inc (NASDAQ: ADMA) is screaming for the top early on in the market this morning, and for good reason. The company announced a PDUFA date, which is a date when the United States Food and Drug Administration (FDA) will either approve or reject a treatment. Today, we’ll talk about:
- The announcement;
- what we’re seeing from AMDA as a result; and
- what we’ll be watching for ahead.
AMDA Climbs On PDUFA Date Announcement
As mentioned above, ADMA Biologics is having an incredibly strong start to the trading session this morning after the company announced news surrounding the potential regulatory approval of a new treatment. In a press release issued early this morning, the company announced that the United States FDA has acknowledged the receipt of the company’s PAS filing for review, seeking to amend the FDA approved BLA for BIVIGAM® (Intravenous Immune Globulin [Human], 10%) (“IVIG”). If the PAS is approved, the company intends to relaunch BIVIGAM in the United States.
In the release, ADMA said that the PDUFA target action date for the PAS is October 25, 2018. The PDUFA date is a date under the Prescription Drug User Fee Act that gives the FDA a deadline with regard to the approval or rejection of a new or amended treatment. In a statement, Adam Grossman, President and CEO at ADMA, had the following to offer:
Since the acquisition of the Biotest Therapy Business Unit, (“BTBU”) assets in June 2017, ADMA has been working diligently to address open quality, compliance and production issues which have affected the facility since 2014. The FDA’s forthcoming review of the PAS filing for BIVIGAM® has been a significant corporate priority for ADMA, and we are pleased to announce the achievement of this important milestone.
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 causes moves. When it comes to ADMA Biologics, the news released today was overwhelmingly positive. After all, in just a few months, we could see a product launch in the United States. So, it’s no surprise that excited investors are sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:11), ADMA is trading at $6.02 per share after a gain of $1.08 per share or 21.90% 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 ADMA. In particular, we’re interested in following the story surrounding the PSA and whether or not it is approved in just a short few months. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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