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Pfizer Inc (PFE.N)

PFE.N on New York Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Calithera Biosciences Initiates Phase 1/2 Trial Of Telaglenastat
Tuesday, 2 Jul 2019 08:00am EDT 

July 2 (Reuters) - Calithera Biosciences Inc ::CALITHERA BIOSCIENCES INITIATES PHASE 1/2 TRIAL OF TELAGLENASTAT IN COMBINATION WITH PFIZER’S CDK4/6 INHIBITOR PALBOCICLIB.CALITHERA BIOSCIENCES - ANNOUNCED TREATMENT OF FIRST PATIENT IN PHASE 1/2 TRIAL OF GLUTAMINASE INHIBITOR TELAGLENASTAT WITH PFIZER'S IBRANCE.CALITHERA BIOSCIENCES INC - AS PART OF AGREEMENT, PFIZER IS PROVIDING PALBOCICLIB AND TALAZOPARIB, AS WELL AS FINANCIAL SUPPORT.  Full Article

Pfizer SAYS 2 Of 6 Patients Receiving DMD Gene Therapy Required Hospitalization
Friday, 28 Jun 2019 10:15am EDT 

June 28 (Reuters) - Pfizer Inc ::PFIZER PRESENTS INITIAL CLINICAL DATA ON PHASE 1B GENE THERAPY STUDY FOR DUCHENNE MUSCULAR DYSTROPHY.PFIZER SAYS DUCHENNE MUSCULAR DYSTROPHY GENE THERAPY LEADS TO MINI-DYSTROPHIN EXPRESSION LEVELS 10-60% OF NORMAL IN 6-PATIENT STUDY.PFIZER SAYS 2 OF 6 PATIENTS RECEIVING DMD GENE THERAPY REQUIRED HOSPITALIZATION.PFIZER INC - IN ACCORDANCE WITH ORIGINAL STUDY DESIGN, NO OTHER PARTICIPANTS WILL BE DOSED UNTIL SPECIFIC ADDITIONAL SAFETY MONITORING.  Full Article

Pfizer Receives U.S. FDA Approval For Its Oncology Biosimilar ZIRABEV
Friday, 28 Jun 2019 07:33am EDT 

June 28 (Reuters) - Pfizer Inc ::PFIZER RECEIVES U.S. FDA APPROVAL FOR ITS ONCOLOGY BIOSIMILAR, ZIRABEV™ (BEVACIZUMAB-BVZR).PFIZER INC - FDA APPROVAL WAS BASED ON REVIEW OF A COMPREHENSIVE DATA PACKAGE WHICH DEMONSTRATED BIOSIMILARITY OF ZIRABEV TO REFERENCE PRODUCT.  Full Article

Pfizer Responds To CDC's Vote To Revise The Recommendation For Routine Use Of Prevnar 13
Wednesday, 26 Jun 2019 03:57pm EDT 

June 26 (Reuters) - Pfizer Inc ::PFIZER INC. - PFIZER RESPONDS TO THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S VOTE TO REVISE THE RECOMMENDATION FOR ROUTINE USE OF PREVNAR 13® FOR THE PREVENTION OF PNEUMOCOCCAL DISEASE FOR ADULTS 65 YEARS OR OLDER.PFIZER SAYS "REVISED RECOMMENDATION REINFORCES THAT PREVNAR 13 IS CONSIDERED SAFE AND EFFECTIVE BY THE FDA AND ACIP".  Full Article

Pfizer says Europe Approves Talzenna For Patients With Locally Advanced Or Metastatic Breast Cancer
Friday, 21 Jun 2019 10:45am EDT 

June 21 (Reuters) - Pfizer Inc ::EUROPEAN COMMISSION APPROVES TALZENNA (TALAZOPARIB) FOR PATIENTS WITH INHERITED (GERMLINE) BRCA-MUTATED LOCALLY ADVANCED OR METASTATIC BREAST CANCER.PFIZER INC - ONLY ONCE-DAILY PARP INHIBITOR APPROVED IN EUROPE FOR HEREDITARY BREAST CANCER.  Full Article

Pfizer Inc Reports A Passive Stake Of 8.7% In Nextcure Inc As Of May 13, 2019
Wednesday, 22 May 2019 05:47pm EDT 

May 22 (Reuters) - NextCure Inc ::PFIZER INC REPORTS A PASSIVE STAKE OF 8.7% IN NEXTCURE INC AS OF MAY 13, 2019 - SEC FILING.  Full Article

Pfizer Confirms Initiation Of EU Review Of Tofacitinib With Interim Recommendations
Friday, 17 May 2019 11:33am EDT 

