Apellis Pharmaceuticals (APLS) Is Up 22.4% After First FDA Approval for EMPAVELI in Rare Kidney Diseases

Simply Wall St.
Aug 05
  • In July 2025, Apellis Pharmaceuticals received U.S. FDA approval for EMPAVELI (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years and older, based on positive six-month results from the VALIANT study.
  • This regulatory milestone expands Apellis’s commercial presence into rare kidney diseases, an area with significant unmet need and few available therapies.
  • We’ll consider how this first-to-market approval for EMPAVELI in rare nephrology could reshape Apellis Pharmaceuticals’ investment narrative going forward.

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Apellis Pharmaceuticals Investment Narrative Recap

To be a confident shareholder in Apellis Pharmaceuticals today, you need to believe in the company’s ability to turn breakthrough approvals into robust, sustainable growth while managing its pronounced dependency on a narrow product lineup. The FDA approval of EMPAVELI for rare kidney diseases is an important catalyst, expanding Apellis’s addressable market in the near term, but does not fundamentally alter the ongoing revenue concentration risk that weighs most heavily on the business. If EMPAVELI and SYFOVRE face setbacks, the bottom line could be quickly impacted.

Among recent company actions, Apellis’s $300 million capped royalty purchase agreement with Sobi stands out as especially relevant. This arrangement provides immediate financial flexibility as the company moves to commercialize EMPAVELI in new indications, helping to offset current losses and fund ongoing development, which is important while Apellis builds toward broader portfolio diversification.

However, even with new approvals, there is still the risk that heavy reliance on just two commercial assets leaves the business exposed if competitive threats or reimbursement changes emerge, investors should be aware that ...

Read the full narrative on Apellis Pharmaceuticals (it's free!)

Apellis Pharmaceuticals' outlook anticipates $1.2 billion in revenue and $179.9 million in earnings by 2028. This scenario assumes a 17.1% annual revenue growth rate and a $403.6 million improvement in earnings from the current level of -$223.7 million.

Uncover how Apellis Pharmaceuticals' forecasts yield a $35.60 fair value, a 55% upside to its current price.

Exploring Other Perspectives

APLS Community Fair Values as at Aug 2025

Simply Wall St Community members have fair value estimates for Apellis Pharmaceuticals ranging from US$35.60 to US$110.99, based on three distinct analyses. While optimism around the addressable market grows after EMPAVELI’s approval, you should weigh how ongoing reliance on SYFOVRE and EMPAVELI shapes the company’s future resilience.

Explore 3 other fair value estimates on Apellis Pharmaceuticals - why the stock might be worth just $35.60!

Build Your Own Apellis Pharmaceuticals Narrative

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  • A great starting point for your Apellis Pharmaceuticals research is our analysis highlighting 4 key rewards that could impact your investment decision.
  • Our free Apellis Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Apellis Pharmaceuticals' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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