Apellis delay raises eyebrows, but Iveric cannot celebrate yet
There was always a chance that Apellis’s shot at FDA approval for intravitreal pegcetacoplan would miss the goal, and the group’s sudden decision to submit longer-term data to the regulator confirms those fears. Only one of two phase 3 geographic atrophy studies met their primary endpoint, a hiccup that lies behind Apellis’s move. The company couched it as strengthening “the product profile at launch” but investors were not convinced. The stock slumped 16% this morning, wiping $1bn from a company whose valuation assumes an FDA green light. The situation is of course more complicated than one positive and one negative trial. Patients’ visual acuity deteriorated – the primary endpoint was an anatomical measure of GA lesion growth – and with nothing on the market for the eye disease, the FDA was always going to dig deep. This also means a three month Pdufa date delay, to February next year, which matters because GA is being hotly contested. Iveric chose yesterday to remind the market that it is snapping at Apellis’s heels, announcing the first submission for its rival project, Zimura. Iveric also opened down 11% today, however. Perhaps investors reckon the path forward for all these contenders just got rockier.