The sluggish shares of Titan Pharmaceuticals (OTCBB: TTNP) that had dropped to as low as near a dollar again received a boost on Wednesday when the company announced the outcome of its heavily-anticipated meeting with the FDA regarding the regulatory path to approval for Probuphine, a treatment for opioid addiction.
Shares had slipped since news of the positive confirmatory Phase III trial for Probuphine hit the wires earlier this year, in part due to concerns that this trial - in conjunction with others before it - would not be enough to warrant an FDA approval for the condition.
Those fears may have been alleviated on Wednesday.
According to a company press release , Titan walked away from its meeting with the FDA confident that additional trials or data would not be needed before filing for Probuphine approval. This news hit wary investors with a flush and TTNP quickly rose 20% on heavy volume during opening trading on Wednesday.
With the future of Probuphine now a lot more firm than it was yesterday, another trip towards two dollars is possible as investors anticipate an approval filing. It's also likely that some takeover talk will be renewed, given the fact that any potential acquiring company also has a much clearer picture of where Probuphine stands and can value accordingly.
A more detailed plan and path for approval filing will be outlined in the coming weeks, according to Wednesday's press release, and investor interest in the company could be reinvigorated in the meantime.
In addition to the Probuphine potential, which also includes a possible approval for the treatment of chronic pain, Titan receives an 8% royaly on sales of Vanda Pharmaceuticals' (VNDA) schizophrenia drug, Fanapt, which is partnered with Novartis (NVS).
Time to keep an eye on Titan again.
Disclosure: Long TTNP.