Trevena opioid painkiller fails to win FDA approval

Trevena (TRVN ) has received a CRL from the FDA in response to its marketing application seeking approval for pain med oliceridine, a not-unexpected action considering the close-but-negative vote from an advisory committee.

Shares, currently halted, will resume trading at 2:10 pm ET.

Previously: Trevena down 13% premarket after negative Ad Com vote (Oct. 12)

Update: Shares are down 33% on more than a 4x surge in volume in the last hour of the session.

Update: The CRL cited the need for additional data on a measure of heart function called QT prolongation, a larger safety database, more nonclinical data and validation reports.

https://seekingalpha.com/news/3404871-fda-rejects-trevenas-oliceridine