Roche Puts Alzheimer's Candidate, Gantenerumab In Spotlight; In Dialogue with FDA: Reuters

• Roche Holding AG (OTC: RHHBY) is reportedly talking to the FDA about its Alzheimer’s disease drug candidate, gantenerumab.

• CEO Severin Schwan declined to speculate on the outcome of the talks, Reuters reported.

• The accelerated approval of Biogen’s Aduhelm has opened the door to the approval of Alzheimer’s drug candidates on the strength of surrogate endpoints.

• Roche dismissed the analyst report, stating it is focused on its phase 3 and engaging in discussions with the FDA “when appropriate.” Schwan has told reporters from publications, including Reuters, that Roche is talking to the FDA.

• Roche will complete a Phase-3 trial of the medicine in 2H of 2022.

• “There is a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be,” he said. “Our trial is a well-designed, very comprehensive trial, so, whatever the outcome of this trial will be, we will have a definitive answer of what we can do for patients with this terrible disease, so let’s keep fingers crossed.”

• Earlier today, Roche announced half-yearly sales increased by 8% Y/Y to CHF 30.7 billion as demand for COVID-19 tests recovered.

• Price Action: RHHBY shares are down 3.2% at $46.55 during the market session on the last check Thursday.

• Related content: Benzinga's Full FDA Calendar.

See more from Benzinga

• Click here for options trades from Benzinga

• Rebound In COVID-19 Tests Lift Roche's Half-Year Sales, Oncology Still Hit By Biosimilars, Pandemic

• Spark Therapeutics' Hemophilia Gene Therapy Achieve Stable, Durable FVIII Expression

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.