Phase III
To expand the population for the anti-amyloid Alzheimer’s drugs, Lilly and Biogen are testing presymptomatic patients. Will doctors be open to this paradigm-shifting change?
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
Already sky high after the success of its limb-girdle muscular dystrophy therapy, reported on Monday, BridgeBio’s shares rose nearly 8% more as encaleret balanced calcium levels in patients with a genetic thyroid disorder.
Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space.
A key question for investors going forward will be whether Moderna’s other latent virus vaccines for Epstein-Barr and shingles can succeed after the failure of the CMV program.
The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.
With data from the Phase III STELLAR-303 study in the books, Exelixis is plotting a 2025 regulatory application for zanzalintinib.
In this episode presented by PII, BioSpace’s head of insights discusses decentralized clinical studies and how connected technology can improve patient compliance with guests Oliver Eden and Travis Webb.
After beating Novo Nordisk’s semaglutide last month, Lilly’s much anticipated oral candidate orforglipron has taken down AstraZeneca’s Farxiga in a head-to-head trial.
Findings from the Phase III VESALIUS-CV study reinforce the cholesterol-lowering benefit of Repatha in high-risk patients without prior cardiovascular disease, for which the drug was approved in August 2024.
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