Roche's Alzheimer's Candidate Secures FDA Breakthrough Designation
- Roche Holdings AG's (OTC: 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.
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