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- Cubist Pharmaceuticals, Inc. Q1 2009 Earnings Call Transcript
- Question-and-Answer SessionOperator Thank you. Operator instructions Our first question comes from the line of Ian Sanderson with Cowen. Please proceed with your question. Ian Sanderson – Cowen Good afternoon. Thanks for taking the question. Can you give us a little bit more detail, perhaps others know this but I...
- Earnings calls 2009-04-21
Additional Resources
- Pivotal Phase 3 Cubicin Data Presented at ICAAC Late Breaker Session; Landmark Study Finds CUBICIN Comparable to Dual Therapy Standard of Care for the Treatment of Staph Infections of the Bloodstream and Heart
- WASHINGTON -- Today at the Interscience Conference on Antimicrobial Agents and Chemotherapy ICAAC results were presented from the CUBICINR daptomycin for injection Phase 3 multicenter (246 patients - US: 206; Europe: 40), randomized, open-label study of the safety and efficacy of CUBICIN compared to conventional therapy for the treatment of...
- Research articles 2005-12-16
- Cubist Pharmaceuticals Licenses Rights for Development and Commercialization of CUBICIN in Japan to Merck & Co., Inc
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has entered into a license agreement with Merck & Co., Inc. for the development and commercialization of CUBICIN[R] daptomycin for injection in Japan. Merck will develop and commercialize CUBICIN through its wholly-owned subsidiary, Banyu Pharmaceutical Co., Ltd. With...
- Research articles 2007-03-22
- Review of Cubist Pharmaceuticals sNDA for CUBICIN Moves Forward at FDA; Anti-infective Drugs Advisory Committee to meet March 6
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that the supplemental New Drug Application sNDA to expand the indication for CUBICINR daptomycin for injection as therapy for the treatment of patients with bacteremia with known or suspected endocarditis caused by Staphylococcus aureus (S. aureus) will be the focus...
- Research articles 2006-01-23
- Positive Opinion For CUBICIN® Received from European Regulatory Authority; Final EU Approval of Antibiotic Expected in the First Quarter of 2006
- EMERYVILLE, Calif. & LEXINGTON, Mass. -- Chiron Corporation (Nasdaq:CHIR) and Cubist Pharmaceuticals Inc. (Nasdaq:CBST) today announced that the Committee for Medicinal Products for Human Use CHMP, the scientific committee of the European Medicines Agency EMEA, has issued a positive opinion recommending approval of Chiron's Marketing Authorization Application MAA for CUBICINR...
- Research articles 2005-11-17
- Cubist Pharmaceuticals Files sNDA to Expand CUBICIN® Label for Staphylococcus Aureus Bacteremia With Known or Suspected Endocarditis; Company Requests Priority Review
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced the submission to the U.S. Food & Drug Administration FDA of a Supplemental New Drug Application sNDA for its IV antibiotic CUBICINR daptomycin for injection requesting approval for a new indication at 6 mg/kg for treatment of patients with bacteremia...
- Research articles 2005-09-26
- FDA Accepts CUBICIN® sNDA and Grants Priority Review
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that it has received notice from the U.S. Food & Drug Administration FDA that the Supplemental New Drug Application sNDA for Cubist's antibiotic CUBICINR daptomycin for injection has been accepted and has been granted priority review status. The FDA grants...
- Research articles 2005-11-21
- Cubist Pharmaceuticals' CUBICIN Approved for Additional Indications in the EU
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) said today that its IV antibiotic CUBICIN[R]daptomycin for injection is now approved for additional indications in the EU. These remarks were made by Michael W. Bonney, Cubist's President and CEO, during a web cast at the Thomas Weisel Partners Healthcare Conference in...
- Research articles 2007-09-06
- Cubist Pharmaceuticals Reports Positive Outcome from FDA Anti-Infective Drugs Advisory Committee; PDUFA Date for FDA Review of CUBICIN sNDA is March 24th
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today reported that the Anti-Infective Drugs Advisory Committee AIDAC voted that there was substantial evidence of safety and efficacy of CUBICINR daptomycin for injection in the treatment of S. aureus bacteremia and infective endocarditis. The data reviewed today were based on the...
