Apellis Receives FDA Approval for EMPAVELI to Treat C3G with 68% Proteinuria Reduction
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 03 2025
0mins
Should l Buy APLS?
Source: Newsfilter
- Clinical Trial Success: The VALIANT study demonstrated that EMPAVELI significantly benefits C3G and IC-MPGN patients, achieving a 68% reduction in proteinuria, marking a major breakthrough that could transform patient quality of life.
- Kidney Function Stabilization: EMPAVELI stabilized kidney function with a +6.3 mL/min/1.73 m² increase in eGFR, indicating its potential to delay kidney failure and reduce the need for dialysis or transplantation among patients.
- Good Safety Profile: The VALIANT study confirmed EMPAVELI's safety profile consistent with previous data, with no reported cases of meningococcal infections, enhancing physician confidence in its clinical application.
- Broad Market Potential: As the first FDA-approved treatment for C3G and IC-MPGN, EMPAVELI is expected to attract a significant patient population, addressing the urgent market demand for new therapies and driving long-term growth for Apellis.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy APLS?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on APLS
Wall Street analysts forecast APLS stock price to rise
14 Analyst Rating
9 Buy
5 Hold
0 Sell
Moderate Buy
Current: 22.050
Low
22.00
Averages
43.25
High
117.80
Current: 22.050
Low
22.00
Averages
43.25
High
117.80
About APLS
Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of novel therapeutic compounds to treat diseases with high unmet needs through the inhibition of the complement system. SYFOVRE (pegcetacoplan injection) is the Company’s approved treatment for geographic atrophy secondary to age-related macular degeneration (GA). Its EMPAVELI (pegcetacoplan) is for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Its Aspaveli (pegcetacoplan) for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months. Systemic pegcetacoplan has also been approved for the treatment of PNH in Japan, Saudi Arabia, Australia, the United Kingdom and other jurisdictions. Systemic pegcetacoplan is marketed under the trade name EMPAVELI in the United States, Saudi Arabia and Australia and Aspaveli in the European Union, Japan and the United Kingdom.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several stocks, including upgrades, downgrades, and initiations, reflecting varying market perspectives on these companies.
- Market Dynamics Observation: While specific stock names are not mentioned, changes in analyst ratings typically influence investor decisions, potentially leading to price volatility in the affected stocks.
- Investor Attention: Investors considering buying OKLO stock should pay attention to analysts' opinions to make more informed investment decisions, especially amid increasing market uncertainty.
- Impact of Rating Changes: Analyst rating adjustments not only affect short-term market sentiment but may also have profound implications for the long-term stock performance of the companies involved, necessitating close monitoring of subsequent developments.
See More
Apellis Pharmaceuticals' Empaveli Approved, Projected $508 Million Sales by 2033
- Market Potential Unveiled: Apellis Pharmaceuticals' Empaveli received FDA approval in 2025 as the first treatment for C3 glomerulopathy, which is expected to significantly enhance the company's revenue outlook over the coming years.
- Early Commercial Performance: In Q3, Empaveli generated $27 million in U.S. net product revenue, with 267 new patient start forms recorded since its late July approval, indicating a 5% market penetration and strong acceptance.
- Competitive Advantage: The broader label of Empaveli is driving early uptake, with management asserting its efficacy surpasses Novartis' Fabhalta, projecting peak U.S. sales of $508 million by 2033, which could further elevate the company's valuation.
- Future Catalysts: Analysts noted that the anticipated filing for Syfovre's prefilled syringe in the first half of 2026 could lead to market share expansion and overall market growth, with potential impacts expected in 2027.
See More
Bank of America Upgrades Apellis Pharmaceuticals to Buy, Highlights Strong Empaveli Launch
- Strong Market Performance: Since receiving FDA approval for Empaveli in July for C3 glomerulopathy, Apellis has recorded 267 new patient start forms, indicating robust market demand and product acceptance.
- Payer Progress: Management reports no full denials to date, suggesting that Empaveli's broader label and superior efficacy compared to Novartis' Fabhalta have facilitated rapid market penetration.
- EU Approval Boost: Apellis' partner Sobi recently received EU approval for the drug against C3G and IC-MPGN, further enhancing Empaveli's competitive position in international markets.
