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Johnson & Johnson (JNJ.N)

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Latest Key Developments (Source: Significant Developments)

J&J Prepares To Resume Phase 3 Ensemble Trial Of Janssen Covid-19 Vaccine Candidate In U.S.
1:40am IST 

Oct 23 (Reuters) - Johnson & Johnson ::JOHNSON & JOHNSON PREPARES TO RESUME PHASE 3 ENSEMBLE TRIAL OF ITS JANSSEN COVID-19 VACCINE CANDIDATE IN THE U.S..J&J - INDEPENDENT DATA SAFETY AND MONITORING BOARD (DSMB) OVERSEEING ENSEMBLE STUDY HAS RECOMMENDED RESUMING TRIAL RECRUITMENT.J&J - PREPARATIONS TO RESUME TRIAL IN UNITED STATES, INCLUDING SUBMISSIONS FOR APPROVAL BY INSTITUTIONAL REVIEW BOARDS, ARE NOW UNDERWAY.J&J - DISCUSSIONS WITH OTHER REGULATORS AROUND WORLD TO RESUME CLINICAL TRIAL PROGRAM ARE PROGRESSING.J&J - DISCUSSIONS WITH OTHER REGULATORS AROUND THE WORLD TO RESUME THE CLINICAL TRIAL PROGRAM ARE PROGRESSING.J&J - AFTER A THOROUGH EVALUATION OF A SERIOUS MEDICAL EVENT EXPERIENCED BY ONE STUDY PARTICIPANT, NO CLEAR CAUSE HAS BEEN IDENTIFIED.J&J - THE COMPANY HAS FOUND NO EVIDENCE THAT THE VACCINE CANDIDATE CAUSED THE MEDICAL EVENT.J&J - IN ACCORDANCE WITH CLINICAL TRIAL PROTOCOL & REGULATORY REQUIREMENTS, JANSSEN STUDY TEAM REMAINS BLINDED.  Full Article

Genmab Announces IFM, Hovon And Janssen Achieve Positive Topline Results In Second Part Of Phase 3 Cassiopeia Study Of Daratumumab In Multiple Myeloma At Pre-Planned Interim Analysis
Thursday, 22 Oct 2020 

Oct 21 (Reuters) - Genmab A/S ::REG-GENMAB ANNOUNCES IFM, HOVON AND JANSSEN ACHIEVE POSITIVE TOPLINE RESULTS IN SECOND PART OF PHASE 3 CASSIOPEIA STUDY OF DARATUMUMAB IN MULTIPLE MYELOMA AT PRE-PLANNED INTERIM ANALYSIS.INDEPENDENT DATA MONITORING COMMITTEE RECOMMENDS UNBLINDING STUDY RESULTS.BASED ON DATA, JANSSEN PLANS TO DISCUSS POTENTIAL FOR A REGULATORY SUBMISSION WITH HEALTH AUTHORITIES.SECOND PART OF STUDY MET PRIMARY ENDPOINT.  Full Article

Janssen Receives Positive CHMP Opinion For Long-Acting Regimen For The Treatment Of Hiv
Friday, 16 Oct 2020 

Oct 16 (Reuters) - JANSSEN ::JANSSEN RECEIVES POSITIVE CHMP OPINION FOR LONG-ACTING REGIMEN FOR THE TREATMENT OF HIV.JANSSEN - CHMP OF EMA ISSUED A POSITIVE OPINION RECOMMENDING MARKETING AUTHORISATION FOR REKAMBYS IN COMBINATION WITH VIIV HEALTHCARE'S VOCABRIA.JANSSEN - LONG-ACTING, TWO-DRUG REGIMEN FOR HIV REDUCES TREATMENT INTAKE DAYS FROM 365 TO EITHER 12 OR SIX PER YEAR.  Full Article

NIH Launches Phase 3 Safety, Efficacy Trial Of 3 Immune Modulator Drugs In Hospitalized Adults With COVID-19
Friday, 16 Oct 2020 

Oct 16 (Reuters) - :NIH - ACTIV-1 IMMUNE MODULATORS TRIAL EXPECTS TO ENROLL ABOUT 2,100 HOSPITALIZED ADULTS WITH COVID-19 IN U.S. AND LATIN AMERICA.NIH - ACTIV-1 IM TRIAL AIMS TO DETERMINE IF MODULATING CERTAIN IMMUNE RESPONSE CAN REDUCE NEED FOR VENTILATORS & SHORTEN HOSPITAL STAYS.NIH - LAUNCHED PHASE 3 TRIAL TO EVALUATE SAFETY & EFFICACY OF 3 IMMUNE MODULATOR DRUGS IN HOSPITALIZED ADULTS WITH COVID-19.NIH - INITIAL AGENTS IN ACTIV-1 IM TRIAL ARE INFLIXIMAB DEVELOPED BY JANSSEN, ABATACEPT BY BRISTOL MYERS SQUIBB & CENICRIVIROC BY ABBVIE.  Full Article

