Phase III
The company is continuing its renal cell carcinoma push for its oral HIF-2α inhibitor Welireg with promising Phase III data showing significant progression-free survival improvements in patients.
The German company on Thursday said it is launching three late-stage studies of its obesity drug candidate after the injectable showed up to 19% weight loss after 46 weeks in a mid-stage trial.
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
Ahead of an FDA decision in the third quarter, Regeneron is touting promising durability data from the Phase III PULSAR trial for higher-dose Eylea in patients with wet age-related macular degeneration.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
With a potential $509 billion up for grabs by 2028, companies including Biogen, Sage, Karuna Therapeutics and Cerevel Therapeutics are vying to bring their drugs across the regulatory finish line.
Late-stage data from two studies showed Novartis’ BTK inhibitor remibrutinib improves symptoms of chronic spontaneous urticaria. The company will file for regulatory approval in 2024.
Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.
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