Sobi Receives Positive CHMP Opinion for Aspaveli
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
0mins
Should l Buy APLS?
Source: NASDAQ.COM
Positive Opinion from EMA: Sobi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for Aspaveli (pegcetacoplan) to treat C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis in adults and adolescents.
Phase 3 Study Results: The recommendation is based on positive outcomes from the Phase 3 VALIANT study, which supports the efficacy of pegcetacoplan in the specified conditions.
Expected Approval Timeline: The European Commission is anticipated to make a decision on the approval by the first quarter of 2026.
Co-Development Rights: Sobi and Apellis Pharmaceuticals hold global co-development rights for systemic pegcetacoplan, indicating a collaborative effort in bringing this treatment to market.
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Analyst Views on APLS
Wall Street analysts forecast APLS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for APLS is 43.25 USD with a low forecast of 22.00 USD and a high forecast of 117.80 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
14 Analyst Rating
9 Buy
5 Hold
0 Sell
Moderate Buy
Current: 22.830
Low
22.00
Averages
43.25
High
117.80
Current: 22.830
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.
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- 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.
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- 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.
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- 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
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- 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
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- 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
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- 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
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- 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.
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