J&J Reports Q3 EPS of $1.33
Tuesday, 13 Oct 2020 

Oct 13 (Reuters) - Johnson & Johnson ::QTRLY WORLDWIDE DARZALEX SALES ABOUT $1.10 BILLION VERSUS $765 MILLION.JOHNSON & JOHNSON REPORTS 2020 THIRD-QUARTER RESULTS.Q3 ADJUSTED EARNINGS PER SHARE $2.20.Q3 EARNINGS PER SHARE $1.33.Q3 EARNINGS PER SHARE ESTIMATE $1.98 -- REFINITIV IBES DATA.Q3 REVENUE $21.1 BILLION VERSUS REFINITIV IBES ESTIMATE OF $20.2 BILLION.COMPANY INCREASING GUIDANCE FOR FULL YEAR REPORTED SALES BY $1.0 BILLION AND ADJUSTED EPS BY $0.15.SEES FY ADJUSTED EPS $7.95 TO $8.05.SEES FY ADJUSTED OPERATIONAL SALES UP 0.5% TO 1.5%.SEES FY OPERATIONAL SALES $82.0 BILLION TO $82.8 BILLION.QTRLY WORLDWIDE IMBRUVICA SALES $1.03 BILLION VERSUS $921 MILLION.QTRLY SALES RISE DESPITE ESTIMATED NEGATIVE IMPACT OF COVID-19 PANDEMIC.QTRLY NON-GAAP MEDICAL DEVICES SALES $6.15 BILLION VERSUS $6.38 BILLION REPORTED LAST YEAR.QTRLY LITIGATION EXPENSE $1.48 BILLION VERSUS $4 BILLION REPORTED LAST YEAR.QTRLY WORLDWIDE REMICADE SALES $921 MILLION VERSUS $1.14 BILLION REPORTED LAST YEAR.CONSUMER HEALTH QTRLY SALES GROWTH DRIVEN BY U.S. GROWTH IN OVER-THE-COUNTER PRODUCTS INCL. TYLENOL ANALGESICS, DIGESTIVE HEALTH PRODUCTS, AMONG OTHERS.QTRLY NET OTHER EXPENSE $1.2 BILLION VERSUS $4.21 BILLION.  Full Article

J&J Reports Q3 Adjusted Earnings Per Share Of $2.20
Tuesday, 13 Oct 2020 

Oct 13 (Reuters) - Johnson & Johnson ::JOHNSON & JOHNSON REPORTS 2020 THIRD-QUARTER RESULTS.Q3 ADJUSTED EARNINGS PER SHARE $2.20.Q3 EARNINGS PER SHARE $1.33.Q3 EARNINGS PER SHARE ESTIMATE $1.98 -- REFINITIV IBES DATA.Q3 REVENUE $21.1 BILLION VERSUS REFINITIV IBES ESTIMATE OF $20.2 BILLION.COMPANY INCREASING GUIDANCE FOR FULL YEAR REPORTED SALES BY $1.0 BILLION AND ADJUSTED EPS BY $0.15.SEES FY ADJUSTED EPS $7.95 TO $8.05.SEES FY ADJUSTED OPERATIONAL SALES UP 0.5% TO 1.5%.SEES FY OPERATIONAL SALES $82.0 BILLION TO $82.8 BILLION.QTRLY WORLDWIDE IMBRUVICA SALES $1.03 BILLION VERSUS $921 MILLION.QTRLY SALES RISE DESPITE ESTIMATED NEGATIVE IMPACT OF COVID-19 PANDEMIC.QTRLY NON-GAAP MEDICAL DEVICES SALES $6.15 BILLION VERSUS $6.38 BILLION REPORTED LAST YEAR.QTRLY WORLDWIDE DARZALEX SALES $1.01 BILLION VERSUS $765 MILLION.QTRLY LITIGATION EXPENSE $1.48 BILLION VERSUS $4 BILLION REPORTED LAST YEAR.QTRLY WORLDWIDE REMICADE SALES $921 MILLION VERSUS $1.14 BILLION REPORTED LAST YEAR.CONSUMER HEALTH QTRLY SALES GROWTH DRIVEN BY U.S. GROWTH IN OVER-THE-COUNTER PRODUCTS INCL. TYLENOL ANALGESICS, DIGESTIVE HEALTH PRODUCTS, AMONG OTHERS.QTRLY NET OTHER EXPENSE $1.2 BILLION VERSUS $4.21 BILLION.  Full Article

Johnson & Johnson Temporarily Pauses All Dosing In Our Janssen Covid-19 Vaccine Candidate Clinical Trials
Tuesday, 13 Oct 2020 

