Topic: clinical trial data
A phase 3 trial of Myovant Sciences’ relugolix in prostate cancer has met its primary endpoint, teeing the company up to file for FDA approval.
The top-line readout appears to justify the risk the partners took when they advanced the drug despite missing the primary endpoint in phase 2.
Inclisiran achieved a placebo-adjusted drop in LDL cholesterol of 58%, although it failed to drive positive changes in cardiovascular outcomes.
Amgen has found no evidence that heart failure drug omecamtiv mecarbil hampers diastolic function in a post hoc analysis of phase 2 data.
VistaGen responded to the failure of the ketamine-line drug by vowing to review all the data before deciding on next steps.
AstraZeneca is confident data generated across development show the antibody works despite a pivotal study missing its primary endpoint.
Reata’s bardoxolone improved kidney function in a phase 3 trial of patients with a rare form of chronic kidney disease.
The results tee Roche up to file for approval to compete with Biogen and Novartis in the increasingly crowded spinal muscular atrophy market.
The phase 1/2 results show the efficacy seen at 12 months has persisted, providing early evidence of durable responses.
AnaptysBio's anti-IL-33 antibody did worse than placebo at easing eczema symptoms such as itch and skin inflammation after 16 weeks of treatment.