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lgonber

06/10/15 11:28 AM

#192337 RE: DewDiligence #192335

Does not look good at all. I was considering to get in ESPR but watching on the sidelines for the moment.
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DewDiligence

06/10/15 5:08 PM

#192350 RE: DewDiligence #192335

FDA panel backs AMGN’s Repatha (PCSK9) for high-risk patients:

http://finance.yahoo.com/news/fda-panel-backs-amgens-cholesterol-203720826.html

The panel voted unanimously to approve the drug, known also as evolocumab, for patients with homozygous familial hypercholesterolemia (HoFH), a hereditary disorder that causes high LDL and can cause heart attacks in very young people, including children.

They voted 11-4 to approve Repatha in patients with high cholesterol who are at high risk of cardiovascular disease whose cholesterol cannot be lowered sufficiently using statins or other drugs.

AMGN was flattish in regular-hours trading and is +1% in the AH session.

ESPR was -19% in regular-hours trading and is +1% in the AH session.

REGN was -3% in regular-hours trading and is flattish in the AH session.
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DewDiligence

07/07/15 10:12 AM

#193201 RE: DewDiligence #192335

ESPR—FDA removes partial clinical hold on ETC-1002:

http://finance.yahoo.com/news/esperion-therapeutics-announces-removal-240-120000888.html

This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.