Oct 12 (Reuters) - Johnson & Johnson ::JOHNSON & JOHNSON TEMPORARILY PAUSES ALL DOSING IN OUR JANSSEN COVID-19 VACCINE CANDIDATE CLINICAL TRIALS.J&J - TEMPORARILY PAUSED FURTHER DOSING IN ALL OUR COVID-19 VACCINE CANDIDATE CLINICAL TRIALS DUE TO UNEXPLAINED ILLNESS IN STUDY PARTICIPANT.J&J - PARTICIPANT’S ILLNESS BEING REVIEWED, EVALUATED BY ENSEMBLE INDEPENDENT DATA SAFETY MONITORING BOARD,INTERNAL CLINICAL AND SAFETY PHYSICIANS.J&J- ADVERSE EVENTS – ILLNESSES, ACCIDENTS, ETC. - EVEN THOSE THAT ARE SERIOUS, ARE AN EXPECTED PART OF ANY CLINICAL STUDY, ESPECIALLY LARGE STUDIES.  Full Article

Johnson And Johnson Announces European Commission Approval Of Agreement To Supply 200 Million Doses Of Janssens Covid-19 Vaccine Candidate
Thursday, 8 Oct 2020 

Oct 8 (Reuters) - Johnson & Johnson ::JOHNSON & JOHNSON ANNOUNCES EUROPEAN COMMISSION APPROVAL OF AGREEMENT TO SUPPLY 200 MILLION DOSES OF JANSSEN'S COVID-19 VACCINE CANDIDATE.J&J - AGREEMENT PROVIDES OPTION FOR EUROPEAN UNION MEMBER STATES TO SECURE UP TO 200 MILLION ADDITIONAL DOSES FOR A TOTAL OF UP TO 400 MILLION DOSES.J&J - PLANS TO ALLOCATE UP TO 500 MILLION VACCINE DOSES TOWARD INTERNATIONAL EFFORTS TO ENSURE ACCESS FOR LOWER INCOME COUNTRIES.J&J - ONGOING DISCUSSIONS WITH OTHER STAKEHOLDERS AS PART OF ITS EFFORTS TO MEET ITS COMMITMENT TO MAKE ITS COVID VACCINE CANDIDATE ACCESSIBLE GLOBALLY.J&J - WORKING TO FURTHER EXPAND NUMBER OF AVAILABLE DOSES OF JANSSEN'S COVID-19 VACCINE CANDIDATE.J&J - SECOND PHASE 3 STUDY WITH A TWO-DOSE REGIMEN IS PLANNED TO START LATER THIS YEAR.J&J - TO DATE, MORE THAN 100,000 INDIVIDUALS HAVE BEEN VACCINATED WITH A JANSSEN ADVAC-BASED VACCINE..J&J - ANTICIPATE COVID-19 VACCINE CANDIDATE TO BE COMPATIBLE WITH STANDARD DISTRIBUTION CHANNELS WITHOUT NEED FOR NEW DISTRIBUTION INFRASTRUCTURE.  Full Article

Johnson & Johnson Enters Agreement With GRAM To Manufacture SARS-CoV-2 Vaccine Candidate
Friday, 25 Sep 2020 

Sept 25 (Reuters) - Johnson & Johnson ::GRAND RIVER ASEPTIC MANUFACTURING - ENTERED AGREEMENT WITH JANSSEN PHARMACEUTICALS TO SUPPORT MANUFACTURE OF ITS SARS-COV-2 VACCINE CANDIDATE.GRAND RIVER ASEPTIC MANUFACTURING - AGREEMENT INCLUDES TECHNICAL TRANSFER & FILL AND FINISH MANUFACTURE OF J&J'S SARS-COV-2 VACCINE CANDIDATE.  Full Article

Janssen To Discontinue Pimodivir Influenza Development Program
Wednesday, 2 Sep 2020 

Sept 2 (Reuters) - Johnson & Johnson ::JANSSEN TO DISCONTINUE PIMODIVIR INFLUENZA DEVELOPMENT PROGRAM.JANSSEN PHARMACEUTICAL -DECISION BASED ON RECENT RESULTS FROM PRE-PLANNED INTERIM ANALYSES OF PIMODIVIR PHASE 3 TRIAL IN HOSPITALIZED PATIENTS WITH INFLUENZA A.JANSSEN - DATA SHOW THAT PIMODIVIR DOES NOT OFFER A BENEFIT ABOVE EXISTING STANDARD OF CARE.JANSSEN - PIMODIVIR PHASE 3 TRIAL IN INFLUENZA A FOUND PIMODIVIR IN COMBINATION WITH SOC WAS VERY UNLIKELY TO DEMONSTRATE ADDED BENEFIT.JANSSEN - STUDY IN HOSPITALIZED PATIENTS WITH INFLUENZA A AND PARALLEL PHASE 3 STUDY OF PIMODIVIR IN OUTPATIENTS WITH INFLUENZA A WILL BE HALTED.  Full Article

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AstraZeneca resumes U.S. COVID-19 vaccine trial and next week J&J prepares to do same

AstraZeneca Plc has resumed the U.S. trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial on Monday or Tuesday, the companies said on Friday.