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Roche Holding AG (RHHBY.PK)

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Latest Key Developments (Source: Significant Developments)

Roche Wins U.S. FDA Approval For Rozlytrek Cancer Treatment
Friday, 16 Aug 2019 

Aug 16 (Reuters) - Roche Holding AG ::FDA APPROVES ROCHE’S ROZLYTREKTM (ENTRECTINIB) FOR PEOPLE WITH ROS1-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER AND NTRK GENE FUSION-POSITIVE SOLID TUMOURS.FIRST FDA-APPROVED TREATMENT DESIGNED TO TARGET BOTH ROS1 AND NTRK THAT ALSO SHOWS RESPONSE IN CANCER THAT HAS SPREAD TO BRAIN.ROCHE'S FIRST FDA-APPROVED TUMOUR-AGNOSTIC MEDICINE.FDA HAS ALSO GRANTED ACCELERATED APPROVAL TO ROZLYTREK FOR TREATMENT OF ADULT AND PAEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMOURS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION.APPROVALS ARE BASED ON RESULTS FROM INTEGRATED ANALYSIS OF PIVOTAL PHASE II STARTRK-2, PHASE I STARTRK-1 AND PHASE I ALKA-372-001 TRIALS, AND DATA FROM PHASE I/II STARTRK-NG STUDY.  Full Article

Convelo Therapeutics To Acquire Genentech To Discover Novel Remyelinating Therapies
Tuesday, 16 Jul 2019 

July 16 (Reuters) - Roche Holding AG ::CONVELO THERAPEUTICS ENTERS INTO COLLABORATION AND OPTION TO ACQUIRE AGREEMENT WITH GENENTECH TO DISCOVER NOVEL REMYELINATING THERAPIES.CONVELO THERAPEUTICS - CONVELO WILL RECEIVE AN UNDISCLOSED UPFRONT PAYMENT AND RESEARCH SUPPORT FROM GENENTECH..CONVELO THERAPEUTICS - CONVELO AND GENENTECH WILL COLLABORATE TO DISCOVER NOVEL REMYELINATION THERAPIES FOR MS AND OTHER MYELIN DISORDERS.CONVELO - GENENTECH RETAINS EXCLUSIVE OPTION TO ACQUIRE OUTSTANDING STOCK OF CONVELO FOR ADDITIONAL UNDISCLOSED PAYMENT & DOWNSTREAM MILESTONES..  Full Article

Skyhawk Therapeutics Signs Agreement With Genentech To Develop Small Molecule RNA Splicing Modifiers For Oncology And Neurodegenerative Diseases
Tuesday, 16 Jul 2019 

July 16 (Reuters) - Roche Holding AG ::SKYHAWK THERAPEUTICS ANNOUNCES AGREEMENT WITH GENENTECH TO DISCOVER AND DEVELOP SMALL MOLECULE RNA SPLICING MODIFIERS FOR ONCOLOGY AND NEURODEGENERATIVE DISEASES.SKYHAWK THERAPEUTICS - SKYHAWK WILL RECEIVE AN UPFRONT PAYMENT AND MAY BE ELIGIBLE FOR MORE THAN $2 BILLION OVER TIME.SKYHAWK THERAPEUTICS - WILL USE SKYSTAR PLATFORM TO DEVELOP DRUG CANDIDATES DIRECTED TO MULTIPLE TARGETS FOR ONCOLOGY AND NEURODEGENERATIVE DISEASES.SKYHAWK THERAPEUTICS - AGREEMENT GRANTS GENENTECH AN EXCLUSIVE WORLDWIDE LICENSE TO DEVELOP AND COMMERCIALIZE POTENTIAL THERAPEUTICS.SKYHAWK THERAPEUTICS - GENENTECH WILL BE RESPONSIBLE FOR CLINICAL DEVELOPMENT AND COMMERCIALIZATION..SKYHAWK - DEAL ALSO INCLUDES ROYALTIES ON SALES OF COMMERCIALIZED MEDICINES.  Full Article

ImaginAb Inc Says It Entered Non-Exclusive License And Collaboration Agreement With Roche
Tuesday, 9 Jul 2019 

July 9 (Reuters) - :IMAGINAB INC SAYS IT ENTERED INTO NON-EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT WITH ROCH; FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED..IMAGINAB INC SAYS ROCHE WILL USE IMAGINAB'S NOVEL MINIBODY CD8 T CELL IMAGING AGENT IN IMMUNO-ONCOLOGY CLINICAL TRIALS FOR MULTIPLE TYPES OF CANCERS.  Full Article

