Needham & Company Remains Cautious on Arena Pharma (ARNA) Given Lingering Uncertainty Around Rat Mammary Tumors; Lorcaserin NDA Resubmitted
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Price: $99.98 --0%
Rating Summary:
10 Buy, 13 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 7 | Down: 12 | New: 19
Rating Summary:
10 Buy, 13 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 7 | Down: 12 | New: 19
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Needham & Company maintains a 'Hold' on Arena Pharma (NASDAQ: ARNA).
Needham analyst says, "Arena announced after market close that the company has completed a series of lorcaserin preclinical and clinical studies and that an NDA was resubmitted to the FDA on 12/27/11. The company had previously announced that a reanalysis of rat carcinogenicity data demonstrated that a large safety margin exists around malignant mammary tumors in female rats, but that there is no safety margin around benign mammary tumors. We believe the increase in benign tumors in lorcaserinexposed rats may be of concern to the FDA and identification of a mechanism of action that is irrelevant to humans is a gating event for lorcaserin approval."
"Based on data disclosed yesterday, Arena appears to have made progress in this regard, however, in our view, there may still be sufficient uncertainty to delay approval of lorcaserin. Given the broader context of a modest lorcaserin weight-loss benefit, we remain cautious and maintain our rating."
For an analyst ratings summary and ratings history on Arena Pharma click here. For more ratings news on Arena Pharma click here.
Shares of Arena Pharma closed at $1.92 yesterday.
Needham analyst says, "Arena announced after market close that the company has completed a series of lorcaserin preclinical and clinical studies and that an NDA was resubmitted to the FDA on 12/27/11. The company had previously announced that a reanalysis of rat carcinogenicity data demonstrated that a large safety margin exists around malignant mammary tumors in female rats, but that there is no safety margin around benign mammary tumors. We believe the increase in benign tumors in lorcaserinexposed rats may be of concern to the FDA and identification of a mechanism of action that is irrelevant to humans is a gating event for lorcaserin approval."
"Based on data disclosed yesterday, Arena appears to have made progress in this regard, however, in our view, there may still be sufficient uncertainty to delay approval of lorcaserin. Given the broader context of a modest lorcaserin weight-loss benefit, we remain cautious and maintain our rating."
For an analyst ratings summary and ratings history on Arena Pharma click here. For more ratings news on Arena Pharma click here.
Shares of Arena Pharma closed at $1.92 yesterday.
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