- Growth Potential: With the price target unchanged at $28 per share, analysts believe there is room for continued upside as momentum builds in the coming quarters.
See More
Sobi Secures EU Approval for Aspaveli in Rare Kidney Disorders
- Drug Approval: Swedish Orphan Biovitrum (Sobi) announced that its blood disorder therapy Aspaveli received approval from the European Commission, allowing it to treat patients aged 12-17 with C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis, estimated to affect up to 8,000 patients in Europe, significantly expanding its market share in the rare disease sector.
- Market Collaboration: Aspaveli is marketed in collaboration with Apellis Pharmaceuticals, whose Empaveli generated $67.3 million in net product revenue during the first nine months of 2025, indicating the market potential and commercial value of the drug in treating related conditions.
- Regulatory Consistency: The approval aligns with the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December, reflecting regulatory recognition of Aspaveli's efficacy and laying a foundation for Sobi's further development in the European market.
- Strategic Implications: By securing approval for Aspaveli, Sobi not only enhances its competitiveness in the rare kidney disease treatment space but also creates favorable opportunities for future market expansion and new product development, aligning with the company's long-term growth strategy.
See More
Wall Street Trades Cautiously as CPI Rises 2.7% Amid Weak Earnings Reports
- Stable Inflation Data: The Consumer Price Index (CPI) rose 2.7% year-over-year in December, matching both prior readings and economist expectations, indicating that inflationary pressures remain stable and potentially supporting future Federal Reserve rate cuts.
- Silver Price Surge: Supply concerns drove silver prices up 4.5% to $89 per ounce, marking a 22% increase since the start of the year, reflecting strong market demand and heightened risk aversion among investors.
- Major Indices Performance: By midday, the S&P 500 index remained flat at 6,970, close to the record high of 6,986 set the previous day, while the Dow Jones Industrial Average fell 0.5%, indicating cautious market sentiment.
- Stock Movements: Despite JPMorgan Chase (JPM) beating earnings estimates, its stock fell over 3%, reflecting investor concerns over weak investment banking fees, while Moderna (MRNA) surged 14% due to bullish growth forecasts in its vaccine business, highlighting a preference for biotech stocks in the current market environment.
See More
Telsey Raises Five Below Inc Price Target to $240
- Price Target Increase: Telsey Advisory Group raised the price target for Five Below Inc from $195 to $240, with analyst Joseph Feldman maintaining an Outperform rating, indicating strong confidence in the company's future growth prospects.
- Rating Maintained: Despite HC Wainwright & Co. cutting Lexeo Therapeutics Inc's price target from $13 to $10, analyst Mitchell S. Kapoor maintained a Buy rating, reflecting optimism about its long-term potential.
- Price Target Cut: Needham reduced the price target for Apellis Pharmaceuticals Inc from $29 to $28, yet analyst Joseph Stringer upheld a Buy rating, demonstrating ongoing confidence in the company's fundamentals.
- Rating Downgrade: Daiwa Capital lowered PayPal Holdings Inc's price target from $77 to $61 and downgraded the rating from Outperform to Neutral, indicating a cautious outlook on its future performance.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several stocks, including upgrades, downgrades, and initiations, reflecting varying market perspectives on these companies.
- Market Dynamics Observation: While specific stock names are not mentioned, changes in analyst ratings typically influence investor decisions, potentially leading to price volatility in the affected stocks.
- Investor Attention: Investors considering buying OKLO stock should pay attention to analysts' opinions to make more informed investment decisions, especially amid increasing market uncertainty.
- Impact of Rating Changes: Analyst rating adjustments not only affect short-term market sentiment but may also have profound implications for the long-term stock performance of the companies involved, necessitating close monitoring of subsequent developments.
See More
Apellis Pharmaceuticals' Empaveli Approved, Projected $508 Million Sales by 2033
- Market Potential Unveiled: Apellis Pharmaceuticals' Empaveli received FDA approval in 2025 as the first treatment for C3 glomerulopathy, which is expected to significantly enhance the company's revenue outlook over the coming years.
- Early Commercial Performance: In Q3, Empaveli generated $27 million in U.S. net product revenue, with 267 new patient start forms recorded since its late July approval, indicating a 5% market penetration and strong acceptance.
