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News Breaks
June 19, 2014
16:33 EDTCBSTCubist announces acceptance of Ceftolozane/Tazobactam NDA Priority Review
Cubist Pharmaceuticals announced that the FDA has accepted the companys New Drug Application, or NDA, for its investigational antibiotic ceftolozane/tazobactam with Priority Review. The FDA has assigned a Prescription Drug User Fee Act action date of December 21. Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. The NDA is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the FDA and the European Medicines Agency specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials ceftolozane/tazobactam demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae in patients with complicated infections.
News For CBST From The Last 14 Days
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July 23, 2014
10:02 EDTCBSTOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: 21st Century Fox (FOXA) downgraded to Market Perform from Outperform at Cowen... Brinker (EAT) downgraded to Sector Perform from Outperform at RBC Capital... Cubist (CBST) downgraded to Market Perform from Outperform at JMP Securities... DiamondRock (DRH) downgraded to Neutral from Outperform at RW Baird... DuPont (DD) downgraded to Neutral from Overweight at JPMorgan... FirstMerit (FMER) downgraded to Neutral from Overweight at JPMorgan... Helmerich & Payne (HP) downgraded to Accumulate from Buy at Tudor Pickering... Hexcel (HXL) downgraded to Hold from Buy at Canaccord... Juniper (JNPR) downgraded to Neutral from Buy at BofA/Merrill... King Digital (KING) downgraded at BofA/Merrill... Lexmark (LXK) downgraded at Raymond James... McDonald's (MCD) downgraded at RW Baird... Mead Johnson (MJN) downgraded to Outperform from Buy at CLSA... National Oilwell (NOV) downgraded to Accumulate from Buy at Tudor Pickering... Nintendo (NTDOY) downgraded to Hold from Buy at Jefferies... Raytheon (RTN) downgraded to Market Perform from Outperform at Bernstein... Targa Resources (TRGP) downgraded to Accumulate from Buy at Global Hunter... Time Warner (TWX) downgraded to Market Perform from Outperform at Cowen... Timmins Gold (TGD) downgraded to Market Perform from Outperform at Cowen... United Technologies (UTX) downgraded to Market Perform from Outperform at Wells Fargo... Viacom (VIAB) downgraded to Market Perform from Outperform at Cowen... Xilinx (XLNX) downgraded at BMO Capital.
06:05 EDTCBSTCubist downgraded to Market Perform from Outperform at JMP Securities
JMP Securities downgraded Cubist citing the Q2 miss and slowing growth.
July 22, 2014
17:13 EDTCBSTCubist sees FY14 revenue toward low end of previous range
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16:01 EDTCBSTCubist reports Q2 EPS 23c, may not compare to consensus 2c
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