Trevena’s (NASDAQ:TRVN) pain drug oliceridine is expecting an FDA decision coming November 2. Furthermore, the FDA has informed the company that it intends to convene an advisory committee meeting to discuss the oliceridine filing (likely in September), which could be a catalyst for shares if positive.
Wall Street analysts continue to believe Olinvo will likely be approved by the FDA based on the draft guidelines and two positive pivotal Phase 3 APOLLO studies and ATHENA safety study.
JMP analyst Jason Butler expressed his high confidence in a positive AdComm recommendation and approval, noting “We continue to believe there is a high likelihood of approval and that the drug’s differentiated clinical profile and commercial opportunity are being misinterpreted by investors […] We do not believe concerns over approval of new oral formulations of opioids are relevant to oliceridine as its use will be limited to controlled settings, primarily hospitals, therefore the risk of misuse/ diversion is minimal.”
As such, Butler reiterates an Outperform rating on TRVN shares, with a $15.00 price target, which implies a huge upside of nearly 970% from current levels.
H.C, Wainwright analyst Ed Arce sets a 90% probability of success for oliceridine in the US, and projects peak US sales for OLINVO of $460 million. His bullish outlook on the stock translated into a Buy rating and $7.00 price target (400% upside from current share price).
While much of the organization is focused on U.S. commercial readiness, in anticipation of FDA approval, Arce notes that management remains open to partnering in the U.S., under the right circumstances. The analyst stated, “We note that Trevena continues to progress its early stage pipeline including: 1) TRV250 for acute migraines, with Phase 1 subcutaneous dose ranging data expected in the coming months; and 2) novel S1P modulator compounds for (non-opioid) chronic pain relief, still in preclinical lead selection. We believe that one or both programs may be partnered in 2018 as a means to provide non-dilutive funding and extend the company’s cash runway.”
These analysts are not the only fans of the drug maker on Wall Street, as TipRanks analytics exhibit TRVN as a Strong Buy. Based on 7 analysts polled in the last 12 months, 6 rate a Buy on Trevena stock while 1 issues a Hold. The 12-month average price target stands at $8.58, marking a 522% upside from where the stock is currently trading.