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Pfizer Inc (PFE)

PFE on New York Consolidated

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22 Apr 2019
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Latest Key Developments (Source: Significant Developments)

Pfizer Acquires 15 Pct Ownership Stake In Vivet
Wednesday, 20 Mar 2019 06:45am EDT 

March 20 (Reuters) - Pfizer Inc ::PFIZER SECURES EXCLUSIVE OPTION TO ACQUIRE GENE THERAPY COMPANY VIVET THERAPEUTICS.PFIZER INC - PFIZER ACQUIRES 15% OWNERSHIP STAKE IN VIVET.PFIZER INC - PFIZER AND VIVET TO COLLABORATE ON DEVELOPMENT OF POTENTIAL BREAKTHROUGH THERAPY FOR WILSON DISEASE.PFIZER INC - PFIZER PAID APPROXIMATELY EUR 45 MILLION (US$51 MILLION) UPON SIGNING OF DEAL.PFIZER INC - MAY PAY UP TO EUR 560 MILLION (US$635.8 MILLION) INCLUSIVE OF OPTION EXERCISE PAYMENT.PFIZER INC - CAN EXERCISE OPTION TO ACQUIRE 100% OF VIVET FOLLOWING COMPANY'S DELIVERY OF CERTAIN DATA FROM PHASE I/II CLINICAL TRIAL FOR VTX-801.PFIZER INC - PFIZER SENIOR EXECUTIVE MONIKA VNUK, M.D., VICE PRESIDENT, WORLDWIDE BUSINESS DEVELOPMENT, WILL JOIN VIVET'S BOARD OF DIRECTORS.PFIZER INC - OTHER TERMS OF TRANSACTION WERE NOT DISCLOSED.PFIZER INC - SECURED AN EXCLUSIVE OPTION TO ACQUIRE ALL OUTSTANDING SHARES.  Full Article

FDA Approves Pfizer's Trazimera With Certain Warnings
Monday, 11 Mar 2019 06:01pm EDT 

March 11 (Reuters) - FDA ::FDA- PFIZER'S TRAZIMERA APPROVED WITH WARNING OF CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, PULMONARY TOXICITY .  Full Article

Pfizer Receives European Approval For Zirabev, A Biosimilar To Avastin
Tuesday, 19 Feb 2019 09:32am EST 

Feb 19 (Reuters) - Pfizer Inc ::PFIZER RECEIVES EUROPEAN APPROVAL FOR ZIRABEV (BEVACIZUMAB), A BIOSIMILAR TO AVASTIN.EC APPROVAL FOR ZIRABEV IS BASED ON A COMPREHENSIVE SUBMISSION PACKAGE WHICH DEMONSTRATED BIOSIMILARITY OF ZIRABEV AND ORIGINATOR PRODUCT.  Full Article

Gliknik To Receive $15 Mln Milestone Payment From Pfizer Inc Following Clinical Progress With PF-06755347
Tuesday, 19 Feb 2019 08:30am EST 

Feb 19 (Reuters) - Pfizer Inc ::GLIKNIK TO RECEIVE $15 MILLION MILESTONE PAYMENT FROM PFIZER INC. FOLLOWING CLINICAL PROGRESS WITH PF-06755347, PREVIOUSLY KNOWN AS GL-2045.  Full Article

Pfizer says FDA Accepts sBLA and Grants Priority Review for AVENCIO Plus INLYTA
Monday, 11 Feb 2019 05:44pm EST 

Feb 11 (Reuters) - Pfizer Inc ::FDA ACCEPTS SBLA AND GRANTS PRIORITY REVIEW FOR BAVENCIO® (AVELUMAB) PLUS INLYTA® (AXITINIB) FOR THE TREATMENT OF ADVANCED RENAL CELL CARCINOMA.PFIZER INC - APPLICATION HAS BEEN GIVEN A TARGET ACTION DATE IN JUNE 2019..PFIZER - EMD SERONO AND CO ANNOUNCE U.S. FDA ACCEPTED FOR PRIORITY REVIEW SBLA FOR BAVENCIO (AVELUMAB) IN COMBINATION WITH INLYTA.  Full Article

Pfizer Says Xtandi (Enzalutamide) Plus Androgen Deprivation Therapy (Adt) Met Primary Endpoint
Monday, 11 Feb 2019 05:00pm EST 

