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News Breaks
December 6, 2012
16:02 EDTCBSTFDA grants QIDP designation to two Cubist Phase 3 antibiotic candidates
Cubist Pharmaceuticals announced that the FDA has designated two of the company's Phase 3 antibiotic candidates, CXA-201 and CB-315, as Qualified Infectious Disease Products, or QIDP. The QIDP designations will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. CXA-201 is currently being studied in pivotal Phase 3 trials as a first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa. The FDA's QIDP designation applies to CXA-201's treatment of complicated intra-abdominal infections. CB-315 is currently being investigated in Phase 3 trials as an oral therapy for Clostridium difficile-associated diarrhea, or CDAD.
News For CBST From The Last 14 Days
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October 22, 2014
07:54 EDTCBSTCubist could still become part of larger organization over time, says UBS
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October 21, 2014
17:13 EDTCBSTCubist sees FY14 revenue $1.19M-$1.28M, consensus $1.2B
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16:01 EDTCBSTCubist reports Q3 EPS 58c, may not compare to consensus 4c
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15:30 EDTCBSTNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Yahoo! (YHOO), consensus 30c; ACE (ACE), consensus $2.34; Discover Financial (DFS), consensus $1.34; Pinnacle Financial (PNFP), consensus 51c; Broadcom (BRCM), consensus 84c; Intuitive Surgical (ISRG), consensus $3.80; FMC Technologies (FTI), consensus 74c; Robert Half International (RHI), consensus 58c; E-Trade (ETFC), consensus 22c; Nabors Industries (NBR), consensus 36c; Waste Connections (WCN), consensus 54c; Cubist Pharmaceuticals (CBST), consensus 4c; Sonic (SONC), consensus 34c; American Campus Communities (ACC), consensus 43c; Cree (CREE), consensus 36c; Fulton Financial (FULT), consensus 20c; Costamare (CMRE), consensus 41c; Hawaiian Holdings (HA), consensus 78c; Ethan Allen (ETH), consensus 36c; Sabra Health (SBRA), consensus 55c; Rush Enterprises (RUSHA), consensus 51c.
October 20, 2014
09:22 EDTCBSTOn The Fly: Pre-market Movers
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07:32 EDTCBSTCubist names Perez CEO to succeed Bonney
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07:30 EDTCBSTCubist names Perez CEO
06:56 EDTCBSTShire reopens acquistion talks with NPS Pharmaceuticals, Cubist, Telegraph says
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October 14, 2014
11:23 EDTCBSTBIND Therapeutics and The Conference Forum hold a conference
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