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.
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