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Fri. 8 Oct 2021, 3:37pm ETBenzinga
In: Biotech, News, Health Care, FDA, Movers, Trading Ideas, General
  • 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.