Wells Outlines Paths for VIVUS (VVUS) Following CHMP Denial of Qsiva Marketing App
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Price: $0.47 --0%
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 16 | Down: 11 | New: 13
Rating Summary:
3 Buy, 6 Hold, 4 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 16 | Down: 11 | New: 13
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VIVUS, Inc. (Nasdaq: VVUS) shares are higher on the session following a release late Thursday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) formally recommended against approval of the Marketing Authorization Application (MAA) for Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union. The move was expected given early indications from the Committee in September.
In the release, VIVUS noted that it will appeal the opinion and request a re-examination of the decision by the CHMP.
Well Fargo commented on the decision today, maintaining all of its current estimates given it anticipated an 18-month EU delay for Qsiva. The firm said that possible paths forward for VIVUS include: "conditional approval following appeal (6-9 months turnaround), resubmission with additional data (1-2 year turnaround minimum), and abandonment (if pre-approval requirements are too onerous)."
Given the focus of VIVUS' prescription ramp in the U.S. for Qsymia, Wells is maintaining a Market Perform rating and valuation range of $21 to $23 on the stock. Concerns for Wells are the growth trajectory (insufficient data to call a trend yet) and the sustainability of Rx growth (uncertainty in long-term patient compliance).
Notably, VIVUS submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia, which would allow dispensing through a broader range of certified pharmacies, specifically select retail pharmacies, to increase access while meeting all requirements of the REMS.
Shares of VIVUS are up about 1.6 percent Friday.
In the release, VIVUS noted that it will appeal the opinion and request a re-examination of the decision by the CHMP.
Well Fargo commented on the decision today, maintaining all of its current estimates given it anticipated an 18-month EU delay for Qsiva. The firm said that possible paths forward for VIVUS include: "conditional approval following appeal (6-9 months turnaround), resubmission with additional data (1-2 year turnaround minimum), and abandonment (if pre-approval requirements are too onerous)."
Given the focus of VIVUS' prescription ramp in the U.S. for Qsymia, Wells is maintaining a Market Perform rating and valuation range of $21 to $23 on the stock. Concerns for Wells are the growth trajectory (insufficient data to call a trend yet) and the sustainability of Rx growth (uncertainty in long-term patient compliance).
Notably, VIVUS submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia, which would allow dispensing through a broader range of certified pharmacies, specifically select retail pharmacies, to increase access while meeting all requirements of the REMS.
Shares of VIVUS are up about 1.6 percent Friday.
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