Achaogen Inc (NASDAQ: AKAO) is having a relatively strong start to the trading session this morning, and it may just be the tip of the iceberg. That’s because today is the PDUFA date surrounding a New Drug Application submitted by the company, meaning that approval or rejection will take place today. Below, we’ll talk about:
- The NDA;
- what we’re seeing from AKAO; and
- what we’ll be watching for ahead.
AKAO PDUFA Date Is Today
As mentioned above, Achaogen is having a relatively strong start to the trading session this morning as the stock takes the spotlight with a PDUFA date today. PDUFA dates are dates on which the FDA will either approve or reject a new medication or medical device. For AKAO, that new medication is Plazomicin.
Months ago, the company submitted the NDA surrounding Plazomicin for two indications. The first and primary indication on the NDA was for the treatment of complicated urinary tract infections, or cUTI. The second indication was for the treatment of bloodstream infections. At this point, we’re pretty sure that the bloodstream infection indication will be rejected. After all, the advisory committee has voted to reject the treatment for this indication, wanting more data to support the safety of the treatment. However, the cUTI indication is likely to be the saving grace for AKAO.
While the advisory committee voted 11-to-4 to reject the treatment for bloodstream infections, the cUTI indication looks great. Not only did the data support the approval of the treatment, so too did the advisory committee. As a result, we believe that there is a strong chance that we will see an FDA approval for AKAO today.
What We’re Seeing From The Stock
With the PDUFA date being today and approval likely around the corner, excited investors are sending the stock on a run for the top. After all, if the drug is approved, chances are that the stock will see some pretty dramatic gains. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains on the stock this morning. At the moment (8:10), AKAO is trading at $12.80 per share after a gain of $0.38 per share (3.06%) 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 AKAO. In particular, we’re interested in following the story surrounding the company’s NDA with the FDA. Considering that today is the deadline for approval or rejection, we can expect to see a catalyst at some point today. Of course, we’ll continue to follow the story closely and bring the news to you as it breaks!
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