Phase I
Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.
The company has dropped its gene therapy candidate TSHA-120 for giant axonal neuropathy after the FDA reiterated the need for a randomized, double-blind, placebo-controlled trial.
Bristol Myers Squibb’s pipeline cuts, announced Thursday during its R&D Day, include a mid-stage drug candidate for nonalcoholic steatohepatitis and an anti-TIGIT solid tumor program.
During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.
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.
Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.
Data suggests divarasib could be more potent than already approved KRAS inhibitors from Amgen and Mirati, but the study’s authors caution against cross-trial comparisons.
The companies will evaluate Moderna’s investigational Claudin18.2 mRNA cancer vaccine in combination with CARsgen’s Claudin18.2 CAR T cell candidate.
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’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
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