Roche Holding AG could be third to market in the autoimmune disease lupus nephritis after claiming a topline hit in the pivotal REGENCY trial. More people responded to the anti-CD20 antibody in the Phase III study than responded to placebo, and Roche intends to get the drug on the market in this new use “as soon as possible”.
REGENCY Dandy for Roche In Lupus Nephritis
Gazyva could add the autoimmune condition to its label following a Phase III hit, but it might struggle to differentiate itself from Benlysta and Lupkynis.
More from Clinical Trials
• By
RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
• By
The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.
• By
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
• By
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.
More from R&D
• By
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares
• By
The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.
• By
A decision from the FDA is due by 28 September.