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Biotech / Medical : biotech firesales

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scaram(o)uche
From: tnsaf6/10/2015 9:54:29 AM
1 Recommendation   of 3661
 
Why Esperion Shares Are Down 18% Today
Matthew Herper Forbes Staff

Shares of Esperion Therapeutics are down 18% [24% 10 am] to about $83 in pre-market trading this morning. I explained this in my story on yesterday’s Food and Drug Administration advisory committee meeting on Regeneron’s cholesterol drug Praluent, but it seems worth re-iterating the reason here.

Esperion is developing a pill, ETC-1002, that can reduce LDL cholesterol by 40%. But it has been targeting patients who are intolerant to statins — meaning they can’t take Crestor, atorvastatin, or simvastatin because of muscle pain or other side effects — as a potential population in which the drug can be approved.

But the FDA panel was pretty clear that it didn’t think that approving a drug for patients who can’t tolerate statins is a good idea, at least without hard proof that the drug can prevent heart attacks and strokes, as statins do. Nine of the sixteen panelists said that they were against a statin intolerant indication without such data. This means that Esperion might have to shift it’s strategy, or face a tougher road.
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