Needham & Company Reiterates a 'Buy' on Vivus (VVUS); Qnexa FDA Advisory Committee Meeting Preview
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Price: $0.47 --0%
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
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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Needham & Company reiterates a 'Buy' on Vivus (NASDAQ: VVUS) price target of $15.00.
Analyst, Alan Carr, said, "The FDA Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review Qnexa for obesity on 2/22/12. The risk of birth defects is likely to be at the center of discussion. Vivus resubmitted the NDA last year with a contraindication for women of child-bearing potential. However, the FDA requested in January that the company remove the contraindication. We presume the FDA did so to align Qnexa with the existing topiramate label (category D) and to ensure the matter is reviewed in that context by the AdCom."
"Removal of the contraindication raises concerns since it limits Vivus’ flexibility if the committee appears set against use by women of child-bearing potential. Nevertheless, we remain overall favorably inclined on a positive vote and FDA approval. Additional information has been submitted with the new NDA, including impressive 2-yr weight loss data. Fundamentally, we believe strong Qnexa efficacy and the presence of its component drugs on the market (at higher doses) presents a compelling case."
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 $11.99 yesterday.
Analyst, Alan Carr, said, "The FDA Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review Qnexa for obesity on 2/22/12. The risk of birth defects is likely to be at the center of discussion. Vivus resubmitted the NDA last year with a contraindication for women of child-bearing potential. However, the FDA requested in January that the company remove the contraindication. We presume the FDA did so to align Qnexa with the existing topiramate label (category D) and to ensure the matter is reviewed in that context by the AdCom."
"Removal of the contraindication raises concerns since it limits Vivus’ flexibility if the committee appears set against use by women of child-bearing potential. Nevertheless, we remain overall favorably inclined on a positive vote and FDA approval. Additional information has been submitted with the new NDA, including impressive 2-yr weight loss data. Fundamentally, we believe strong Qnexa efficacy and the presence of its component drugs on the market (at higher doses) presents a compelling case."
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 $11.99 yesterday.
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