Wells Fargo Sees 3-Month PDUFA Delay for Vivus' (VVUS) Qnexa
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Rating Summary:
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Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
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Analysts at Wells Fargo weighed in on Vivus (NASDAQ: VVUS) following the FDA panel meeting on CV risk for obesity drugs.
The firm said while the meeting does not materially change Qnexa's approvability, a three-month extension to Qnexa's PDUFA date is likely.
They note the AdCom favored a two-tier approach to CV risk assessment (part pre-approval, part post-approval).
"Since FDA already has a comprehensive data package on Qnexa CV safety profile, a formal CRL appears less likely," the analyst said.
While they think Qnexa ultimately gets approved, commercialization risks remains. The firm maintained their Market Perform rating and $21 to $24 valuation range.
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 $21.28 yesterday.
The firm said while the meeting does not materially change Qnexa's approvability, a three-month extension to Qnexa's PDUFA date is likely.
They note the AdCom favored a two-tier approach to CV risk assessment (part pre-approval, part post-approval).
"Since FDA already has a comprehensive data package on Qnexa CV safety profile, a formal CRL appears less likely," the analyst said.
While they think Qnexa ultimately gets approved, commercialization risks remains. The firm maintained their Market Perform rating and $21 to $24 valuation range.
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 $21.28 yesterday.
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