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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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November 20, 2014
10:02 EDTCBSTOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Zoetis (ZTS) downgraded to Market Perform from Outperform at William Blair... Target (TGT) downgraded to Hold from Buy at Evercore ISI... Alexandria Real Estate (ARE) downgraded to Neutral from Outperform at RW Baird... Allscripts (MDRX) downgraded to Sector Perform from Outperform at RBC Capital... athenahealth (ATHN) downgraded to Underperform from Sector Perform at RBC Capital... Boston Properties (BXP) downgraded to Neutral from Outperform at RW Baird... Cliffs Natural (CLF) downgraded to Hold from Buy at Deutsche Bank... Cubist (CBST) downgraded to Neutral from Outperform at Credit Suisse... Denbury Resources (DNR) downgraded to Equal Weight from Overweight at Barclays... E-House (EJ) downgraded to Perform from Outperform at Oppenheimer... Owens-Illinois (OI) downgraded to Market Perform from Outperform at BMO Capital... Quality Systems (QSII) downgraded to Sector Perform from Outperform at RBC Capital... Sapient (SAPE) downgraded to Hold from Buy at Stifel... Harsco (HSC) downgraded to Hold from Buy at Argus... Credit Acceptance (CACC) downgraded to Underperform from Market Perform at JMP Securities... Liberty Media (LMCA) downgraded to Hold from Buy at Telsey Advisory.
07:43 EDTCBSTCubist downgraded at Credit Suisse
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06:06 EDTCBSTCubist downgraded to Neutral from Outperform at Credit Suisse
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November 17, 2014
07:16 EDTCBSTMilken Institute--Faster Cures to hold a conference
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05:16 EDTCBSTCubist to invest about $400M in antibiotics R&D in 2014
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