uniQure BV (QURE) PT Lowered at RBC Capital After a 'Disappointing Regulatory Update'

RBC Capital analyst Luca Issi lowered the price target on uniQure BV (NASDAQ: QURE) to $45.00 (from $65.00) while maintaining an Outperform rating.

The analyst commented: "Disappointing Regulatory Update, but We Think Final Chapter Has Yet to Be Written; QURE announced today that the FDA has essentially changed their mind for Huntington's. Recall, 3-year data was presented a few weeks ago and efficacy hit the stats in a pre-specified analysis compared to external controls (p=0.003). However, we just caught up with the team, and QURE believes that the FDA no longer agrees that such data may be adequate for approval. This is because the FDA is arguing that the trial was hypothesis generating, the analysis was not pre-specified since day zero and there were other limitations including no clear dose response. We also believe that recent FDA leadership changes did contribute as Nicole Verdun (we think a supporter of accelerated approval) was escorted out of the building soon after the type B meeting where the SAP was discussed/ agreed on. The news is clearly disappointing, but we also note: 1) final minutes have yet to be received; 2) decision seems to contradict recent administration commentary around regulatory flexibility/right to try; and 3) we do expect patient advocacy groups and the scientific community to respond to the news. On #3, we do note that there are no disease modifying therapies for HD, the disease runs in families (asymptomatic patients often know what's coming given they have seen their family members slowly deteriorate and ultimately die) and the diagnosis does come with 12x higher risk of committing suicide. We are lowering our PoS from 75% to 50% but remain Outperform, Spec Risk as we believe the final chapter has yet to be written (clearly different circumstances, but we do think REPL reads favorably)."

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