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Category: Today’s Highlights

Vir Biotechnology: Promising Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 for Chronic HBV Infection  

Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology ( VIR ) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with...

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June 25, 2021

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BrainStorm Cell Therapeutics: Another Clinical-Stage Small Firm's Product for the Devastating Disease ALS

BrainStorm Cell Therapeutics Inc BrainStorm Cell Therapeutics Inc ( BCLI ) develops innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous...

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March 27, 2023

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The U.S. FDA Accepted Checkpoint Therapeutics Biotech BLA for Cosibelimab

Checkpoint Therapeutics Checkpoint Therapeutics ( CKPT ) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab,...

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March 31, 2023

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Orchard Therapeutics: FDA Acceptance of BLA Application for Product OTL-200 for the Treatment of Metachromatic Leukodystrophy

Orchard Therapeutics in the NEWS Today, September 18, 2023, Orchard Therapeutics ( ORTX ) - a global gene therapy firm, announced that the U.S. FDA has accepted the filing of its Biologics License Application ( BLA ) for OTL-200 in...

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September 18, 2023

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The EU CHMP Agency Recommended Approval of TG Therapeutics Firm's BRIUMVI™ for Relapsing Forms of MS in Adults

TG Therapeutics TG Therapeutics, Inc. ( TGTX ) announced today that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion recommending the approval of BRIUMVITM...

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March 31, 2023

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Reata Stock Holders Approved the Firm's Merger with Biogen

Reat Pharmaceuticals Merger with Biogen Reata Pharmaceuticals announced that at a special meeting held today, preliminary results indicate that the stockholders of the firm have voted to approve the Company’s previously announced acquisition (the “Merger”) by Biogen ( BIIB )...

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September 21, 2023

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IVERIC bio Receives FDA Agreement Under an SPA for GATHER2 Phase 3 Clinical Trial of Zimura®

IVERIC bio GATHER2 Trial of Zimura® for Geographic Atrophy  IVERIC Bio ( ISEE ) announced that it received written agreement from the U.S. FDA under a Special Protocol Assessment ( SPA ) for the overall design of GATHER2, the pivotal...

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July 6, 2021

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Vertex and CRISPR Complete Submission of BLAs to the US FDA for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Vertex Pharmaceuticals and CRISPR Therapeutics Completion of BLAs Vertex Pharmaceuticals ( VRTX ) and CRISPR Therapeutics ( CRSP ) announced the completion of the rolling Biologics License Applications ( BLAs ) to the FDA for the investigational treatment exagamglogene autotemcel...

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April 3, 2023

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Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data from Phase 2a INTEGRIS-PSC Clinical Trial of Bexotegrast

Pliant Therapeutics in the NEWS Treating Primary Sclerosing Cholangitis  Pliant Therapeutics ( PLRX ) today announced positive data from a Phase 2a INTEGRIS-PSC clinical trial of the firm’s product bexotegrast in patients with primary sclerosing cholangitis ( PSC ) and...

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September 26, 2023

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Regenxbio Receives FDA Fast Track Designation for RGX-202 for the Treatment of Duchenne Muscular Dystrophy  

Regenxbio in the NEWS Today, the U.S. FDA granted Fast Track designation for Regenxbio ( RGNX ) Gene therapy RGX-202 a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). Therapies granted Fast Track designation are given the...

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April 11, 2023

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