Near Term Approval of Durect (DRRX) REMOXY Likely as FDA Panel Deemed Unnecessary - Rodman & Renshaw
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Rodman & Renshaw analyst Raghuram Selvaraju reiterated a Buy rating and $4 price target on Durect Corp (NASDAQ: DRRX) after the company and Pain Therapeutics (NASDAQ: PTIE) announced last week that the FDA had determined that an Advisory Committee meeting for REMOXY, which had been tentatively scheduled for August 5, 2016, is unnecessary and will not be held. REMOXY was previously the subject of an Advisory Committee meeting in 2008. The FDA has also communicated that the review of the REMOXY NDA remains active and on-going. The PDUFA date for the REMOXY®NDA, set as September 25, 2016, is unchanged.
Selvaraju commented, "We believe this suggests that the efficacy and safety profile of REMOXY has been well presented in the NDA package, from the FDA’s perspective, and additional application material is unlikely to be requested. Therefore, in our view, REMOXY® is likely to secure regulatory approval in September. In the wake of this update and in anticipation of the product's approval near-term, we reiterate our Buy rating and $4 price target."
For an analyst ratings summary and ratings history on Durect Corp click here. For more ratings news on Durect Corp click here.
Shares of Durect Corp closed at $1.25 yesterday.
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