On Wednesday, September 10, 2014, the NASDAQ Composite ended at 4,592.29, up 0.20%, the Dow Jones Industrial Average declined 0.15%, to finish the day at 17,111.42, and the S&P 500 closed at 2,001.54, down 0.31%. The losses were broad based as eight out of ten sectors ended the session in negative. The S&P 500 Health Care Sector Index ended the day at 741.59, up 0.05%, … Continue reading Biotech Stock Review : Keryx, Sangamo, Regeneron Pharma, Sunesis & Idera Pharma

Alexion Pharmaceuticals’ (ALXN) sole marketed product is Soliris (eculizumab). Soliris is available for the treatment of two rare genetic disorders – paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. As the company is entirely dependent on Soliris for growth, it should look to avoid any setback related to the product. However, the FDA seems to be far from pleased with Soliris’ manufacturing facility at Rhode … Continue reading Biotech Stock Update: Alexion’s Soliris Manufacturing Facility Fails Test

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 … Continue reading Biotech Stock Update: Biotech Stocks Weekly Round Up

BioMarin Pharmaceutical (BMRN) lowered its guidance for 2014 revenues after a thorough evaluation of its transaction with Regeneron Ireland, an indirect, wholly owned subsidiary of Regeneron Pharmaceuticals. Along with its earnings release last month BioMarin had announced the sale of the rare pediatric disease priority review voucher for $67.5 million to Regeneron. The biopharmaceutical company was awarded the voucher under an FDA program to encourage … Continue reading Biotech Stock News: BioMarin Updates 2014 Revenue View

Aegerion Pharmaceuticals, Inc (AEGR) announced that the Office of Prescription Drug Promotion (OPDP) of the FDA has issued a closeout letter with regard to its investigation of the company’s marketing and sales of Juxtapid in the U.S. The closeout letter signifies that the issues mentioned in the FDA’s warning letter have been resolved. Aegerion’s shares gained 5.07% following the announcement. Juxtapid is approved as an … Continue reading Biotech Stock Update: Aegerion Resolves FDA’s Warning

Repros Therapeutics Inc (RPRX) announced positive top-line data on its secondary hypogonadism candidate, Androxal, from a pivotal phase III study. Repros had initiated two identical, 17-week, double-blind ZA-304 and ZA-305 studies to compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function. The ZA-305 study was the first of the two identical pivotal … Continue reading Biotech Stock News: Repros Stock Set For a Rise in Price