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Roche Holdings AG said it will begin a late-stage trial to evaluate whether its experimental Alzheimer’s drug, trontinemab, can prevent cognitive symptoms in high-risk individuals.
The study is Roche’s third large trial for trontinemab, which uses a brain shuttle technology to cross the blood-brain barrier, Bloomberg reported.
The therapy is a newer version of gantenerumab, an earlier Roche candidate that failed to slow the decline in Alzheimer’s patients.
Like Eli Lilly’s Kisunla and Leqembi (co-developed by Eisai and Biogen), trontinemab is designed to clear amyloid protein buildup in the brain.
Roche is also developing a diagnostic blood test for preclinical Alzheimer’s, which a 2022 study in Alzheimer’s & Dementia estimated may affect up to 315 million people globally.
Roche’s Alzheimer’s trial announcement comes just as the company hit a roadblock in another major drug program. On Thursday, European regulators said they would not recommend approval of Elevidys, a gene therapy for Duchenne muscular dystrophy developed by Sarepta and licensed to Roche outside the U.S.
Roche said on Friday that it was disappointed by the decision and plans to continue working with the agency to determine a path forward.
"We are disappointed by the CHMP’s (Committee for Medicinal Products for Human Use) negative opinion, given the urgent need for disease-modifying therapies for children in the EU living with Duchenne," said Levi Garraway, Chief Medical Officer at Roche.
The company said it still believes the therapy’s benefits outweigh the risks for children who are still able to walk.
On Stocktwits, retail sentiment for Roche was ‘bullish’ amid ‘extremely high’ message volume.
Roche’s U.S. shares have risen 17.3% so far in 2025.
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