Feb 11 (Reuters) - Astellas Pharma Inc <4503.T>::PHASE 3 ARCHES TRIAL SHOWS XTANDI® (ENZALUTAMIDE) SIGNIFICANTLY IMPROVED RADIOGRAPHIC PROGRESSION-FREE SURVIVAL IN MEN WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER.PFIZER INC - XTANDI (ENZALUTAMIDE) PLUS ANDROGEN DEPRIVATION THERAPY (ADT) MET PRIMARY ENDPOINT.PFIZER INC - SECONDARY ENDPOINTS REPORTED SHOWED THAT XTANDI PLUS ADT REDUCED RISK OF PSA PROGRESSION.PFIZER INC - SECONDARY ENDPOINTS REPORTED SHOWED THAT XTANDI PLUS ADT REDUCED RISK OF STARTING A NEW ANTINEOPLASTIC THERAPY COMPARED TO ADT ALONE.  Full Article

Pfizer Says FDA Accepts Submissions For Review Of Tafamidis
Monday, 14 Jan 2019 08:00am EST 

Jan 14 (Reuters) - Pfizer Inc ::US FDA ACCEPTS REGULATORY SUBMISSIONS FOR REVIEW OF TAFAMIDIS TO TREAT TRANSTHYRETIN AMYLOID CARDIOMYOPATHY.PFIZER INC - TARGET PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE FOR A DECISION BY FDA IS IN JULY 2019.PFIZER INC - FDA GRANTS A PRIORITY REVIEW BASED ON PHASE 3 ATTR-ACT STUDY FINDINGS IN ATTR-CM.  Full Article

UK's CMA Not To Refer Baxter-Hospira Deal To Phase II Probe
Friday, 4 Jan 2019 06:00am EST 

Jan 4 (Reuters) - UK's CMA::UK'S CMA- CMA HAS DECIDED NOT TO REFER ACQUISITION BY BAXTER INTERNATIONAL. OF HOSPIRA UKS COMPOUNDING BUSINESS AND RELATED ASSETS. TO PHASE II.  Full Article

Merck KGaA And Pfizer Provide Update On Javelin Ovarian 100 Trial Of Avelumab
Friday, 21 Dec 2018 02:00pm EST 

Dec 21 (Reuters) - Pfizer Inc ::MERCK KGAA, DARMSTADT, GERMANY, AND PFIZER PROVIDE UPDATE ON JAVELIN OVARIAN 100 TRIAL OF AVELUMAB IN PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER.PFIZER - INTERIM ANALYSIS OF PHASE III JAVELIN STUDY DID NOT SUPPORT STUDY'S INITIAL HYPOTHESIS.PFIZER INC - ALLIANCE HAS NOTIFIED HEALTH AUTHORITIES AND TRIAL INVESTIGATORS OF INTERIM FINDINGS AND DECISION TO DISCONTINUE TRIAL.PFIZER INC - RESULTS SHOWED THAT STUDY WOULD NOT ACHIEVE SUPERIORITY IN PRE-SPECIFIED PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL.PFIZER INC - WHILE DETAILED ANALYSES OF DATA ARE ONGOING, NO NEW SAFETY SIGNALS WERE OBSERVED IN STUDY.PFIZER INC - SAFETY PROFILE FOR AVELUMAB IN THE TRIAL APPEARS CONSISTENT WITH THAT OBSERVED IN OVERALL JAVELIN CLINICAL DEVELOPMENT PROGRAM.  Full Article

Independent data monitoring committee recommends discontinuation of the phase 2b strive clinical trial of staphylococcus aureus vaccine following planned interim analysis
Thursday, 20 Dec 2018 04:30pm EST 

Dec 20 (Reuters) - Pfizer Inc ::INDEPENDENT DATA MONITORING COMMITTEE RECOMMENDS DISCONTINUATION OF THE PHASE 2B STRIVE CLINICAL TRIAL OF STAPHYLOCOCCUS AUREUS VACCINE FOLLOWING PLANNED INTERIM ANALYSIS.INDEPENDENT DATA MONITORING COMMITTEE RECOMMENDS DISCONTINUATION OF THE PHASE 2B STRIVE CLINICAL TRIAL OF STAPHYLOCOCCUS AUREUS VACCINE FOLLOWING PLANNED INTERIM ANALYSIS.PFIZER - DMC CONCLUDED STUDY REACHED FUTILITY.PFIZER INC - SAFETY REVIEW BY DMC INDICATED THAT INVESTIGATIONAL VACCINE HAS BEEN SAFE AND WELL TOLERATED.PFIZER INC - STRIVE TRIAL PARTICIPANTS WHO ARE ENROLLED IN STUDY WILL COMPLETE STUDY'S FOLLOW-UP EVALUATIONS.PFIZER INC - EVALUATING NEXT STEPS FOR POTENTIAL DEVELOPMENT OF A S. AUREUS VACCINE.  Full Article

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Merck's Keytruda wins FDA approval as combination therapy for kidney cancer

The U.S. Food and Drug Administration has approved Merck & Co Inc's cancer therapy, Keytruda, as part of a combination therapy for previously untreated patients with the most common type of kidney cancer, the company said on Monday.