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Bristol-Myers Squibb Co (BMY.N)

BMY.N on New York Stock Exchange

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16 Oct 2018
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Latest Key Developments (Source: Significant Developments)

Bristol-Myers Says BMS-986165 Delivered Significant Skin Clearance In Phase 2 Trial
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - Bristol-Myers Squibb Co ::BRISTOL-MYERS SQUIBB SAYS ANNOUNCED RESULTS FROM PHASE 2 STUDY OF BMS-986165, A TYK2 INHIBITOR, IN PATIENTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS.BRISTOL-MYERS SAYS BMS-986165 DELIVERED SIGNIFICANT SKIN CLEARANCE IN PATIENTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS IN PHASE 2 TRIAL.BRISTOL-MYERS SAYS EFFICACY ENDPOINTS IN PHASE 2 STUDY OF BMS-986165 WERE ACHIEVED AFTER 12 WEEKS OF TREATMENT WITH ≥3 MG DAILY OF BMS-986165.  Full Article

Replimune Announces FDA Acceptance Of Application For Lead Oncolytic Immunotherapy Rp1
Thursday, 6 Sep 2018 

Sept 6 (Reuters) - Replimune Group Inc ::REPLIMUNE ANNOUNCES FDA ACCEPTANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR ITS LEAD ONCOLYTIC IMMUNOTHERAPY CANDIDATE, RP1.REPLIMUNE GROUP INC - INTENDS TO OPEN ITS ONGOING PHASE 1/2 CLINICAL TRIAL IN U.S. AND BEGIN ENROLLING PATIENTS IN Q4.REPLIMUNE - IN PART 1 OF PHASE 1/2 TRIAL, CO IS ASSESSING SAFETY AND TOLERABILITY OF RP1 ADMINISTERED ALONE IN PATIENTS WITH ADVANCED SOLID TUMORS.REPLIMUNE GROUP - PART TWO OF PHASE 1/2 CLINICAL TRIAL FOR RP1 EXPECTED TO INITIATE IN FIRST HALF OF 2019.REPLIMUNE - PART 2 OF PHASE 1/2 TRIAL IS EXPECTED TO BE INITIATED IN H1 2019.REPLIMUNE GROUP - IN PART TWO OF PHASE 1/2 CLINICAL TRIAL CO INTENDS TO STUDY SAFETY & EFFICACY OF RP1 IN COMBINATION WITH NIVOLUMAB.  Full Article

U.S. Food And Drug Administration Accepts Bristol-Myers Squibb’S Application For Sprycel
Thursday, 30 Aug 2018 

Aug 30 (Reuters) - Bristol-Myers Squibb Co ::U.S. FOOD AND DRUG ADMINISTRATION ACCEPTS BRISTOL-MYERS SQUIBB’S APPLICATION FOR SPRYCEL (DASATINIB) IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA.BRISTOL-MYERS SQUIBB CO - APPLICATION BASED ON RESULTS FROM PHASE 2 CA180-372 STUDY.BRISTOL-MYERS SQUIBB CO - FDA ACTION DATE IS DECEMBER 29, 2018.BRISTOL-MYERS SQUIBB CO - FDA ACTION DATE IS DECEMBER 29, 2018..  Full Article

Bristol-Myers Squibb Appoints Chief Commercial Officer
Tuesday, 28 Aug 2018 

Aug 28 (Reuters) - Bristol-Myers Squibb Co ::BRISTOL-MYERS SQUIBB APPOINTS CHRISTOPHER BOERNER EXECUTIVE VICE PRESIDENT AND CHIEF COMMERCIAL OFFICER.BRISTOL-MYERS SQUIBB - BOERNER SUCCEEDS MURDO GORDON, WHO DEPARTED CO ON AUGUST 3, 2018.  Full Article

U.S. FDA Accepts For Priority Review Bristol-Myers Squibb's Application For Empliciti
Thursday, 23 Aug 2018 

Aug 23 (Reuters) - Bristol-Myers Squibb Co ::U.S. FOOD AND DRUG ADMINISTRATION ACCEPTS FOR PRIORITY REVIEW BRISTOL-MYERS SQUIBB’S APPLICATION FOR EMPLICITI (ELOTUZUMAB) PLUS POMALIDOMIDE AND LOW-DOSE DEXAMETHASONE IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA.BRISTOL-MYERS SQUIBB CO - FDA GRANTED APPLICATION PRIORITY REVIEW WITH AN ACTION DATE OF DECEMBER 27, 2018.  Full Article

European Commission Approves Bristol-Myers Squibb's Opdivo
Tuesday, 31 Jul 2018 

July 31 (Reuters) - Bristol-Myers Squibb Co ::EUROPEAN COMMISSION APPROVES BRISTOL-MYERS SQUIBB’S OPDIVO (NIVOLUMAB) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH MELANOMA WITH INVOLVEMENT OF LYMPH NODES OR METASTATIC DISEASE WHO HAVE UNDERGONE COMPLETE RESECTION.BRISTOL-MYERS - EU APPROVAL IS BASED ON RESULTS FROM ONGOING PHASE 3 RANDOMIZED DOUBLE-BLIND CHECKMATE -238 TRIAL.  Full Article

