Roche to Move Quickly Toward Filing for Approval of New Autoimmune Drug

Dow Jones09-23

1418 GMT - Roche Holding is expected to move quickly to file for an accelerated approval for its sefaxersen drug candidate, a direct competitor to Novartis's Fabhalta, RBC Capital Markets analysts say. The Swiss drugmaker reported positive interim results for a late-stage study of sefaxersen in autoimmune disease IgA nephropathy and the company had previously said it hoped the data would lead to an accelerated approval, consistent with the Fabhalta precedent, RBC says. "We think the muted reaction in [Roche] shares downplays the impact of a positive early interim readout from this study in an indication where we model [1.5 billion Swiss francs] in 2034 sales," the analysts say in a research note. Nevertheless, the study results reduce the risk on that estimate and bode well for the Swiss drugmaker's pipeline, they add. Shares rise 0.8%.

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