Jefferies Maintains Negative View on Vivus (VVUS) In Light of FORTRESS Data

Jefferies reiterated their Underperform rating and $3 price target on Vivus (NASDAQ: VVUS) following topline results from the FORTRESS birth defects study. The firm said the regulatory pathway remains risky.

The FORTRESS birth defects study of topiramate showed the relative risk for oral cleft of up to 5.44-fold in topiramate patients versus control.

"We believe VVUS' post-hoc analysis suggesting the 5.44-fold increase is overestimated is unlikely to be persuasive to the FDA, analyst Thomas Wei said. "These data leave us more cautious for a broad approval covering women of child bearing age."

Wei said the FORTRESS data leads them to be cautious on a broad label.

"We are concerned not only by the 5.44-fold increased risk in oral clefts but also by the lower bound of the confidence interval crossing 1 (i.e. there is at least a two-fold increase in risk) and the upper bound being very high (i.e. the risk could be as high as a 15-fold increase)."

For an analyst ratings summary and ratings history on Vivus click here. For more ratings news on Vivus click here.

Shares of Vivus closed at $10.40 yesterday.

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