|Healthcare Review: Amarin, Acceleron Pharma, Antares, Coronado Biosciences, NuVasive|
|By Staff and Wire Reports|
|Monday, 14 October 2013 13:29|
Aegis is out defending Amarin ($AMRN) amid a sell-off that has taken the stock down some 22% from where it was trading Friday before the FDA released briefing documents for an upcoming advisory committee meeting for Vascepa. "In our view, the briefing documents were not anywhere near as negative as initial commentary would have investors believe," analyst Ram Selvaraju says, adding that Aegis remains confident "that the panel vote is likely to ratify [the] view that Vascepa is a safe and effective drug for the treatment of mixed dyslipidemia."
Leerink starts Acceleron Pharma ($XLRN) at Outperform. The company is "pushing innovation boundaries with lead compounds for anemia (Sotatercept, ACE-536) and oncology (Dalantercept)," analyst Marko Kozul says. Leerink thinks Sotatercept and ACE-536 "have potential to compete directly with ESAs" such as Aranesp and Epogen and Procrit. As for Dalantercept (ACE-041), Kozul says it "could be used synergistically with any VEGF-inhibitor."
The FDA approves Antares' ($ATRS) Otrexup for adults with severe active rheumatoid arthritis "who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents, or for children with active polyarticular juvenile idiopathic arthritis [and for] adult use for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy." (PR)The approval was widely expected and has been discussed by several SA contributors including Stock Matusow, Beacon VP Investments, and Paul Reed.
Coronado Biosciences' ($CNDO) TSO did not meet its primary endpoint in a Phase 2 Crohn's disease trial.TRUST-1's primary endpoint was a 100-point decrease in CDAI and its secondary endpoint was remission (CDAI <150 points). Neither endpoint was met in patients with moderate-to-severe Crohn's disease. The company says "the lack of overall response was driven by higher-than-expected placebo response rate in patients with CDAI < 290" and although CEO Harlan Weisman is "disappointed with the topline results," he says the company is "encouraged to see TSO's effect in patients with CDAI > 290."
Goldman downgrades NuVasive ($NUVA) to Sell. Analyst David Roman says "conversations with industry participants" suggest cervical spinal implants (which represent 10-12% of NUVA's sales) could be pressured going forward even as "lumbar fusion insurer pushback seems to have eased."Furthermore, Roman notes that "the ongoing OIG investigation into NUVA's CMS reimbursement filings is ... a risk that is hard to quantify."