Roche's Alzheimer's Candidate Secures FDA Breakthrough Designation

by Vandana Singh, Benzinga Editor

October 8, 2021 3:37 PM | 1 min read |

Roche Holdings AG's RHHBY gantenerumab antibody received breakthrough therapy designation from the FDA for Alzheimer's disease.
Gantenerumab is designed to neutralize beta-amyloid plaques seen as a driver behind brain cell death.
The Company said that the U.S. breakthrough designation was based on data showing that gantenerumab had significantly reduced brain amyloid plaque in ongoing trials.
Related: Roche's Alzheimer's Antibody Reduces Associated Biomarkers In Subset Of AD Patients, Study Shows.
The pivotal trials are evaluating gantenerumab in over 2,000 participants for more than two years and are expected to be completed in 2H of 2022.
Related content: Benzinga's Full FDA Calendar.
Price Action: RHHBY shares are up 3.31% at $49.64 during the market session on the last check Friday.