Gilead weekly oral hold should not affect lenacapavir PDUFA, says RBC Capital

RBC Capital notes that Gilead (GILD) shared a statement that its weekly oral HIV treatment program 1720/4182 combo has been placed on a clinical hold following decreases in CD4 and lymphocyte counts observed in subset of patients. The firm’s view had been that ‘1720 had not been tested widely enough to de-risk on safety based on some lab findings in its earlier clinical studies and that there would be a high hurdle for market conversion once Biktarvy goes generic anyway even if this weekly oral regimen ultimately became available, the analyst tells investors. However, the clinical hold is “not insurmountable” and the firm does not believe this is likely to derail lenacapavir’s upcoming approval for PrEP despite ‘4182 being a lena prodrug, the analyst tells investors. Still, the firm acknowledges the timing just ahead of the lena PDUFA date is “not great, if FDA were trying to find some excuse to delay its approval.” RBC remains neutral on Gilead shares with a Sector Perform rating.