Sunesis: Vosaroxin Approval In The US And EU Is Unlikely, Says Wedbush


In a research report issued October 6 to investors, Wedbush analyst David Nierengarten reiterated a Neutral rating on Sunesis Pharmaceuticals (NASDAQ:SNSS) and significantly reduced his price target to $2 (from $10), following the news that the company’s Vosaroxin (Qinprezo) plus cytarabine failed to meet the primary endpoint of a statistically significant OS improvement in r/r AML patients versus cytarabine plus placebo in the VALOR study.

The following bullets contain some highlights from the report:

  • As we predicted, higher-than-expected rates of stem cell transplants (SCT) negated the OS benefit of vosaroxin, with vosaroxin demonstrating statistical significance once the transplant impact was removed (median OS of 6.7 vs 5.3 months, p=0.02; HR=0.809). Approximately 30% of patients had a transplant in the study, higher than the 26% of patients who advanced to SCT in the Phase II trial. Vosaroxin did meet the secondary endpoint of a significant benefit in complete response rate (30.1% vs. 16.3%, p<0.001).
  • Statistically significant OS benefits in the pre-stratified elderly population subset could be a potential path to approval in EU, albeit one we view with a low probability of success.
  • We believe approval in the US is highly unlikely, considering the FDA’s longstanding emphasis on OS and reluctance to approve a drug in AML based on a subset analysis.

According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst David Nierengarten has a total average return of 7.2% and a 46.5% success rate. Nierengarten has a 4.8% average return when recommending SNSS, and is ranked #788 out of 3334 analysts.

 

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