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FDA Panel Points to Narrower Label for Amgen's (AMGN) Repatha, Nomura Notes

June 11, 2015 8:31 AM EDT
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Price: $284.32 -0.69%

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    20 Buy, 13 Hold, 5 Sell

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Nomura Securities analyst M. Ian Somaiya maintained his Buy rating and $182 price target on Amgen (NASDAQ: AMGN) following FDA panel recommendation for Repatha but notes commentary points to a narrower label.

Somaiya commented, "We believe the recent FDA Advisory Committee panels for Amgen’s Repatha and SNY/REGN’s Praluent have put our and Street estimates at risk despite positive panel votes for both drugs. For Amgen, the committee voted 11-4 in favor of approval and 15-0 in favor of approval in homozygous familial hypercholesterolemia (HoFH). While the positive vote increases our confidence that Repatha will be approved by its Aug 27 PDUFA, we note that as with the Praluent panel on June 9, member comments were again cautious on labeling, safety and the need for positive CV outcomes data to support broader use. Our scenario analysis suggests that a label restricted to HoFH and HeFH (heterozygous familial hypercholesterolemia) would reduce peak sales to $1.4bn and our DCF to $176 (vs. $2.5bn; $182 currently). Reiterate Buy rating and $182 TP."

For an analyst ratings summary and ratings history on Amgen click here. For more ratings news on Amgen click here.

Shares of Amgen closed at $155.55 yesterday.



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