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Apellis (APLS) Falls on Europe Update for Pegcetacoplan in GA
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Shares of Apellis Pharmaceuticals, Inc. (APLS - Free Report) were down 17% on Dec 14 after the company announced an update on the marketing authorization application (MAA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the EU.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is reviewing the MAA for intravitreal pegcetacoplan for the given indication. APLS expects the CHMP to adopt a negative opinion on the MAA for intravitreal pegcetacoplan at the upcoming meeting, which is expected to take place from Jan 22-25, 2024.
The company was earlier informed of a negative trend vote on the MAA for pegcetacoplan after the oral explanation meeting was held on Dec 13.
Though a negative opinion from the CHMP looks like a possibility now, Apellis still plans to work closely with the agency, appeal and seek a re-examination of the opinion.
Shares of Apellis have lost 1.4% in the past year compared with the industry’s decline of 17.7%.
Image Source: Zacks Investment Research
Pegcetacoplan injection was approved by the FDA for the treatment of GA secondary to AMD in February 2023. The medicine is marketed under the trade name Syfovre in the United States. It has witnessed a robust sales uptake so far, owing to continued strong demand.
However, a possible negative opinion from the CHMP is expected to delay the launch of the medicine in Europe and a potential loss of sales from this region for this indication.
Meanwhile, APLS is seeking to launch intravitreal pegcetacoplan in additional geographies. A marketing application seeking approval of intravitreal pegcetacoplan for the treatment of GA is also currently under review in several other countries. A decision on the same from regulatory bodies in other countries is expected in the first half of 2024.
In October 2023, APLS received the permanent J-code for Syfovre, which is likely to help the company streamline billing and reimbursement of the medicine.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. In the past year, shares of DERM have surged 340.7%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have decreased 34.4%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. In the past year, shares of PBYI have lost 20.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Apellis (APLS) Falls on Europe Update for Pegcetacoplan in GA
Shares of Apellis Pharmaceuticals, Inc. (APLS - Free Report) were down 17% on Dec 14 after the company announced an update on the marketing authorization application (MAA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the EU.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is reviewing the MAA for intravitreal pegcetacoplan for the given indication. APLS expects the CHMP to adopt a negative opinion on the MAA for intravitreal pegcetacoplan at the upcoming meeting, which is expected to take place from Jan 22-25, 2024.
The company was earlier informed of a negative trend vote on the MAA for pegcetacoplan after the oral explanation meeting was held on Dec 13.
Though a negative opinion from the CHMP looks like a possibility now, Apellis still plans to work closely with the agency, appeal and seek a re-examination of the opinion.
Shares of Apellis have lost 1.4% in the past year compared with the industry’s decline of 17.7%.
Pegcetacoplan injection was approved by the FDA for the treatment of GA secondary to AMD in February 2023. The medicine is marketed under the trade name Syfovre in the United States. It has witnessed a robust sales uptake so far, owing to continued strong demand.
However, a possible negative opinion from the CHMP is expected to delay the launch of the medicine in Europe and a potential loss of sales from this region for this indication.
Meanwhile, APLS is seeking to launch intravitreal pegcetacoplan in additional geographies. A marketing application seeking approval of intravitreal pegcetacoplan for the treatment of GA is also currently under review in several other countries. A decision on the same from regulatory bodies in other countries is expected in the first half of 2024.
In October 2023, APLS received the permanent J-code for Syfovre, which is likely to help the company streamline billing and reimbursement of the medicine.
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Journey Medical Corporation (DERM - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. In the past year, shares of DERM have surged 340.7%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have decreased 34.4%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. In the past year, shares of PBYI have lost 20.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.