May 17 (Reuters) - Pfizer Inc ::PFIZER INC. - PFIZER CONFIRMS INITIATION OF EU REVIEW OF TOFACITINIB WITH INTERIM RECOMMENDATIONS.PFIZER INC - CONTINUES TO WORK WITH REGULATORY BODIES AND IS TAKING STEPS TO INFORM HEALTHCARE PROFESSIONALS IN EU/EEA ABOUT THIS INTERIM GUIDANCE.PFIZER INC - CONFIRMS THAT EMA ISSUED RECOMMENDATIONS LIMITING USE OF XELJANZ 10 MG TWICE DAILY IN SUBSET OF PATIENTS WITH ULCERATIVE COLITIS IN EU.PFIZER - RECOMMENDATIONS FROM EMA ARE TEMPORARY WHILE EMA'S COMMITTEE UNDERTAKES REVIEW OF ALL AVAILABLE EVIDENCE ON SAFETY, EFFICACY OF TOFACITINIB.PFIZER - REVIEW IS RESULT OF OBSERVATION OF INCREASED RISK OF PE WITH TOFACITINIB 10 MG TWICE DAILY IN ONGOING FDA POST-MARKETING REQUIREMENT STUDY.  Full Article

Pfizer's dermatitis treatment meets main goals of late-stage study
Wednesday, 15 May 2019 06:45am EDT 

May 15 (Reuters) - Pfizer Inc ::PFIZER ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF INVESTIGATIONAL ORAL JAK1 CANDIDATE, ABROCITINIB (PF-04965842), IN PATIENTS AGED 12 AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS.PFIZER- BY WEEK 12, PERCENT OF PATIENTS ACHIEVING CO-PRIMARY EFFICACY ENDPOINTS WITH EITHER DOSE WAS STATISTICALLY SIGNIFICANTLY HIGHER VERSUS PLACEBO .PFIZER- BY WEEK 12, PERCENT OF PATIENTS ACHIEVING EACH SECONDARY ENDPOINT WITH EITHER DOSE WAS STATISTICALLY SIGNIFICANTLY HIGHER VERSUS PLACEBO .PFIZER INC - STUDY ACHIEVES ALL CO-PRIMARY AND SECONDARY ENDPOINTS.PFIZER INC - RESULTS DEMONSTRATE RESPONSE TO TREATMENT FOR A STATISTICALLY SIGNIFICANT NUMBER OF PATIENTS.PFIZER INC - SAFETY RESULTS SHOW THAT BOTH DOSES OF ABROCITINIB WERE WELL-TOLERATED, AND THERE WERE NO UNEXPECTED SAFETY EVENTS.PFIZER - DISCONTINUATION RATES DUE TO AN ADVERSE EVENT WERE LOW IN EACH TREATMENT ARM (5.8% AND 5.8% IN 100MG AND 200MG) COMPARED TO PLACEBO (9.1%).  Full Article

Pfizer's Atopic Dermatitis Study Achieves All Co-Primary And Secondary Endpoints
Wednesday, 15 May 2019 06:45am EDT 

May 15 (Reuters) - Pfizer Inc ::PFIZER ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF INVESTIGATIONAL ORAL JAK1 CANDIDATE, ABROCITINIB (PF-04965842), IN PATIENTS AGED 12 AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS.PFIZER INC - STUDY ACHIEVES ALL CO-PRIMARY AND SECONDARY ENDPOINTS.PFIZER INC - TOP-LINE RESULTS SHOWED THAT BY WEEK 12 PERCENTAGE OF PATIENTS ACHIEVING EACH CO-PRIMARY EFFICACY ENDPOINT.PFIZER INC - SECONDARY ENDPOINT WITH EITHER DOSE OF ABROCITINIB WAS STATISTICALLY SIGNIFICANTLY HIGHER THAN PLACEBO.PFIZER INC - RESULTS DEMONSTRATE RESPONSE TO TREATMENT FOR A STATISTICALLY SIGNIFICANT NUMBER OF PATIENTS.PFIZER INC - SAFETY RESULTS SHOW BOTH DOSES OF ABROCITINIB WERE WELL-TOLERATED, AND THERE WERE NO UNEXPECTED SAFETY EVENTS.PFIZER INC - SAFETY RESULTS SHOW THAT BOTH DOSES OF ABROCITINIB WERE WELL-TOLERATED, AND THERE WERE NO UNEXPECTED SAFETY EVENTS.PFIZER - DISCONTINUATION RATES DUE TO AN ADVERSE EVENT WERE LOW IN EACH TREATMENT ARM (5.8% AND 5.8% IN 100MG AND 200MG) COMPARED TO PLACEBO (9.1%).  Full Article

Australian competition regulator Not To Oppose GSK's Proposed Acquisition Of Pfizer's Consumer Healthcare Business In Australia
Wednesday, 8 May 2019 08:56pm EDT 

May 9 (Reuters) - Australian Competition and Consumer Commission::WILL NOT OPPOSE GSK’S PROPOSED ACQUISITION OF PFIZER’S CONSUMER HEALTHCARE BUSINESS IN AUSTRALIA.ACCC CONSIDERS THAT TRANSACTION WILL NOT SUBSTANTIALLY LESSEN COMPETITION IN ANY MARKET IN AUSTRALIA.  Full Article

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Gilead invests $5 billion to deepen ties with biotech Galapagos

U.S. antiviral drugmaker Gilead Sciences will invest $5.1 billion in a major expansion of its partnership with Belgo-Dutch biotech Galapagos NV , news that lifted Galapagos's shares more than 18% to an all-time high on Monday.