Bristol-Myers Squibb Reports Quarterly GAAP EPS $0.23
Thursday, 26 Jul 2018 

July 26 (Reuters) - Bristol-Myers Squibb Co ::BRISTOL-MYERS SQUIBB - QTRLY GAAP EPS $0.23; QTRLY NON-GAAP EPS $1.01.BRISTOL-MYERS SQUIBB - QTRLY REVENUE UP 11 PERCENT TO $5.7 BILLION.BRISTOL-MYERS SQUIBB - DECREASING 2018 GAAP EPS OUTLOOK RANGE TO $2.68-$2.78 FROM $2.70-$2.80.BRISTOL-MYERS SQUIBB - INCREASING 2018 NON-GAAP EPS GUIDANCE RANGE TO $3.55-$3.65 FROM $3.35-$3.45.BRISTOL-MYERS SQUIBB - SEES 2018 WORLDWIDE REVENUES INCREASING IN MID- TO HIGH-SINGLE DIGITS.BRISTOL-MYERS SQUIBB - QTRLY WORLDWIDE OPDIVO REVENUE $1,627 MILLION VERSUS $1,195 MILLION.BRISTOL-MYERS SQUIBB - QTRLY ELIQUIS WORLDWIDE REVENUE $1,650 MILLION VERSUS $1,176 MILLION.Q2 EARNINGS PER SHARE VIEW $0.87, REVENUE VIEW $5.49 BILLION -- THOMSON REUTERS I/B/E/S.FY2018 EARNINGS PER SHARE VIEW $3.42, REVENUE VIEW $21.78 BILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Bristol-Myers Squibb Says Opdivo + Yervoy Now Approved In 3 Tumor Types
Wednesday, 11 Jul 2018 

July 11 (Reuters) - Bristol-Myers Squibb Co ::BRISTOL-MYERS SQUIBB’S OPDIVO® (NIVOLUMAB) + LOW-DOSE YERVOY® (IPILIMUMAB) IS THE FIRST IMMUNO-ONCOLOGY COMBINATION APPROVED FOR MSI-H/DMMR MCRC PATIENTS WHO PROGRESSED FOLLOWING TREATMENT WITH A FLUOROPYRIMIDINE, OXALIPLATIN AND....BRISTOL-MYERS SQUIBB CO - IN CHECKMATE -142 TRIAL, OPDIVO + YERVOY DEMONSTRATED AN OVERALL RESPONSE RATE OF 46%.BRISTOL-MYERS SQUIBB - OPDIVO + YERVOY IS NOW APPROVED IN THREE TUMOR TYPES, DOSING AND ADMINISTRATION VARIES BY TUMOR.BRISTOL-MYERS SQUIBB CO - OPDIVO + YERVOY IS ASSOCIATED WITH WARNINGS AND PRECAUTIONS SUCH AS IMMUNE-MEDIATED PNEUMONITIS, COLITIS, HEPATITIS.BRISTOL-MYERS SQUIBB - OPDIVO + YERVOY IS ALSO ASSOCIATED WITH WARNINGS & PRECAUTIONS LIKE ENDOCRINOPATHIES, NEPHRITIS & RENAL DYSFUNCTION, SKIN ADVERSE REACTIONS.BRISTOL-MYERS SQUIBB - OPDIVO + YERVOY IS ALSO ASSOCIATED WITH WARNINGS & PRECAUTIONS LIKE ENCEPHALITIS, OTHER ADVERSE REACTIONS; INFUSION REACTIONS.BRISTOL-MYERS SQUIBB CO - YERVOY CAN RESULT IN SEVERE AND FATAL IMMUNE-MEDIATED ADVERSE REACTIONS.  Full Article

Exalenz Bioscience's Non-Invasive Breathid Test To Be Evaluated In Two Bristol-Myers Squibb Phase 2B Clinical Trials In Adult Patients With Nash
Tuesday, 10 Jul 2018 

July 10 (Reuters) - Exalenz Bioscience Ltd ::EXALENZ BIOSCIENCE’S NON-INVASIVE BREATHID® TEST TO BE EVALUATED IN TWO BRISTOL-MYERS SQUIBB PHASE 2B CLINICAL TRIALS IN ADULT PATIENTS WITH NASH.EXALENZ BIOSCIENCE LTD - BREATHID (13)C-METHACETIN BREATH TEST WILL BE EVALUATED IN TWO PHASE 2B CLINICAL STUDIES SPONSORED BY BRISTOL-MYERS SQUIBB.  Full Article

European Commission Approves Expanded Indication For Sprycel
Thursday, 5 Jul 2018 

July 5 (Reuters) - Bristol-Myers Squibb Co ::EUROPEAN COMMISSION APPROVES EXPANDED INDICATION FOR SPRYCEL (DASATINIB) TO INCLUDE TREATMENT OF CHILDREN WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE.BRISTOL-MYERS SQUIBB CO - EC APPROVAL IS BASED ON DATA FROM CA180-226 TRIAL.  Full Article

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