Prana Biotechnology shares surged 18.7% after the company announced that the FDA has granted orphan drug designation to its Huntington disease candidate, PBT2. We note that the FDA grants orphan drug designation to candidates being developed to treat rare diseases that affect less than 200,000 people in the U.S. The status makes the candidate eligible for seven years of marketing exclusivity in the U.S. following … Continue reading Prana Biotech Stock Soaring high Due to Positive Reports

The FDA has approved Keryx Biopharmaceuticals, Inc’s (KERX) ferric citrate to control serum phosphorus levels in patients suffering from chronic kidney disease (CKD) on dialysis. However, the news adversely affected the stock price, which fell more than 5%, as the drug was approved with several warnings. Ferric citrate is not recommended for patients with an accumulation of iron (hemochromatosis) in their body. Treatment with ferric … Continue reading Biotech Stock Update: Keryx Falls after Ferric Citrate’s Tests

In order to boost its pipeline, AbbVie Inc (ABBV) inked a collaboration agreement with Infinity Pharmaceuticals (INFI) to develop and commercialize the latter’s oncology candidate duvelisib (IPI-145). Infinity Pharma’s shares jumped over 44% following the announcement. AbbVie will be making an upfront payment of $275 million to Infinity Pharma to jointly commercialize duvelisib in the U.S. and will share the potential profits or losses equally. … Continue reading Biotech Stock Abbvie can only Rise : here is why

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