Roche Presents Data For Hemlibra At ISTH 2019 Congress
Tuesday, 9 Jul 2019 

July 9 (Reuters) - Roche Holding AG ::NEW ANALYSES FROM PHASE III HAVEN STUDIES SUPPORT HEMLIBRA'S SUSTAINED EFFICACY, SAFETY AND QUALITY OF LIFE BENEFIT IN PEOPLE WITH HAEMOPHILIA A, WITH AND WITHOUT FACTOR VIII INHIBITORS.FIRST DATA OF PHASE IIIB STASEY STUDY REINFORCES SAFETY PROFILE OF HEMLIBRA SEEN IN PIVOTAL HAVEN 1 CLINICAL TRIAL.NEW ANALYSIS OF PIVOTAL DATA SUGGESTS ADDITIONAL FACTOR TREATMENT MAY NOT BE NEEDED FOR PEOPLE ON HEMLIBRA UNDERGOING CERTAIN MINOR SURGERY.  Full Article

Roche: Rituximab Phase III Study Met Primary Endpoint
Thursday, 13 Jun 2019 

June 13 (Reuters) - Roche Holding AG ::PHASE III PEMPHIX STUDY SHOWED THAT MABTHERA/RITUXAN (RITUXIMAB) IS SUPERIOR TO STANDARD OF CARE IN ACHIEVING SUSTAINED REMISSION IN PATIENTS WITH PEMPHIGUS VULGARIS.MABTHERA/RITUXAN MET THE PRIMARY AND SECONDARY ENDPOINTS IN THE PHASE III PEMPHIX STUDY.LATEST PHASE IIISTUDY MET THE PRIMARY ENDPOINT, AND DEMONSTRATED THAT MABTHERA IS SUPERIOR TO MMF IN ACHIEVING SUSTAINED COMPLETE REMISSION.  Full Article

FDA Grants Priority Review To Roche’S Rituximab In Children With Blood Vessel Disorders
Wednesday, 12 Jun 2019 

June 12 (Reuters) - Roche Holding AG ::FDA GRANTS PRIORITY REVIEW TO GENENTECH’S RITUXAN (RITUXIMAB) IN CHILDREN WITH TWO RARE BLOOD VESSEL DISORDERS.PEPRS STUDY IS FIRST GLOBAL TRIAL OF RITUXAN IN PEDIATRIC PATIENTS WITH GPA OR MPA.RITUXAN IN COMBINATION WITH GLUCOCORTICOIDS IS ONLY FDA-APPROVED THERAPY FOR ADULTS WITH THESE TWO RARE FORMS OF VASCULITIS.IF APPROVED, THIS WOULD BE FIRST PEDIATRIC INDICATION FOR RITUXAN.  Full Article

FDA Grants Genentech’s Polivy Accelerated Approval For People With Previously Treated Aggressive Lymphoma
Monday, 10 Jun 2019 

June 10 (Reuters) - Genentech::FDA GRANTS GENENTECH’S POLIVY ACCELERATED APPROVAL FOR PEOPLE WITH PREVIOUSLY TREATED AGGRESSIVE LYMPHOMA.GENENTECH - ACCELERATED APPROVAL OF POLIVY WAS BASED ON RESULTS FROM PHASE IB/II GO29365 STUDY.  Full Article

FDA Approves First Chemoimmunotherapy Regimen For Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma
Monday, 10 Jun 2019 

June 10 (Reuters) - FDA::FDA APPROVES FIRST CHEMOIMMUNOTHERAPY REGIMEN FOR PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA.FDA SAYS GRANTED APPROVAL OF POLIVY TO GENENTECH.  Full Article

Roche And Spark Therapeutics Receive Information Request From Federal Trade Commission
Monday, 10 Jun 2019 

June 10 (Reuters) - ROCHE HOLDING AG ::ROCHE AND SPARK THERAPEUTICS, INC. RECEIVE REQUEST FOR ADDITIONAL INFORMATION FROM FTC UNDER HART-SCOTT-RODINO ACT AND ANNOUNCE EXTENSION OF TENDER OFFER FOR SHARES OF SPARK THERAPEUTICS, INC..EFFECT OF SECOND REQUEST IS TO EXTEND WAITING PERIOD UNTIL 10 DAYS AFTER ROCHE HAS SUBSTANTIALLY COMPLIED WITH SECOND REQUEST.PARTIES REMAIN COMMITTED TO TRANSACTION.ALL TERMS AND CONDITIONS OF OFFER SHALL REMAIN UNCHANGED DURING EXTENDED PERIOD.  Full Article

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Roche taps Lilly executive Garraway as chief medical officer

ZURICH Swiss drugmaker Roche Holding on Monday named Eli Lilly executive Levi Garraway to succeed Sandra Horning as chief medical officer and head of global product development.