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Apellis Stock Rises on $300M Royalty Deal With Sobi for Aspaveli
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Key Takeaways
APLS stock rose 3.2% on a $300M capped royalty deal with Sobi for ex-U.S. sales of Aspaveli.
Apellis retains U.S. rights to Empaveli and gains near-term cash plus a potential $25M in milestone payments.
FDA and EU reviews are underway for the label expansion of pegcetacoplan for two rare kidney diseases.
Apellis Pharmaceuticals’ (APLS - Free Report) shares gained 3.2% on Tuesday following the announcement of a capped royalty deal with Sobi, under which Apellis will receive up to $300 million in return for 90% of its future ex-U.S. royalties from Aspaveli (systemic pegcetacoplan). The drug is currently approved in the EU and the United States for the treatment of paroxysmal nocturnal hemoglobinuria, a rare blood disorder.
The influx of cash significantly strengthens Apellis’ balance sheet and will provide the company with operational flexibility. APLS ended the first quarter of 2025 with cash, cash equivalents and marketable securities worth $358.4 million.
APLS’ Aspaveli Royalty Deal With Sobi in Detail
Under the agreement terms, Sobi will pay Apellis $275 million in cash for 90% of its ex-U.S. royalties from Aspaveli. Additionally, Apellis may earn up to $25 million in milestone payments upon EU approval of Aspaveli for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), two rare and severe kidney diseases.
The deal includes performance-based caps. Sobi will continue to receive 90% of ex-U.S. royalties until those caps are met, after which all ex-U.S. royalties will fully revert to Apellis.
Year to date, APLS shares have plunged 44% compared with the industry’s decline of 3.4%.
Image Source: Zacks Investment Research
The companies originally signed a licensing deal in 2020, under which Apellis granted Sobi exclusive rights to develop and market Aspaveli in all countries outside of the United States. Per the 2020 agreement, APLS is entitled to receive royalties on ex-U.S. sales of Aspaveli ranging from the high teens to the high twenties. In the United States, Apellis retains exclusive commercialization rights for systemic pegcetacoplan, where it is marketed as Empaveli.
APLS Seeking Label Expansion for Aspaveli/Empaveli
Apellis and Sobi’s supplemental new drug application seeking the label expansion of Empaveli for C3G and IC-MPGN is currently being reviewed by the FDA under the Priority Review pathway. A decision is expected on July 28, 2025. A similar regulatory filing by Sobi is also currently under review by the regulatory body in the EU, with a decision expected by year-end.
The regulatory applications are based on positive results from the phase III VALIANT study evaluating the drug in C3G and IC-MPGN patients.
Per the data readout, the study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful 68% proteinuria reduction in C3G and IC-MPGN patients treated with Empaveli compared to placebo, both in addition to background therapy, at week 26. The reported results were consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys.
Additionally, it was observed that patients treated with the drug experienced stabilized kidney function, as indicated by estimated glomerular filtration rate measurements. A significant number of Empaveli-treated patients demonstrated a decrease in C3c staining intensity, with 71% achieving complete clearance compared to the placebo group.
In the VALIANT study, the drug was overall well-tolerated with a consistent safety profile. Adverse events were mostly mild to moderate in severity.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.44 to 70 cents. Loss per share estimates for 2026 have narrowed from $1.45 to $1.08 during the same period. IMCR stock has gained 11.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
In the past 90 days, Verona Pharma’s bottom-line estimates for 2025 have significantly improved from a loss of 7 cents per share to earnings of 22 cents. During the same timeframe, estimates for 2026 earnings per share have improved from $2.21 to $2.88. VRNA stock has soared 94.8% so far this year.
Verona Pharma’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, delivering an average negative surprise of 6.76%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has surged 76.6% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
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Apellis Stock Rises on $300M Royalty Deal With Sobi for Aspaveli
Key Takeaways
Apellis Pharmaceuticals’ (APLS - Free Report) shares gained 3.2% on Tuesday following the announcement of a capped royalty deal with Sobi, under which Apellis will receive up to $300 million in return for 90% of its future ex-U.S. royalties from Aspaveli (systemic pegcetacoplan). The drug is currently approved in the EU and the United States for the treatment of paroxysmal nocturnal hemoglobinuria, a rare blood disorder.
The influx of cash significantly strengthens Apellis’ balance sheet and will provide the company with operational flexibility. APLS ended the first quarter of 2025 with cash, cash equivalents and marketable securities worth $358.4 million.
APLS’ Aspaveli Royalty Deal With Sobi in Detail
Under the agreement terms, Sobi will pay Apellis $275 million in cash for 90% of its ex-U.S. royalties from Aspaveli. Additionally, Apellis may earn up to $25 million in milestone payments upon EU approval of Aspaveli for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), two rare and severe kidney diseases.
The deal includes performance-based caps. Sobi will continue to receive 90% of ex-U.S. royalties until those caps are met, after which all ex-U.S. royalties will fully revert to Apellis.
Year to date, APLS shares have plunged 44% compared with the industry’s decline of 3.4%.
Image Source: Zacks Investment Research
The companies originally signed a licensing deal in 2020, under which Apellis granted Sobi exclusive rights to develop and market Aspaveli in all countries outside of the United States. Per the 2020 agreement, APLS is entitled to receive royalties on ex-U.S. sales of Aspaveli ranging from the high teens to the high twenties. In the United States, Apellis retains exclusive commercialization rights for systemic pegcetacoplan, where it is marketed as Empaveli.
APLS Seeking Label Expansion for Aspaveli/Empaveli
Apellis and Sobi’s supplemental new drug application seeking the label expansion of Empaveli for C3G and IC-MPGN is currently being reviewed by the FDA under the Priority Review pathway. A decision is expected on July 28, 2025. A similar regulatory filing by Sobi is also currently under review by the regulatory body in the EU, with a decision expected by year-end.
The regulatory applications are based on positive results from the phase III VALIANT study evaluating the drug in C3G and IC-MPGN patients.
Per the data readout, the study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful 68% proteinuria reduction in C3G and IC-MPGN patients treated with Empaveli compared to placebo, both in addition to background therapy, at week 26. The reported results were consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys.
Additionally, it was observed that patients treated with the drug experienced stabilized kidney function, as indicated by estimated glomerular filtration rate measurements. A significant number of Empaveli-treated patients demonstrated a decrease in C3c staining intensity, with 71% achieving complete clearance compared to the placebo group.
In the VALIANT study, the drug was overall well-tolerated with a consistent safety profile. Adverse events were mostly mild to moderate in severity.
Apellis Pharmaceuticals, Inc. Price and Consensus
Apellis Pharmaceuticals, Inc. price-consensus-chart | Apellis Pharmaceuticals, Inc. Quote
APLS’ Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Verona Pharma (VRNA - Free Report) and Agenus (AGEN - Free Report) . While IMCR and VRNA sport a Zacks Rank #1 (Strong Buy) each, AGEN carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.44 to 70 cents. Loss per share estimates for 2026 have narrowed from $1.45 to $1.08 during the same period. IMCR stock has gained 11.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
In the past 90 days, Verona Pharma’s bottom-line estimates for 2025 have significantly improved from a loss of 7 cents per share to earnings of 22 cents. During the same timeframe, estimates for 2026 earnings per share have improved from $2.21 to $2.88. VRNA stock has soared 94.8% so far this year.
Verona Pharma’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, delivering an average negative surprise of 6.76%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has surged 76.6% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.