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Apellis (APLS) Rides on Syfovre to Fuel Growth Amid Rivalry
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Apellis Pharmaceuticals, Inc.'s (APLS - Free Report) newly marketed product, Syfovre (pegcetacoplan injection), was approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023. The medicine has witnessed a robust sales uptake in the United States so far, owing to continued strong demand.
A marketing authorization application seeking approval of intravitreal pegcetacoplan for the treatment of GA is currently under review in Europe and several other countries. A decision regarding the same from the European Medicines Agency is expected in early 2024, while those from regulatory bodies in other countries are expected in the first half of 2024.
The potential approval and successful launch of Syfovre in additional geographies will boost sales further for the medicine and should drive revenues for Apellis in 2024 and beyond.
Meanwhile, Apellis’ first-marketed drug, Empaveli (pegcetacoplan), has shown an encouraging trend since approval. The FDA approved the drug for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) in 2021. Empaveli is also approved in Europe under the brand name Aspaveli for the same indication. The drug continues to be one of the growth drivers for Apellis, with reported revenues of almost $66.6 million in the first nine months of 2023.
Shares of Apellis have rallied 19.1% year to date against the industry’s decline of 21.2%.
Image Source: Zacks Investment ResearchIn October 2023, the FDA approved the Empaveli Injector as a single-use, on-body device to enhance the self-administration of Empaveli. The injector aims to provide patients with greater mobility and convenience in managing PNH.
The Empaveli Injector is the first of its kind, offering a high-volume (20 ml), subcutaneous on-body drug delivery system that can simplify the process of self-administration. APLS expects the injector to drive product sales.
This apart, Apellis is currently enrolling patients in the phase III VALIANT study evaluating systemic pegcetacoplan for treating immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy. Data from the study is expected in third-quarter 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.
Though Syfovre and Empaveli are driving Apellis’ top line, the company faces stiff competition from other companies for its drugs.
Alnylam Pharmaceuticals (ALNY - Free Report) is developing cemdisiran, an RNAi therapeutic targeting C5, for the treatment of complement-mediated diseases.
ALNY’s cemdisiran is being evaluated in a mid-stage study. Several other companies are also developing pipeline candidates using complement inhibition for the treatment of PNH. A potential approval for these candidates is likely to pose a threat to Apellis’ marketed products.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 6 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 21 cents. Year to date, shares of CTMX have lost 11.9%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 11.3%.
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%, on average.
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Apellis (APLS) Rides on Syfovre to Fuel Growth Amid Rivalry
Apellis Pharmaceuticals, Inc.'s (APLS - Free Report) newly marketed product, Syfovre (pegcetacoplan injection), was approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023. The medicine has witnessed a robust sales uptake in the United States so far, owing to continued strong demand.
A marketing authorization application seeking approval of intravitreal pegcetacoplan for the treatment of GA is currently under review in Europe and several other countries. A decision regarding the same from the European Medicines Agency is expected in early 2024, while those from regulatory bodies in other countries are expected in the first half of 2024.
The potential approval and successful launch of Syfovre in additional geographies will boost sales further for the medicine and should drive revenues for Apellis in 2024 and beyond.
Meanwhile, Apellis’ first-marketed drug, Empaveli (pegcetacoplan), has shown an encouraging trend since approval. The FDA approved the drug for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) in 2021. Empaveli is also approved in Europe under the brand name Aspaveli for the same indication. The drug continues to be one of the growth drivers for Apellis, with reported revenues of almost $66.6 million in the first nine months of 2023.
Shares of Apellis have rallied 19.1% year to date against the industry’s decline of 21.2%.
Image Source: Zacks Investment ResearchIn October 2023, the FDA approved the Empaveli Injector as a single-use, on-body device to enhance the self-administration of Empaveli. The injector aims to provide patients with greater mobility and convenience in managing PNH.
The Empaveli Injector is the first of its kind, offering a high-volume (20 ml), subcutaneous on-body drug delivery system that can simplify the process of self-administration. APLS expects the injector to drive product sales.
This apart, Apellis is currently enrolling patients in the phase III VALIANT study evaluating systemic pegcetacoplan for treating immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy. Data from the study is expected in third-quarter 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.
Though Syfovre and Empaveli are driving Apellis’ top line, the company faces stiff competition from other companies for its drugs.
Alnylam Pharmaceuticals (ALNY - Free Report) is developing cemdisiran, an RNAi therapeutic targeting C5, for the treatment of complement-mediated diseases.
ALNY’s cemdisiran is being evaluated in a mid-stage study. Several other companies are also developing pipeline candidates using complement inhibition for the treatment of PNH. A potential approval for these candidates is likely to pose a threat to Apellis’ marketed products.
Apellis Pharmaceuticals, Inc. Price and Consensus
Apellis Pharmaceuticals, Inc. price-consensus-chart | Apellis Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. (CTMX - 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 CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 6 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 21 cents. Year to date, shares of CTMX have lost 11.9%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 11.3%.
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%, on average.