Just a few weeks ago, shares of Titan Pharmaceuticals (NASDAQ:TTNP) were dropping as investors grew wary when the company revealed that the FDA had some questions regarding the Statistical Analysis Plan for the confirmatory Phase III Probuphine trial. Shares hit a low of $1.30 and the almost-sure-thing confirmatory trial (at least as much of a "sure thing" as you can count on in the biotech world) stood on thin ice in the minds of many who were watching.
Any fears were averted this week, however, with the release of top-line results that confirmed the positive outcome of the previous trials.
The study results were clinically meaningful and statistically significant as demonstrated by two primary analyses, which both confirmed the efficacy of Probuphine compared to placebo (p < 0.0001 for the trial's protocol defined primary endpoint based on the percentages of urine samples tested negative for illicit opioid use over the 24-week treatment period and p < 0.0001 for the additional primary efficacy analysis of the urine toxicology with patient self-reported opioid use incorporated) ...
It's also worth noting that Probuphine also demonstrated non-inferiority to the already-approved SUBOXONE treatment.
The news sent Titan shares spiking back to over the $2 mark, but prices never hit much higher than that; in fact, they traded back down towards it later in the week before dropping to the $1.90s. Volume was well above average as well, but not enough to support a more prolific run.
So what gives with the $2 mark? Probuphine holds a novel approach in treating opioid addiction in utilizing Titan's subcutaneous implant ProNeura technology. The product holds even more potential, in my opinion, in treating chronic pain, an indication for which studies are ongoing. That said, the resistance to move this stock to much above two could be an indication that investors feel that, while the technology is sound, the wide-spread market potential might not be there.
Even if it is there, investors know that Probuphine is still a ways away from market, since Titan is looking to schedule a meeting with the FDA later this year to formulate a plan for approval, given the positive results. The truth is, the $2 mark might be the place where investors had already priced in the positive results, and now there's a holding pattern to see what happens next.
Full results, according to Titan's press release, will be presented at "scientific meetings" later this year, while royalty money from Vanda's (NASDAQ:VNDA) Fanpt will continue to roll in. The real key to the future, however, might be talks of partnership deal or a buyout. It's been long speculated that Titan is destined to be acquired by a larger pharma such as Novartis (NYSE:NVS), since there's already a connection there through Fanapt, and now that the Probuphine results are positive, it could be time for a deal to get done. Hence the $2 holding pattern, while the details get worked out.
It's been a long road for Titan, having fully recovered from being a penny play, but there's still a lot of potential ahead. In my opinion, it's just a matter of time before this $2 level is history.
Disclosure: I am long TTNP.