Pain Therapeutics, Inc. (NASDAQ: PTIE) is halted early on in the trading session this morning. The halt is a T1 halt, which means that the stock is not trading, as material news is set to be released. Chances are that the release will happen at some point today. While NASDAQ does not tell you what material news is coming, we believe that we’ve figured that out. Today, we’ll talk about:
- The halt;
- the news; and
- what we’ll be watching for with regard to PTIE ahead.
PTIE Halted With News Pending
As mentioned above, Pain Therapeutics is halted early on in the pre-market hours. The code for the halt is a T1, meaning that material news is coming down the line, and chances are that this material news will be released today. With the NASDAQ not providing details as to why the stock was halted, we did some digging to see if any material news expectations line up with today’s date, and we found what we believe to be the cause for the halt.
PTIE is a company that’s working on a long-acting, abuse-resistant version of oxycodone, a powerful painkiller. However, the product, Remoxy ER, is formulated with ORADUR technology that was licensed from Durect Corp. At the moment, the company has a New Drug Application in with the FDA with the hopes of bringing this drug to market. The PDUFA date on this application is still a bit over a month away (August 7, 2018), but there is a near-term catalyst that’s likely to take place today.
Before making their decision on whether or not to approve prescription drugs, the FDA tends to look to an Advisory Panel of experts to get their thoughts on the treatment. Well, it is expected that the advisory panel will meet with regard to Remoxy today, providing their vote with regard to whether or not the treatment should be approved. Historically, unanimous votes to approve lead to a nearly perfect rate of approvals. However, mixed results or a vote to reject will likely lead to a rejection from the FDA. So, today’s panel decision is incredibly important for PTIE and its investors.
Where The Stock Sits Now
As mentioned above, Pain Therapeutics is currently halted. This means that no trading is happening and we’re not seeing any action in the market. Nonetheless, yesterday proved to be a pretty strong day, with the stock closing at $8.53 per share after a gain of $0.30 per share (3.65%) as investors moved on anticipation of today’s news.
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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 story surrounding the FDA’s advisory panel surrounding Remoxy ER, as this news will provide a clear line of what to expect moving forward. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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