On Wednesday, Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) announced data from a post hoc analysis of the GALE extension study following five years of continuous treatment with Syfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The results demonstrate that both every-other-month and monthly Syfovre delayed GA lesion growth by approximately 1.5 years in patients with nonsubfoveal GA when compared to sham/projected sham.
The analysis showed that monthly pegcetacoplan patients experienced a 31% reduction in lesion growth over 60 months compared to projected sham, while those receiving pegcetacoplan every other month experienced a 27% reduction compared to projected sham.
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William Blair said the results are consistent with the prior four-year analysis, which showed 32% and 27% reductions, respectively.
Over the five years, pegcetacoplan treatment effect translates to slowing lesion growth by roughly 16.5 months (PEOM) and 18.5 months (PM) compared to the projected sham. Analyst Lachlan Hanbury-Brown says the data reflect a meaningful slowing in disease progression and reinforce the durable efficacy of Syfovre.
Syfovre total injection demand grew 4% quarter-over-quarter in the third quarter, with U.S. net product revenue of $150.9 million.
Analyst Take
William Blair notes Apellis’ stock has been weak as the lack of copay assistance has curtailed Syfovre growth, despite a strong start to the Empaveli launch in C3G/IC-MPGN. The analyst views the weakness as a buying opportunity.
Analyst Hanbury-Brown says that Syfovre has blockbuster potential in GA over the long term, as its superior efficacy over competitor Astellas Pharma Inc.’s (OTC:ALPMF) (OTC:ALPMY) Izervay (avacincaptad pegol) should ultimately drive significant market share as physicians move beyond a focus on safety.
Syfovre’s resilience in new patient share over the past year shows that this process is already underway, William Blair wrote on Wednesday.
Apellis trades at an enterprise value of less than 3 times the 2025 revenue estimate, which reflects a value disconnect as investors’ focus on the near-term competitive pressure on Syfovre overlooks the long-term outlook. William Blair rates shares Outperform.
Price Action: APLS stock was trading higher by 2.52% to $20.01 at last check Wednesday.
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