Pain Therapeutics Inc. ($PTIE) stock jumped over 55 percent in the pre-market session for Tuesday as the company announced receiving the FDA feedback regarding the additional studies needed to refile its New Drug Application seeking approval of abuse-deterrent REMOXY ER (extended-release oxycodone capsules CII). The update followed a meeting between Pain Therapeutics and the FDA held on February 13, 2017. Both the parties had reached an agreement on the requirements for additional assessment for Remoxy’s approval.
Pain Therapeutics will conduct the studies to fulfill dual requirements including an assessment of clinical abuse potential via the intranasal route of abuse, and an assessment of a non-clinical abuse potential using household solvents.
The company recently announced its fourth quarter and full year results. It incurred a loss of $14.9 million for the full financial year. On per share basis, the loss stood at $0.33 per share. For the fourth quarter, its loss stood at $0.06 per share.
Pain Therapeutics stock has gained 68 percent this year so far. However, its stock dipped over 55 percent in the past 12 months. It is currently trading over 50 percent lower than its 52 weeks high of $3, thus offering a good entry point for mid to long term investors.