- Research articles 2006-03-07
- Chiron and Cubist Pharmaceuticals Announce the Filing for EU Regulatory Approval to Market Cubicin -Daptomycin for Injection-
- EMERYVILLE, Calif. & LEXINGTON, Mass. -- Filing Moves CUBICIN Closer to EU Commercialization
- Research articles 2004-12-02
- Cubist Pharmaceuticals Announces the Completion of Patient Enrollment in Cubicin's Phase 3 Endocarditis/Bacteremia Trial
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST), following consultation with the U.S. Food and Drug Administration FDA, today announced that it has completed enrollment of patients in its international Phase 3 clinical trial of CubicinR daptomycin for injection for the treatment of infective endocarditis and bacteremia caused by Staphylococcus...
- Research articles 2004-11-09
- CUBICIN Meets Primary Endpoints in Ground-Breaking Staphylococcus Aureus Endocarditis/Bacteremia Study; Cubist Plans to File sNDA for Expanded Label Before Year-end
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that its Phase 3 Staphylococcus aureus (S. aureus) endocarditis and bacteremia trial of CUBICINR daptomycin for injection at 6 mg/kg once daily met its primary endpoints of non-inferiority in the intent-to-treat ITT and per protocol PP populations. Cubist expects to...
- Research articles 2005-06-27
- Cubist Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee Meeting to Discuss CUBICIN® sNDA
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that NASDAQ has halted trading of Cubist common stock. The Anti-Infective Drug Advisory Committee to the U.S. Food and Drug Administration FDA meets today to review and discuss the Supplemental New Drug Application sNDA for CUBICINR daptomycin for injection seeking...
- Research articles 2006-03-06
- Cubist Pharmaceuticals Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee Meeting; AIDAC Meeting to Review CUBICIN sNDA is Monday, March 6th
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that briefing documents prepared by Cubist and the FDA and provided to members of the Anti-Infective Drugs Advisory Committee AIDAC are now available to the public. The documents posted on line today by the FDA refer to the sNDA filed...
- Research articles 2006-03-03
- The New England Journal of Medicine Publishes Results of Cubist's Landmark Study of Staphylococcus Aureus Blood Stream Infections; Study Results Led to Recent Label Expansion for CUBICIN
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that the New England Journal of Medicine NEJM has published results from the company's landmark Phase 3 study of CUBICINR daptomycin for injection at 6 mg/kg as monotherapy vs. dual therapy standard of care for the treatment of patients with...
- Research articles 2006-08-16
- Cubist Pharmaceuticals Has Submitted Response to FDA Approvable Letter Received on Friday; FDA Action Anticipated by Late May
- LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that the Company has submitted to the Food & Drug Administration FDA an amendment to the sNDA for CUBICINR daptomycin for injection, in complete response to the FDA Approvable Letter of March 24, 2006. The sNDA seeks a label expansion...
- Research articles 2006-03-27
- Cubist Pharmaceuticals Inc. Q4 2008 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Our first question is from the line of Rachael McMinn with Cowen & Company. Please state your question. Rachael McMinn - Cowen & Company Thanks very much. I guess some longer term vision questions, as well as near-term questions. When you give your peak sales...
- Earnings calls 2009-01-22
- Cubist Pharmaceuticals Inc. Q3 2008 Earnings Call Transcript
- Question-and-Answer SessionOperator Thank you. Operator Instructions. First question is from Tom Shrader with Rodman & Renshaw. Please go ahead with your question. Tom Shrader - Rodman & Renshaw Good afternoon. Mike Bonney Hi, Tom. Tom Shrader - Rodman & Renshaw I have a question. The revenue numbers are quite...
- Earnings calls 2008-10-16
- What We Like About Cubist Pharma
- Andrew Horowitz submits: We are carefully entering portfolio positions in this environment. (Note: Portfolio positions vs. trading positions) A company that we like for its specialty product is Cubist Pharmaceuticals CBST. It has made all of our screens recently, but we were reluctant to add it to portfolios as the...
- External links 2009-11-05
- Cubist Pharmaceuticals and Chiron Corporation Announce Plans to File for European Regulatory Approval of Cubicin —Daptomycin for Injection— by Year-End 2004
- Business Editors/Health/Medical Writers
- Research articles 2004-06-07
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