Pain Therapeutics, Inc. (NASDAQ: PTIE) is having an overwhelmingly rough start to the trading session in the pre-market hours this morning, and for good reason. The company announced that it has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA), surrounding its New Drug Application (NDA) for REMOXY. Unforutnatley, a CRL means that the treatment has been rejected. Today, we’ll talk about:
- The CRL;
- what we’re seeing from PTIE as a result; and
- what we’ll be watching for with regard to the stock ahead.
PTIE Announces Receipt Of A CRL
As mentioned above, Pain Therapeutics is having a rough start to the trading session this morning after announcing that it has received a CRL surrounding the NDA for REMOXY. REMOXY is an abuse-deterrent, extended-release form of oxycodone. However, according to the FDA, the data submitted in the NDA did not support the benefits PTIE submitted surrounding the treatment in the NDA. In a statement, Remi Barbier, President and CEO at PTIE, had the following to offer:
This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction… We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe REMOXY received an ideological judgement call that is vague in nature but conclusive in its damaging effects.
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 Pain Therapeutics, the news proved to be overwhelmingly negative. After all, this isn’t the first time the company has received a CRL surrounding REMOXY. So, it comes as no surprise that upset investors are sending the stock on a tear for the bottom. Of course, our partners at Trade Ideas were the first to alert us to the declines. Currently (8:28), PTIE is trading at $1.90 per share after a loss of $0.46 per share or 19.49% 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 PTIE. In particular, we’re interested in following the company’s moves following this devastating CRL receipt. Nonetheless, we’ll continue to follow the story closley and bring the news to you as it breaks!
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