Tuesday turned out to be a nightmare for shareholders of Trevena (TRVN), as the stock price plummeted 64% in the wake of negative FDA briefing documents. The documents were released ahead of October 11 AdCom meeting, which will discuss the approvability of TRVN’s post-op pain drug, oliceridine. Unfortunately for investors and patients alike, the FDA provided its unfavorable views for both the efficacy and safety profile of oliceridine.
In reaction, Jefferies analyst Biren Amin downgraded TRVN stock from Buy to Hold, while slashing the price target from $10.00 to $1.00, which implies a potential downside of 15% from current levels. (To watch Amin’s track record, click here)
Amin commented, “A secondary objective of the studies was to demonstrate the superiority of oliceridine to morphine in terms of respiratory safety burden. To our surprise, TRVN proposed endpoint for assessing respiratory safety burden was not supported by FDA, and this information was not disclosed to the public following the end-of-phase 2 FDA meeting. Further, when evaluating this endpoint in both studies, none of the oliceridine treatment arms demonstrated a stat sig reduction in the expected cumulative duration of respiratory safety events compared to morphine. Other notable safety issues in the clinical programs included hepatic adverse events and QT prolongation, which may require add’l data to ease FDA’s concerns. Overall, it seems there are too many issues w/ oliceridine, and we expect a negative AdCom vote on Oct 11 […] Given no clear path forward, we move to a hold with a cash based PT at $1.”
Net net, TRVN has a lot of disappointed bulls out today as the stock plummets, as according to TipRanks, out of 7 analysts polled in the last 12 months, 5 rate a Buy on Trevena stock while 2 issue a Hold. As of this writing, Trevena share are up nearly 5% to $1.12. (See TRVN’s price targets and analyst ratings on TipRanks)