Healthcare Review: NewLink Genetics, Celldex, Dendreon, Pfizer, GSK Print E-mail
By Staff and Wire Reports   
Monday, 03 March 2014 16:30
Global stocks fell sharply Monday on rising tension over Russia's military advance into Ukraine and the threat of possible sanctions by Western governments. Treasurys and gold prices rose as investors bought safer assets. The price of crude oil rose as traders worried that Russian oil exports could be disrupted. The Standard & Poor's 500 index fell 19 points, or 1.1 percent, to 1,839 as of 12:24 p.m. (1724 GMT). The index is on track for its biggest drop in a month. The Dow Jones industrial average fell 217 points, or 1.3 percent, to 16,106. The Nasdaq composite dropped 60 points, or 1.4 percent, to 4,247.

Shares of NewLink Genetics ($NLNK) are down today, continuing its sharp reversal from Friday's high of $53.48, on a Robert W. Baird downgrade to Neutral. Shares are currently trading just under $40, down 25% from the peak of euphoria last week. Investors expect the company to report its Q4 and FY13 results today. Shares were up 155% year-to-date prior to the reversal. Mutual fund ownership has increased from 104 to 124 over the past 4 quarters.

Shares of Celldex ($CLDX) are sharply lower in today's trading despite meeting its consensus Q4 estimates.2014 guidance includes completing the accruals of the P3 ACT IV and P2 ReACT clinical trials for rindopepimut, completing the accrual of glembatumumab's METRIC study for triple negative breast cancer as well as initiating two P2 trials for other cancers and initiating three P1 and/or P1/2 trials for varlilumab. Quick assets totaled $303M at year's end, sufficient to fund the company's operations through 2016.

Dendreon ($DNDN) jumps 20% after the company's Q4 earnings top expectations and the company says it plans to sell Provenge in Europe, beginning with Germany and the UK. The EMA granted marketing approval in September. Dendreon will initially look to sell the therapy to medical institutions that treat large numbers of prostate cancer patients; once production is ramped up, the company will consider making Provenge more widely available.EU approval covers 28 countries in the Union as well as Norway, Iceland and Liechtenstein. Dendreon's FY revenues were $283.7M, in line with consensus, while losses per share was $1.95, worse than forecasts of $1.74.

Pfizer ($PFE) is proceeding with plans to commercialize an over-the-counter version of its blockbuster cholesterol-lowering drug Lipitor. The decision is controversial because some health experts believe that the drug should only be dispensed under a doctor's care due to the risk and to the difficulty for the general public of understanding how people's health is assessed. A 1200-person trial is underway to determine if the lower dose of Lipitor reduces patients' cholesterol vs generics available by prescription and if patients follow through on getting their blood tested. The trial should conclude by the year-end.

GSK ($GSK) has called it quits on its GSK2586184 treatment for lupus - which it's developing with Belgian biotech Galapagos (GLPGF) - after a Phase 2 study failed to demonstrate a positive effect. A Phase1/2 trial for ulcerative colitis was put on hold as well, although dosing in a Phase 2 trial for the skin condition psoriasis has just been completed. Galapagos' relationship with Glaxo goes back seven years and included $300M in potential milestone payments. Galapagos was in line for a $34M payment for the start of the Phase 2 study.




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