Shares of Iveric Bio (ISEE) surged over 50% when Apellis Pharmaceuticals (APLS) announced mixed eye drug data. Despite the mixed showing, CEO Cedric Francois thinks the candidates’ performance was strong enough to warrant an FDA nod.
The company plans to file a marketing application to the FDA in 1H of FY22. In Oaks study, pegcetacoplan met its primary endpoint in both dosing groups, significantly reducing GA lesion growth by 22% in the monthly arm and 16% in the every-other-month group compared with sham injections after 12 months.
The drug failed to do the same in the Derby study, reducing lesions by 12% and 11%, respectively.
The drug didn’t produce any significant safety concerns in both trials, although its use was associated with slightly higher exudation rates or emitted fluid.
In a prespecified analysis of the combined trials, pegcetacoplan was more effective in patients with extrafoveal lesions, decreasing GA lesion growth in that group by 26% in the monthly arm and 23% in the every-other-month group.
ISEE attracts $22 price target
In addition to ISEE’s surge, a analyst at Annabel Samimy of Stifel attached a $22 price target and comments that, though the company is not a first mover in the still untapped Geographic Atrophy (GA) market, Iveric could very well be the leading treatment for this indication.
The company’s drug Zimura has demonstrated high statistical significance in the pivotal study and can potentially emerge as the only treatment that could prevent vision loss and function.
ISEE stock is up 62 at $14.12 during the mid-day session on Friday.
