Yahoo Finance Apellis' (APLS) Study on Pegcetacoplan to Treat ALS Fails
Apellis Pharmaceuticals, Inc. APLS announced that the phase II MERIDIAN study evaluating pegcetacoplan for the treatment of amyotrophic lateral sclerosis (“ALS”) did not meet its primary endpoint of the Combined Assessment of Function and Survival rank score at week 52. The study also failed to meet its key secondary efficacy endpoints.
Consequently, Apellis and its partner, Sobi, intend to discontinue the development of systemic pegcetacoplan for ALS based on the lack of efficacy. The companies had already discontinued treatment in the open-label portion of the study in April 2023. The decision was based on an unblinded review of the available data by an independent data monitoring committee, which did not support the continuation of the treatment.
In the past year, shares of Apellis have shot up 99.9% against the industry’s 8.2% decline.
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ALS is a neurodegenerative disease that causes progressive muscle weakness and paralysis due to the death of nerve cells in the brain and spinal cord. ALS seriously affects the quality of life of patients suffering from it as it leads to the progressive loss of voluntary muscle movement required for speaking, walking, swallowing and breathing. Approximately 225,000 patients suffer from ALS worldwide, with no approved treatments that stop or reverse the progression of ALS to date.
Pegcetacoplan first received FDA approval in May 2021, for treating paroxysmal nocturnal hemoglobinuria (PNH), under the brand name Empaveli. In the European Union, pegcetacoplan is approved as Aspaveli for the treatment of adult patients with PNH who are anemic following treatment with a C5 inhibitor for at least three months.
In February 2023, Apellis received a second FDA approval for pegcetacoplan injection, the first and only approved therapy for geographic atrophy (GA). The drug is marketed under the brand name, Syfovre. It is designed to provide comprehensive control of the complement cascade, which is part of the body’s immune system. Syfovre is approved in the United States for treating GA secondary to age-related macular degeneration.
Apellis also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for intravitreal pegcetacoplan to treat GA. The EMA subsequently provided MAA validation and the application is under review.
Currently, pegcetacoplan is being studied in partnershipwith Sobi for systemic administration in treating several other indications as well.
The phase III VALIANT study of systemic pegcetacoplan for Immune complex membranoproliferative glomerulonephritis and C3 glomerulopathy is currently enrolling patients. Data from the study is anticipated in 2024.
Apellis’ partner, Sobi, is currently enrolling patients in its phase II study evaluating the efficacy and safety of systemic pegcetacoplan in patients with hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Data from this study is expected in 2024. Sobi is also currently enrolling patients for its phase III CASCADE study of systemic pegcetacoplan for cold agglutinin disease.
Apellis Pharmaceuticals, Inc. Price and Consensus
Apellis Pharmaceuticals, Inc. price-consensus-chart | Apellis Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Apellis currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics ALLO, Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.31. In the past year, shares of Allogene Therapeutics have fallen by 31.6%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the past year, shares of Akero Therapeutics have rallied by 395.6%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the past year, shares of ADMA Biologics have gained by 93.2%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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