Biotech Stock Update: Biotech Stocks Weekly Round Up

Biotech Stock

Highlights in the biotech sector last week include a favorable court ruling for United Therapeutics’ (UTHR) in a patent infringement case, positive late-stage data on Repros Therapeutics’ (RPRX) testosterone replacement treatment and the filing of the first Biologics License Application (BLA) for a PCSK9 inhibitor.

United Therapeutics scored a huge win in its patent infringement lawsuit against Sandoz regarding Remodulin. The favorable ruling has removed a significant overhang on the shares, which were up 28.5% on the news. The company touched a new 52-week high early this week.

It was an eventful week on the pipeline front for Amgen (AMGN). The company said that its chronic heart failure drug, ivabradine, will be reviewed on a priority basis by the FDA. Amgen also submitted its PCSK9 inhibitor, evolocumab, for FDA approval. Evolocumab is one of the most important candidates in Amgen’s pipeline and represents huge commercial potential, once approved and launched.

Biotech Stock News

Repros’ shares surged 18.5% with the company reporting positive late-stage data on its key pipeline candidate, Androxal. The testosterone replacement treatment was found to be superior to a currently approved product. Repros expects to file for approval in the U.S. by year end.

Aegerion (AEGR) shares were up 5.1% on news that the FDA’s warning letter regarding certain statements made regarding cholesterol drug, Juxtapid, has been resolved. BioMarin (BMRN), which had sold its Vimizim related rare pediatric disease priority review voucher to Regeneron, cut its 2014 revenue guidance. The change was based on the company’s decision to treat the proceeds from the one-time sale as “gain on the sale of intangible assets”. While revenue guidance was cut by $65 million, other aspects remained unchanged

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Biotech Financial News

Last week, Gilead (GILD) continued to rise with its price increasing 2.91%. Regeneron’s shares moved up 1.54%. Alexion was the biggest loser among the big biotechs with its shares declining 1.82%. The company, which had already received a warning letter from the FDA last year for its Rhode Island manufacturing facility, received a Form 483 with three inspectional observations from the FDA late last month.

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