Moderna and Merck have announced positive results from the Phase 2b trial evaluating Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda in patients with high-risk melanoma. The study demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 44% compared with Keytruda alone. mRNA-4157 (V940) […]

Takeda has announced positive results from a Phase 2b clinical trial of a tyrosine kinase 2 (TYK2) inhibitor in patients with moderate-to-severe plaque psoriasis, meeting its primary and secondary endpoints compared to placebo. “We are confident that we can execute a comprehensive development program and deliver a potential best-in-class therapy for patients, given Takeda’s strong background […]

Novartis has announced positive topline results from an interim analysis of a Phase 3 trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in patients with a form of early breast cancer (EBC) at risk of recurrence. Kisqali has already been approved in 99 countries worldwide, including by the FDA and the European Commission, for treatment. of […]

Boston-based Karuna Therapeutics, a clinical-stage biopharma with a focus on psychiatric and neurological conditions, has announced positive topline results from its Phase 3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically […]

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling Biologics License Applications (BLAs) to the FDA for the investigational treatment exagamglogene autotemcel (exa-cel) for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The BLAs include requests for Priority Review, which, if granted, would shorten the FDA’s review of the application to eight months from the time of […]