Needham & Company Reiterates a 'Buy' on Vivus (VVUS); FORTRESS Results Announced
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Price: $0.47 --0%
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 11 | Down: 18 | New: 20
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 11 | Down: 18 | New: 20
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Needham & Company reiterates a 'Buy' on Vivus (NASDAQ: VVUS) price target of $15.00.
Needham analyst says, "Vivus announced top-line results yesterday from FORTRESS, a retrospective analysis of claims databases designed to assess topiramate risk for birth defects. Qnexa is comprised of topiramate and phentermine. A statistically significant difference in number of oral cleft (OC) cases was observed in a cohort of women treated with topiramate compared to a control cohort of women with a ‘similar medical profile’ (0.07% vs. 0.36% or 5.44x; 95% CI 2.03-14.61). Other equally relevant comparisons were also made and pointed to increased risks of only 1.88x and 2.36x. Nevertheless, we expect regulators to be inherently drawn to the highest number."
"An FDA Advisory Committee meeting is expected to review the narrow label NDA in 1Q12, ahead of the April 17 Qnexa PDUFA date. We are favorably inclined towards approval next Spring, but incrementally more cautious around a broad label sNDA based on FORTRESS data that may be submitted in 2H12."
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.
Needham analyst says, "Vivus announced top-line results yesterday from FORTRESS, a retrospective analysis of claims databases designed to assess topiramate risk for birth defects. Qnexa is comprised of topiramate and phentermine. A statistically significant difference in number of oral cleft (OC) cases was observed in a cohort of women treated with topiramate compared to a control cohort of women with a ‘similar medical profile’ (0.07% vs. 0.36% or 5.44x; 95% CI 2.03-14.61). Other equally relevant comparisons were also made and pointed to increased risks of only 1.88x and 2.36x. Nevertheless, we expect regulators to be inherently drawn to the highest number."
"An FDA Advisory Committee meeting is expected to review the narrow label NDA in 1Q12, ahead of the April 17 Qnexa PDUFA date. We are favorably inclined towards approval next Spring, but incrementally more cautious around a broad label sNDA based on FORTRESS data that may be submitted in 2H12."
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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