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Category: Today’s Highlights

Reata Pharmaceuticals Submits MAA to the EMA for Chronic Kidney Disease Caused by Alport Syndrome

Reata Pharmaceuticals MAA Submission for Bardoxolone Methyl Reata Pharmaceuticals ( RETA ) announced the submission of a Marketing Authorization Application ( MAA ) for bardoxolone methyl to the European Medicines Agency ( EMA ) for chronic kidney disease ( CKD...

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October 29, 2021

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Important Steps Forward Taken by Vir Biotechnology and Separately by Compugen

Vir Biotechnology Vir Biotechnology ( VIR ) announced the dosing of the first patient in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial to evaluate VIR-2218 together with VIR-3434 for the treatment of patients with chronic...

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July 15, 2021

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Why Cytokinetics' Stock Price Soared in a Bad Market Day

Cytokinetics Positive Topline Results of CK-274 Cytokinetics ( CYTK ) announced positive topline results of Phase 2 clinical trial of CK-274 - an investigational cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy ( HCM ). The...

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July 19, 2021

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Reata Pharmaceuticals Third Quarter Financial Results and Other Company Updates

Reata Pharmaceuticals Business Operations and Clinical Development Updates Reata Pharmaceuticals ( RETA ) – a clinical-stage biopharmaceutical company announced financial results for the quarter ended September 30, 2021, and provided an update on the Company’s business operations and clinical development...

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November 8, 2021

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The FDA Approved Gilead Sciences CAR T Cell Product Tecartus for Adults with Relapsed or Refractory Mantle Cell Lymphoma

Gilead Sciences CAR T Cell Product Tecartus Gets FDA Approval The U.S. FDA approved Kite - Gilead Sciences ( GILD ) chimeric antigen receptor (CAR) T cell therapyTecartus™ (brexucabtagene autoleucel). Tecartus has become the first and the only approved CAR...

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July 27, 2020

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Merck and Ridgeback Biotherapeutics: U.S. Government to Purchase 1.4 M Additional Courses of Molnupiravir for COVID-19

U.S. Government to Purchase More of Merck and Ridgeback Biotherapeutics Molnupiravir for COVID-19 Merck ( MRK ) and Ridgeback Biotherapeutics announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional...

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November 9, 2021

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bluebird bio Receives Approval for its Gene Therapy SKYSONA™ for Young People with Early CALD Without a Matched Sibling Donor

bluebird bio   Receives EC Approval for  bluebird bio ( BLUE ) announced that the European Commission ( EC ) has granted marketing authorization of SKYSONA™ (elivaldogene autotemcel, Lenti-D™) one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy ( CALD ) in...

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July 22, 2021

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Crispr Therapeutics and ViaCyte Inc to Start Trial of First Gene-Edited Cell Replacement Therapy for Type 1Diabetes

Crispr Therapeutics and ViaCyte Inc to Start Trial of First Gene-Edited Cell Replacement Therapy CRISPR Therapeutics ( CRSP ) and ViaCyte, Inc. , announced that Health Canada approved their Clinical Trial Application ( CTA ) for the product VCTX210, an...

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November 16, 2021

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Regenxbio: Positive One-Year Data from the Firm's Gene Therapy RGX-314 for Wet AMD

Regenxbio Positive Data for RGX-314 Regenxbio ( RGNX ) reported positive one-year data from patients in Cohorts 4 and 5 from Phase I/IIa trial of RGX-314 for wet age-related macular degeneration ( wet AMD ). Regenxbio plans to initiate a...

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August 4, 2020

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GlaxoSmithKline and Vir Biotechnology Announced U.S. Gov't Contracts to Purchase $1B of Sotrovimab for COVID-19

GlaxoSmithKline and Vir Biotechnology Announces US Gov't Contracts to Purchase Sotrovimab for COVID-19 GlaxoSmithKline plc ( GSK ) and Vir Biotechnology ( VIR ) announced US government contracts totaling around $1 billion (USD) to purchase sotrovimab - an investigational monoclonal...

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November 17, 2021

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