FDA delays action date for Theratechnologies

Theratechnologies (TSX:TH) expects to have an official response from the FDA in the fourth quarter this year about its new drug application for its tesamorelin, a treatment for excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA had originally targeted July 27 to complete its review.

“The FDA has indicated that the review is progressing well,” Theratechnologies said, adding that it and the agency “continue the positive and constructive dialogue regarding the regulatory process for tesamorelin.”

“We do not believe that this should be overly concerning, as it is likely that the FDA requires more time to work through issues that were discussed at its advisory committee meeting,” analyst Neil Maruoka of Canaccord Genuity said in a new report.  “The delay does not impact our view of the tesamorelin’s chances of approval, which we currently estimate to be 90%.”

Noting that the FDA’s advisory committee unanimously recommended approval of tesamorelin in May, Mr. Maruoka said that a pullback in the stock should be viewed as a “buying opportunity, with expectations of a positive FDA decision for tesamorelin towards the end of the year.”

In afternoon trading on Tuesday, Theratechnologies is trading at $4.89, down 59 cents, or 10.8%.