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Biotech Stocks Facing FDA Decision In August 2020

Trevena
Trevena

Trevena Inc.’s (TRVN) investigational pain drug Oliceridine, is back at the FDA altar again, with a decision expected on August 7, 2020.

Oliceridine, an intravenously-administered mu-opioid receptor agonist, was denied approval in November 2018, and the company was asked to submit additional clinical data on QT prolongation and was also informed that the submitted safety database was not of adequate size for the proposed dosing.

Addressing the concerns raised by the FDA, the company resubmitted the Oliceridine NDA in February of this year, which was categorized as a Class II response, with the time frame for completing the review being 6 months.

Last year, the FDA had withdrawn the Breakthrough Therapy designation granted for Oliceridine, saying that the phase III data were not sufficient to support the continuation of that status.

TRVN closed Friday’s (Jul.24, 2020) trading at $1.98, up 2.59%.