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Apellis (APLS) Falls on Second Negative CHMP Opinion for GA Drug
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Apellis Pharmaceuticals (APLS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the second time on the marketing authorization application (MAA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) in the EU. Despite this decision, there were several dissenting votes among CHMP members.
Apellis plans to request a re-examination of the opinion and anticipates a final decision in the fourth quarter of 2024. The negative opinion followed an Ad Hoc Expert Group meeting, where experts agreed that the size of GA lesions is an acceptable primary outcome measure for GA studies and that microperimetry is the best available functional measure for GA.
The company’s shares lost 7.6% following the news on Jun 28. Apellis is currently gearing up to promptly initiate the re-examination process to clinch a nod for the GA treatment in the EU by the year’s end.
We remind the investors that the CHMP had already once voted against the MAA for Syfovre to treat GA in January 2024, following which Apellis demanded a re-examination of the same with the EMA. However, in March 2024, the Court of Justice of the European Union (CJEU) issued a judgment that ruled on the organization of EMA’s expert groups, posing implications for the EMA's policy for handling competing interests of experts.
Based on the CJEU’s judgment, the EMA had reset the review of the Syfovre MAA for the GA indication to the last phase of the initial assessment (day 180) in April 2024. The latest review was conducted by the original rapporteurs, as previously specified.
Apellis had clarified that the decision to reset the Syfovre MAA review was strictly procedural in response to the CJEU judgment and did not imply any shortcoming in the submission package for the drug, which was intended to support the approval in the EU.
Year to date, shares of APLS have plunged 35.9% compared with the industry’s 6.3% decline.
Image Source: Zacks Investment Research
Please note that pegcetacoplan injection is currently approved in the United States under the brand name Syfovre for treating GA secondary to age-related macular degeneration.
Syfovre was approved by the FDA in February 2023 as the first and only treatment for GA secondary to AMD in the United States. It has the potential to be a best-in-class treatment for patients with GA, a disease that is the leading cause of blindness, affecting more than one million people in the United States and five million people worldwide.
The drug has witnessed robust initial uptake since its commercial launch in March 2023.Syfovre recorded sales of $137.5 million in the first quarter of 2024, which increased 20.3% sequentially, owing to continued strong demand, thereby driving revenues for the company. Apellis delivered more than 72,000 commercial vials and nearly 5,000 samples of Syfovre to doctors in the first quarter. As of Mar 31, 2024, the total number of drug doses delivered since launch was 250,000.
Marketing authorization seeking applications for intravitreal pegcetacoplan for the treatment of GA is currently under review in several other countries apart from the EU, with decisions expected in the current year. Potential approval of the drug in additional geographies will further boost the top line.
Apellis also currently markets pegcetacoplan under the brand name Empaveli/Aspaveli in the United States and EU as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria. The drug is also approved in several other geographies for the same indication.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 59.5%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 69.2%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 15.2%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
Image: Shutterstock
Apellis (APLS) Falls on Second Negative CHMP Opinion for GA Drug
Apellis Pharmaceuticals (APLS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the second time on the marketing authorization application (MAA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) in the EU. Despite this decision, there were several dissenting votes among CHMP members.
Apellis plans to request a re-examination of the opinion and anticipates a final decision in the fourth quarter of 2024. The negative opinion followed an Ad Hoc Expert Group meeting, where experts agreed that the size of GA lesions is an acceptable primary outcome measure for GA studies and that microperimetry is the best available functional measure for GA.
The company’s shares lost 7.6% following the news on Jun 28. Apellis is currently gearing up to promptly initiate the re-examination process to clinch a nod for the GA treatment in the EU by the year’s end.
We remind the investors that the CHMP had already once voted against the MAA for Syfovre to treat GA in January 2024, following which Apellis demanded a re-examination of the same with the EMA. However, in March 2024, the Court of Justice of the European Union (CJEU) issued a judgment that ruled on the organization of EMA’s expert groups, posing implications for the EMA's policy for handling competing interests of experts.
Based on the CJEU’s judgment, the EMA had reset the review of the Syfovre MAA for the GA indication to the last phase of the initial assessment (day 180) in April 2024. The latest review was conducted by the original rapporteurs, as previously specified.
Apellis had clarified that the decision to reset the Syfovre MAA review was strictly procedural in response to the CJEU judgment and did not imply any shortcoming in the submission package for the drug, which was intended to support the approval in the EU.
Year to date, shares of APLS have plunged 35.9% compared with the industry’s 6.3% decline.
Image Source: Zacks Investment Research
Please note that pegcetacoplan injection is currently approved in the United States under the brand name Syfovre for treating GA secondary to age-related macular degeneration.
Syfovre was approved by the FDA in February 2023 as the first and only treatment for GA secondary to AMD in the United States. It has the potential to be a best-in-class treatment for patients with GA, a disease that is the leading cause of blindness, affecting more than one million people in the United States and five million people worldwide.
The drug has witnessed robust initial uptake since its commercial launch in March 2023.Syfovre recorded sales of $137.5 million in the first quarter of 2024, which increased 20.3% sequentially, owing to continued strong demand, thereby driving revenues for the company. Apellis delivered more than 72,000 commercial vials and nearly 5,000 samples of Syfovre to doctors in the first quarter. As of Mar 31, 2024, the total number of drug doses delivered since launch was 250,000.
Marketing authorization seeking applications for intravitreal pegcetacoplan for the treatment of GA is currently under review in several other countries apart from the EU, with decisions expected in the current year. Potential approval of the drug in additional geographies will further boost the top line.
Apellis also currently markets pegcetacoplan under the brand name Empaveli/Aspaveli in the United States and EU as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria. The drug is also approved in several other geographies for the same indication.
Zacks Rank and Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) , 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 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 59.5%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 69.2%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 15.2%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.