uniQure price target lowered to $60 from $68 at Leerink

Leerink lowered the firm’s price target on uniQure (QURE) to $60 from $68 and keeps an Outperform rating on the shares following quarterly results and earnings call, which was “unsurprisingly” focused on the regulatory path for AMT-130 in Huntington’s disease. Leerink acknowledges the “surprise” last week when uniQure sounded the alarm and disclosed that the FDA no longer agreed that the data from the Phase 1/2 studies and prespecified analyses vs. an external control may be adequate to provide primary evidence in support of a BLA submission. On the call today, uniQure emphasized that this FDA reversal does not change their data for AMT-130 in HD that support real and serious disease modification. While this news has made timing of a BLA submission uncertain, the company plans to urgently engage with the FDA to discuss next steps, beginning with the formal meeting minutes.