Sanofi-Aventis (NYSE:SNY): Closing price $48.04
On Thursday, the French drug manufacturer Sanofi withdrew its United States application for the diabetes treatment lixisenatide, delaying the drug’s intro to the largest pharmaceutical in the world. The decision sent shares of Sanofi down around 2.5 percent on the day in New York, while Zealand Pharma, its smaller Danish partner for the drug, dropped by 16 percent. Sanofi said that it would resubmit its application to the FDA in 2015, after the completion of an ongoing cardiovascular patient evaluation, and reported that the withdrawal was “not related to safety issues or deficiencies in the new drug application.”
Bristol-Myers Squibb Co. (NYSE:BMY): Closing price $43.69
Limited data from the first late-stage study of the immunotherapy drug Yervoy for patients with advanced prostate cancer who had previously received chemotherapy, indicate that the drug failed to significantly prolong survival. Yervoy (ipilimumab) allows the immune system to attack and kill cancer cells by blocking the action of a protein called CTLA-4. The closely-monitored drug was approved in 2011 to treat melanoma, which is the most deadly form of skin cancer, and is set to achieve yearly sales of $1 billion. An abstract, or limited summary, of findings from the prostate cancer study was issued on Thursday.
Raptor Pharmaceutical Corp. (NASDAQ:RPTP): Closing price $14.50
Raptor said Thursday that the European Commission has cleared Procysbi gastro-resistant hard capsules of cysteamine (as mercaptamine bitartrate) as an orphan medicinal product for the treatment of proven nephropathic cystinosis for marketing in the European Union. The approval of the marketing authorization application by the EC comes after the positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June. The orphan medicinal product designation allows a 10-year period of market exclusivity in the EU that begins from the notification date of the EC Decision granting the MAA.
Coronado Biosciences, Inc. (NASDAQ:CNDO): Closing price $8.25
Coronado announced Thursday that it has begun a National Institutes of Health-sponsored phase 2 study evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis. This multi-center evaluation will be conducted by the Autoimmunity Centers of Excellence, which are funded through a multi-million dollar grant from the National Institute of Allergy and Infectious Diseases, which forms part of the NIH. Coronado is a biopharmaceutical firm centered on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer.