Motif Bio Plc (NASDAQ: MTFB) is flying early on in the market this morning, and for good reason. The comapny announced FDA news, exciting investors and sending the stock for the top. Today, we’ll talk about:
- The FDA news;
- what we’re seeing from MTFB stock as a result; and
- what we’ll be watching for ahead.
MTFB Stock Gains On FDA News
As mentioned above, Motif Bio is having an incredibly strong day in the market today after announcing FDA news. The news came via press release early this morning.
In the release, the company announced that the United States Food and Drug Administration has granted a request. Previously, MTFB requested a Type A meeting with the FDA in order to discuss the points raised in a recent Complete Response Letter.
The CRL was related to the New Drug Application for iclaprim, a treatment under development for acute bacterial skin and skin structure infections. In the release, the company said that the meeting is scheduled to take place on May 3, 2019.
In a statement, Graham Lumsden, CEO at MTFB, had the following to offer:
We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts. We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval.
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 leads to moves. In the case of Motif Bio, the news proved to be overwhelmingly positive.
After all, the Type A meeting could result in a pathway for potential regulatory approval. Should this happen, the treatment may hit the market in the United States relatively soon.
So, it’s not surprising to see that excited investors are sending 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 (10:00), MTFB is trading at $3.26 per share after a gain of $1.65 per share or 102.48%.
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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 MTFB. In particular, we’re interested in following the story surrounding the Type A meeting with the FDA and the company’s continued work to bring iclaprim to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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