Apellis Pharma Phase 3 VALIANT Study Of Pegcetacoplan Meets Primary Goal; Stock Up In Pre-market

(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) and Sobi (SOBI) Thursday said Phase 3 VALIANT study of pegcetacoplan met its primary goal. The shares were up more than 10 percent in pre-market to $37.03.

The study evaluated pegcetacoplan in patients with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases with no approved treatments.

Results from the study showed a statistically significant and clinically meaningful 68 percent proteinuria reduction in C3G and IC-MPGN patients treated with pegcetacoplan compared to placebo. Results were consistent across all subgroups including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys.

In the VALIANT study, pegcetacoplan showed favourable safety and tolerability, consistent with its established profile.

Sobi plans to submit a marketing application with the European Medicines Agency (EMA) in 2025. Apellis also plans to submit a supplemental new drug application to the U.S. Food and Drug Administration (FDA) in early 2025.

Apellis stock had closed at $33.59, down 4.33 percent on Wednesday. It has traded in the range of $23.86 - $73.80 in the last 1 year.