Upcoming Phase 3 trials

With a fresh start to 2014 and the biotech market still very strong, we wanted to examine some upcoming Phase 3 results that will be in focus in the first quarter. Expectations for some of these trials varies widely. We have a blend of small biotech to big pharma. Company: Merck (MRK) and Amgen (AMGN) […]

AEGR – Quick commentary on Aegerion

Aegerion has been one of the best performing stocks over the past 6-12 months. This has been driven by the value creation of Juxtapid (lomitapide), a small molecule microsomal triglyceride transfer protein inhibitor, was approved by the FDA and EMA adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, in […]

Week’s Option Activity (5/13~5/17)

The following stocks had notable activity in their options during the past week: $OPTR (5/13): 2,250 SEP 17.50 strike Calls were sold against equal number of purchased JUN 12.5 Puts (stock @ $12.81) for total debit of 0.85 or $191,250. Trade most likely a hedge of an existing long stock position. $MNTA (5/13): 926 JAN14 […]

ISIS and AEGR – Where do they stand after the FDA Advisory Committee meetings?

October 17 and 18, 2012 saw back-to-back meetings of the FDA Endocrine and Metabolic Drugs Advisory Committee (EMDAC) to review pending new drug applications (NDAs) for two drugs for homozygous familial hypercholesterolemia (HoFH): lomitapide from Aegerion Pharma (NASDAQ: AEGR) and mipomersen/Kynamro from Sanofi/Genzyme and Isis Pharma (NASDAQ: ISIS). As Chimera predicted, both drugs received positive […]

An October full of data and decisions

With October underway, we felt the need to highlight some of the most important upcoming data readouts and regulatory decisions. This month is particularly busy on the regulatory side of things with 5 PDUFAs, 4 Advisory Committees, 6 FDA actions, and multiple potential European Medicines Agency(EMA) decisions. The events are listed in chronological order. Eli […]