Vivus (VVUS) Qnexa PDUFA Delay a "Minor Hiccup" - Leerink Swann
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Rating Summary:
3 Buy, 6 Hold, 4 Sell
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Today's Overall Ratings:
Up: 8 | Down: 5 | New: 26
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 8 | Down: 5 | New: 26
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Leerink Swann commented on Vivus (NASDAQ: VVUS) following the three month Qnexa PDUFA date extension.
"Overall, we believe this represents a minor delay and it does not change our opinion of Qnexa approval without a pre-approval CV outcomes study."
Commenting further, the firm notes that even with the delay Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) lorcaserin (PDUFA date 6/27/12) will not be able to wrest significant firstmover advantage on Qnexa. More importantly, they say, is that the delay may indicate that the FDA is leaning toward an approval since the agency could have issued a CRL on 4/17 if it was certain that a pre-approval CV outcomes trial is necessary.
The firm reiterated their Outperform rating and high $20s valuation.
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 $22.92 yesterday.
"Overall, we believe this represents a minor delay and it does not change our opinion of Qnexa approval without a pre-approval CV outcomes study."
Commenting further, the firm notes that even with the delay Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) lorcaserin (PDUFA date 6/27/12) will not be able to wrest significant firstmover advantage on Qnexa. More importantly, they say, is that the delay may indicate that the FDA is leaning toward an approval since the agency could have issued a CRL on 4/17 if it was certain that a pre-approval CV outcomes trial is necessary.
The firm reiterated their Outperform rating and high $20s valuation.
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 $22.92 yesterday.
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