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Roth Capital: Palatin Technologies Still A Buy, Worth $4/Share

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In a report published Friday, Roth Capital analyst Joseph Pantginis reiterated a Buy rating and $4 price target on Palatin Technologies, Inc. (NYSE: PTN). The majority positive vote for flibanserin by the FDA Advisory Committee bodes well for Palatin's bremelanotide.

Bremelanotide (BMT) is currently in its Phase III RECONNECT study in the treatment of female sexual dysfunction. Flibanserin is possibly the first treatment for female sexual dysfunction to be approved by the FDA. The approval resolves the regulatory overhang on BMT, which the analyst believes should help the stock gain momentum and garner investor attention.

According to the Roth Capital report, "Flibanserin had previously failed twice to prove to the FDA that its benefits outweighed its risks, but finally was able to receive a positive voting after adding several safety studies and risk management strategies. While mainly positive, the AdCom requests certain risk management beyond labeling due to flibanserin's safety profile that includes CNS depression, hypotension and syncope, which are exacerbated when used with alcohol."

The Phase II study for BMT revealed that the drug was well tolerated, while the most commonly reported side effects included facial flushing, nausea and vomiting. These effects were primarily mild-to-moderate in their severity.

Another factor that differentiates BMT from flibanserin is that the former can be used "on demand," while the latter requires daily use. The company expects to complete the Phase III studies on BMT by 2H15 and to report top-line data by mid-2016. Depending on the outcomes of the trials, the company is likely to file its NDA in 4Q16, with the FDA decision expected by 4Q17.

Latest Ratings for PTN

DateFirmActionFromTo
Jun 2015Canaccord GenuityMaintainsBuy
Mar 2015Canaccord GenuityInitiates Coverage onBuy
Jun 2013PiperJaffrayInitiates Coverage onOverweight

View More Analyst Ratings for PTN
View the Latest Analyst Ratings

Posted-In: Roth CapitalAnalyst Color Reiteration Analyst Ratings

 

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