JMP analysts have profiled two biopharmaceutical firms that they believe are set up to do well in the rest of 2018 and beyond. Both companies are due to have important FDA catalysts that could lead to a share price turnaround. Let’s take a closer look.
Trevena: Key Oliceridine Regulatory Events Approaching
Last year, Trevena (NASDAQ:TRVN) submitted a New Drug Application (NDA) for oliceridine, the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer side effects. The FDA will have an AdComm meeting before the PDUFA date on November 2, 2018. According to CEO Maxine Gowen, the company remains in active discussions for oliceridine licensing in the US as it gets closer to commercialization.
JMP analyst Jason Butler is quite bullish on oliceridine’s chances of approval, noting: “Our focus remains on the upcoming FDA advisory committee meeting for oliceridine, expected to be scheduled in October, followed by the November 2 PDUFA date. We continue to believe there is a high probability of approval, and the product profile and management’s targeted launch strategy support commercial success. Assuming on-time approval and DEA scheduling, the company expects to launch oliceridine in 1H19.”
Ahead of the upcoming FDA decision, Butler maintains an Outperform rating on Trevena shares, with a price target of $15.00 per share.
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Jason Butler has a yearly average return of 20.6% and a 50.5% success rate. Butler is ranked #454 out of 4856 analysts.
Ocular: JMP Gets More Confident on DEXTENZA Ahead of PDUFA Date
In July, Ocular Therapeutix (NASDAQ:OCUL) announced that the FDA had accepted its NDA for Dextenza (dexamethasone insert) 0.4mg for the treatment of ocular pain following ophthalmic surgery. The resubmission is considered a class 2 response and a Prescription Drug User Fee Act (PDUFA) has been set on December 28, 2018.
JMP’s Donald Ellis noted, “OCUL had retired FDA inspectors conduct mock inspections of its facility. The inspectors found minor issues, but the company was already aware and addressing the issues. The current management team has extensive experience in pharmaceutical manufacturing and multiple hires were made in compliance and quality control. We are more confident that this management team will successfully address manufacturing deficiencies and that DEXTENZA will be approved in December 2018. Ocular will apply for a C-code with CMS most likely in late 1Q19, with an approval expected in 2Q19. It takes approximately one quarter to receive C-code approval such that we expect an active C-code and revenue generation from Medicare (~50% of patients) beginning in July 2019. Approximately 4M cataract surgeries occur annually in the U.S.”
Net net, Ellis reiterates an Outperform rating on Ocular shares, with a price target of $9.00, which implies an upside of 49% from current levels.
According to TipRanks, analyst Donald Ellis has a yearly average return of 4.5% and a 38.7% success rate. Ellis has a -23.7% average return when recommending OCUL, and is ranked #2252 out of 4856 analysts.