Phase II
A thorough reassessment of the confounders between FibroGen’s trials is necessary to salvage the company’s Duchenne Muscular Dystrophy program and regain investor confidence.
The RNAi therapy, which the companies are co-developing and commercializing, reduced blood pressure in hypertensive patients with high cardiovascular risk by 15 mmHg over placebo.
Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases.
In a European Phase I/II clinical trial, the experimental drug for treating Crigler-Najjar syndrome reduced bilirubin below toxic threshold in the liver with a single intravenous injection.
The company is ending its investigational drug GB0139’s run in idiopathic pulmonary fibrosis after the small-molecule inhibitor failed to slow lung function decline in a Phase IIb study.
The clinical-stage company joins several others in the anti-CD47 space which have dropped studies amid poor results, including Gilead Sciences’ decision late last month to stop a Phase III trial.
Insilico’s AI platform has attracted interest from a growing number of biopharma companies. Meanwhile, several other firms highlight their own AI technologies.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.
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