In a research report issued Friday, Piper Jaffray analyst Joshua Schimmer reiterated a Neutral rating on shares of Clovis Oncology Inc (NASDAQ:CLVS) with a price target of $18.00, after the FDA released briefing documents ahead of the Oncologic Drugs Advisory Committee meeting to discuss accelerated approval of the New Drug Application for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.
Schimmer observed, “The FDA review focuses on the overall risk / benefit of CLVS vs. chemotherapy (and not Tagrisso) and likelihood of predicting clinical benefit in a confirmatory study. While the window is open for potential approval given a decent response rate and Tagrisso’s accelerated (not full) approval, CLVS will still need to convince the panel of roci’s superiority to chemotherapy. With the FDA also raising serious concerns with cardiac AEs and proposing a blackbox warning, the commercial outlook in our view is even more uncertainthan the regulatory outlook. Of note, FDA prefers the 500 mg BID dose vs. the 625 mg dose favored by CLVS based on overlapping confidence intervals and PK/PD studies.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Joshua Schimmer has a yearly average return of -15% and a 28.5% success rate. Schimmer is ranked #3771 out of 3854 analysts.
Out of the 4 analysts polled by TipRanks (in the past 3 months), 1 rate Clovis Oncology stock a Buy, while 1 rates the stock a Hold. With a return potential of 59%, the stock’s consensus target price stands at $31.25.