Apellis Pharmaceuticals (APLS) Is Up 8.9% After FDA Approves EMPAVELI for Rare Kidney Diseases - Has The Bull Case Changed?

• Apellis Pharmaceuticals recently announced that the U.S. FDA approved EMPAVELI (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 and older to reduce proteinuria, based on positive six-month results from the VALIANT study.
• This regulatory milestone opens access to new markets for Apellis, addressing the needs of approximately 5,000 people affected by these rare kidney diseases in the United States.
• We’ll examine how EMPAVELI’s FDA approval for rare kidney diseases could influence Apellis Pharmaceuticals’ market reach and future earnings outlook.

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Apellis Pharmaceuticals Investment Narrative Recap

To be a shareholder in Apellis Pharmaceuticals, you need to believe in the potential for new drug launches and label expansions, like the FDA approval for EMPAVELI in rare kidney diseases, to drive long-term revenue growth and diversify risk beyond existing products. While this approval highlights progress in pipeline development and market reach, it does not immediately resolve current concerns about soft near-term revenue growth and ongoing margin pressures from high R&D spend, these remain the biggest catalysts and risks for the business in the short term.

The Q2 2025 earnings announcement is particularly relevant, as it revealed another period of declining revenue (US$178.49 million, down from US$199.69 million) and a widening net loss. This, alongside the new EMPAVELI approval, puts more emphasis on whether near-term commercial execution can offset increased investment and competitive headwinds as the rare disease franchise expands.

However, investors should be aware that if ongoing patient access and funding challenges are not meaningfully addressed, ...

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

Apellis Pharmaceuticals is projected to achieve $1.2 billion in revenue and $165.1 million in earnings by 2028. This scenario is based on an 18.0% annual revenue growth rate and an earnings increase of $393.3 million from current earnings of -$228.2 million.

Uncover how Apellis Pharmaceuticals' forecasts yield a $36.95 fair value, a 52% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members set fair values for Apellis between US$36.95 and US$98.78, with three distinct perspectives. While recent FDA approval offers new potential, ongoing revenue pressures could challenge future earnings momentum and impact these valuations.

Explore 3 other fair value estimates on Apellis Pharmaceuticals - why the stock might be worth over 4x more than the current price!

Build Your Own Apellis Pharmaceuticals Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Apellis Pharmaceuticals research is our analysis highlighting 3 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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