The U.S. Food and Drug Administration approved on Monday Apellis Pharmaceuticals, Inc.’s (NASDAQ:APLS) Empaveli (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria.
C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the U.S.
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The approval of Empaveli is based on six-month results from the VALIANT study, demonstrating benefits across all three key markers of disease:
The study met its primary endpoint, demonstrating a statistically significant 68% reduction in proteinuria in Empaveli-treated patients compared to placebo.
Empaveli-treated patients achieved stabilization of kidney function compared to placebo as measured by estimated glomerular filtration rate (eGFR).
A majority of Empaveli-treated patients achieved a reduction in C3 staining intensity compared to placebo.
Seventy-one percent of Empaveli-treated patients achieved zero C3 staining intensity, demonstrating complete clearance of C3 deposits.
The results were consistent across adolescent and adult patients with C3G and primary IC-MPGN, as well as in C3G patients with post-transplant disease recurrence.
William Blair writes, “Approval of Empaveli in C3G and IC-MPGN represents a major milestone for Apellis and opens up a significant commercial opportunity for the company with what we believe is a best-in-class profile for a market of roughly 5,000 patients in the U.S.”
Analyst Lachlan Hanbury-Brown also acknowledges that stock upside may be muted as questions linger about the trajectory of Syfovre.
Also Read: JP Morgan Cut Apellis’ Price Forecasts, Cites Longer Peak Sales Timing For Syfovre
“To that end, we continue to believe Syfovre has blockbuster potential in geographic atrophy over the long term, as its superior efficacy relative to competitor Izervay should ultimately drive significant market share as physicians move beyond a focus on safety, and we believe the increasing new patient share seen through April is indicative of this,” analyst Hanbury-Brown said in an investor note on Tuesday.
Apellis is trading at an enterprise value less than three times what William Blair expects the company to make in revenue in 2025. That’s lower than other mid-sized companies launching new products in big markets.
According to the analyst, this indicates a mismatch in how the company is valued, as investors appear to be overly focused on short-term competition for Syfovre and overlook the broader, long-term picture.
William Blair maintains an Outperform rating for Apellis Pharmaceuticals.
APLS Price Action: Apellis stock is up 0.88% at $ 18.92 at publication on Tuesday.
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