Merck's (MRK) Suvorexant Faces Challenges at FDA
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Rating Summary:
24 Buy, 7 Hold, 1 Sell
Rating Trend:
Down
Today's Overall Ratings:
Up: 6 | Down: 5 | New: 3
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Leerink Swann today maintained a Market Perform rating on Merck (NYSE: MRK). Recent FDA statements question the safety of sleep aid Suvorexant at higher doses.
Commenting, analyst Seamus Fernandez said, "FDA documents for suvorexant are supportive of the drug's efficacy but clearly question the safety of the higher 30-40 mg dose, the primary dose MRK plans to market, over that of the lower 15-20 mg doses. Additionally, FDA specifically states in the document that 'Indeed, if a dosage strength lower than 15 mg is unavailable, we would need to consider if the drug could be marketed safely at all, if we believe that a substantial proportion of the indicated population needs a lower dose.' Given the relatively strong statements in the documents regarding safe use, including evidence of next day impairment, elevated numeric imbalances in suicidal ideation at the higher dose, as well as possible REM Sleep Behavior Disorder and Narcolepsy-like syndrome, we expect a contentious panel discussion."
For an analyst ratings summary and ratings history on Merck (NYSE: MRK) click here. For more ratings news on Merck click here.
Shares of Merck closed at $45.99 yesterday.
Commenting, analyst Seamus Fernandez said, "FDA documents for suvorexant are supportive of the drug's efficacy but clearly question the safety of the higher 30-40 mg dose, the primary dose MRK plans to market, over that of the lower 15-20 mg doses. Additionally, FDA specifically states in the document that 'Indeed, if a dosage strength lower than 15 mg is unavailable, we would need to consider if the drug could be marketed safely at all, if we believe that a substantial proportion of the indicated population needs a lower dose.' Given the relatively strong statements in the documents regarding safe use, including evidence of next day impairment, elevated numeric imbalances in suicidal ideation at the higher dose, as well as possible REM Sleep Behavior Disorder and Narcolepsy-like syndrome, we expect a contentious panel discussion."
For an analyst ratings summary and ratings history on Merck (NYSE: MRK) click here. For more ratings news on Merck click here.
Shares of Merck closed at $45.99 yesterday.
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