Phase III
Cogent Biosciences expects to file a new drug application for bezuclastinib in gastrointestinal stromal tumors early next year after what Leerink said was “the first positive trial in this disease in over a decade.”
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
Multiple analyst firms were impressed by the Phase III data, which showed that Merck’s oral PCSK9 inhibitor can lower low-density lipoprotein cholesterol by more than 55% after 24 weeks.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
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.
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