- Competitive Advantage: The broader label of Empaveli is driving early uptake, with management asserting its efficacy surpasses Novartis' Fabhalta, projecting peak U.S. sales of $508 million by 2033, which could further elevate the company's valuation.
- Future Catalysts: Analysts noted that the anticipated filing for Syfovre's prefilled syringe in the first half of 2026 could lead to market share expansion and overall market growth, with potential impacts expected in 2027.
See More
Bank of America Upgrades Apellis Pharmaceuticals to Buy, Highlights Strong Empaveli Launch
- Strong Market Performance: Since receiving FDA approval for Empaveli in July for C3 glomerulopathy, Apellis has recorded 267 new patient start forms, indicating robust market demand and product acceptance.
- Payer Progress: Management reports no full denials to date, suggesting that Empaveli's broader label and superior efficacy compared to Novartis' Fabhalta have facilitated rapid market penetration.
- EU Approval Boost: Apellis' partner Sobi recently received EU approval for the drug against C3G and IC-MPGN, further enhancing Empaveli's competitive position in international markets.
- Growth Potential: With the price target unchanged at $28 per share, analysts believe there is room for continued upside as momentum builds in the coming quarters.
See More
Sobi Secures EU Approval for Aspaveli in Rare Kidney Disorders
- Drug Approval: Swedish Orphan Biovitrum (Sobi) announced that its blood disorder therapy Aspaveli received approval from the European Commission, allowing it to treat patients aged 12-17 with C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis, estimated to affect up to 8,000 patients in Europe, significantly expanding its market share in the rare disease sector.
- Market Collaboration: Aspaveli is marketed in collaboration with Apellis Pharmaceuticals, whose Empaveli generated $67.3 million in net product revenue during the first nine months of 2025, indicating the market potential and commercial value of the drug in treating related conditions.
- Regulatory Consistency: The approval aligns with the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December, reflecting regulatory recognition of Aspaveli's efficacy and laying a foundation for Sobi's further development in the European market.
- Strategic Implications: By securing approval for Aspaveli, Sobi not only enhances its competitiveness in the rare kidney disease treatment space but also creates favorable opportunities for future market expansion and new product development, aligning with the company's long-term growth strategy.
See More
Wall Street Trades Cautiously as CPI Rises 2.7% Amid Weak Earnings Reports
- Stable Inflation Data: The Consumer Price Index (CPI) rose 2.7% year-over-year in December, matching both prior readings and economist expectations, indicating that inflationary pressures remain stable and potentially supporting future Federal Reserve rate cuts.
- Silver Price Surge: Supply concerns drove silver prices up 4.5% to $89 per ounce, marking a 22% increase since the start of the year, reflecting strong market demand and heightened risk aversion among investors.
- Major Indices Performance: By midday, the S&P 500 index remained flat at 6,970, close to the record high of 6,986 set the previous day, while the Dow Jones Industrial Average fell 0.5%, indicating cautious market sentiment.
- Stock Movements: Despite JPMorgan Chase (JPM) beating earnings estimates, its stock fell over 3%, reflecting investor concerns over weak investment banking fees, while Moderna (MRNA) surged 14% due to bullish growth forecasts in its vaccine business, highlighting a preference for biotech stocks in the current market environment.
See More
Telsey Raises Five Below Inc Price Target to $240
- Price Target Increase: Telsey Advisory Group raised the price target for Five Below Inc from $195 to $240, with analyst Joseph Feldman maintaining an Outperform rating, indicating strong confidence in the company's future growth prospects.
- Rating Maintained: Despite HC Wainwright & Co. cutting Lexeo Therapeutics Inc's price target from $13 to $10, analyst Mitchell S. Kapoor maintained a Buy rating, reflecting optimism about its long-term potential.
- Price Target Cut: Needham reduced the price target for Apellis Pharmaceuticals Inc from $29 to $28, yet analyst Joseph Stringer upheld a Buy rating, demonstrating ongoing confidence in the company's fundamentals.
- Rating Downgrade: Daiwa Capital lowered PayPal Holdings Inc's price target from $77 to $61 and downgraded the rating from Outperform to Neutral, indicating a cautious outlook on its future performance.
See More
