Motif Bio Plc (NASDAQ: MTFB) is having an incredibly rough start to the trading session this morning, and for good reason. The company received a CRL, or Complete Response Letter, from the FDA. This letter outlined a rejection of a New Drug Application, upsetting investors and sending the stock tumbling. Today, we’ll talk about:
- The CRL;
- what we’re seeing from MTFB stock as a result; and
- what we’ll be watching for ahead.
MTFB Announces CRL Receipt
As mentioned above, Motif Bio is having a rough start to the trading session in the pre-market hours this morning after the company announced that it has received a CRL from the FDA.
In a press release issued early this morning, the company said that it received a CRL regarding the New Drug Application for iclaprim. The hope of the application was that icalprim would be approved as a treatment of acute bacterial skin and skin structure infections.
In the release, MTFB said that the CRL stated that the FDA is unable to approved the application in its present form. The letter also provided an indication that additional data are needed surrounding risk for liver toxicity before the treatment may be approved.
It is expected that the company will request a meeting with the FDA as soon as possible with a goal of addrssing options to remedy the deficiencies.
In a statement, Graham Lumsden, CEO at MTFB, had the following to offer:
We are disappointed for patients and providers seeking an alternative antibiotic to treat ABSSSI. We intend to request a meeting with the FDA, which typically should occur within approximately 30-45 days, to discuss the CRL. We look forward to working with the Agency to discuss options to advance iclaprim towards approval.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news leads to moves. For Motif Bio, the news proved to be overwhelmingly negative. After all, the Complete Response Letter means that at best, the company will have to sink more time and financial resources into the potential approval of the treatment. At worst, the treatment may never be approved due to potential toxicity issues. So, it’s not surprising to see that upset investors are sending the stock tumbling in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the declines. Currently (8:45), MTFB is trading at $2.43 per share after a loss of $7.64 per share or 75.87% 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 MTFB. In particular, we’re interested in following the story surrounding the company’s continued work to bring iclaprim to market. While the CRL is painful news, the company may still have a chance of approval down the line. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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