Cubist Pharmaceuticals Inc. (NASDAQ:CBST) gained $3.69 to $72.24 on Friday after FDA approved an NDA for Cubist's Sivextro tedizolid to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by certain susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Sivextro is also under EMA review to treat complicated skin and soft tissue infections (cSSTIs).
Earlier in the week, FDA accepted and granted Priority Review to an NDA for ceftolozane/tazobactam to treat complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). The PDUFA date is Dec. 21. The company plans to submit an MAA to EMA next half.
Cubist was up $3.53 on the week.
EnteroMedics Inc. (NASDAQ:ETRM) rose $0.19 (12%) to $1.81 last week after FDA's Gastroenterology and Urology Devices Panel voted 6-2 that the relative benefits of the Maestro Rechargeable (RC) System outweigh the risks to treat obesity. The system - which is approved in Europe and Australia - comprises the implantation of two electrodes that deliver intermittent electrical impulses to the vagus nerve, which affects the perception of hunger and fullness.
Gilead Sciences Inc. (NASDAQ:GILD) was up $0.48 to $81.20 last week after the U.K.'s NICE issued draft guidance saying it is "minded not to recommend" Sovaldi sofosbuvir for chronic HCV infection, but needs more information on the product's cost effectiveness before it