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We issued an updated report on Apellis Pharmaceuticals, Inc. (APLS - Free Report) on Dec 24.
The company’s lead pipeline candidate, pegcetacoplan, is being developed for subcutaneous administration in several indications.
A phase III (PEGASUS) study comparing pegcetacoplan monotherapy to Alexion’s PNT drug, Soliris, in patients with paroxysmal nocturnal hemoglobinuria (PNH) is ongoing. The company reported positive 48-week top-line data in December 2020. The PEGASUS study demonstrated sustained hematological and clinical improvements in patients with PNH who were treated with pegcetacoplan, an investigational, targeted C3 therapy. The safety profile of pegcetacoplan was consistent with previously reported data and no new safety signals were identified.
Shares of the company have increased 81.1% year to date compared with the industry’s growth of 10.3%.
In September 2020, Apellis submitted a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for pegcetacoplan for the treatment of PNH based on results from the PEGASUS study. The EMA validated the MAA in October 2020 and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in 2021. In November 2020, the FDA accepted the NDA for pegcetacoplan for the treatment of PNH and granted Priority Review designation. The FDA set an action date of May 14, 2021, and stated that it does not currently intend to hold an advisory committee meeting to discuss the application.
Two phase III studies (DERBY and OAKS) evaluating pegcetacoplan in patients with GA are ongoing and the company expects to announce data from these studies in the third quarter of 2021. In a phase II study of pegcetacoplan in patients with GA, the treatment with the drug resulted in a significant reduction in the rate of geographic atrophy in age-related macular (GA) lesion growth over 12 months. No treatments exist for thissevere late-stage disease and if pegcetacoplan is approved to treat this disease, it can bring in significant revenues for the company.
Pegcetacoplan is also being evaluated in phase II studies for the treatment of cold agglutinin disease (CAD) and warm antibody autoimmune hemolyticanemia diseases. The company is also evaluating the candidate in phase II studies to treat four types of glomerular diseases, such as C3 glomerulopathy (C3G), IgA nephropathy, primary membranous nephropathy and lupus nephritis.
Apellis entered into a collaboration with Swedish Orphan Biovitrum AB (Sobi) for global co-development and ex-U.S. commercialization of systemic pegcetacoplan for up to $1.25 billion in payments plus tiered royalties ranging from high teens to high twenties. As part of the collaboration, the companies plan to start two new registrational programs in cold agglutinin disease (CAD) and hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA) in 2021. In November 2020, Apellis along with partner Sobi dosed the first patient in the phase II MERIDIAN study, which is evaluating pegcetacoplan in adult patients with sporadic amyotrophic lateral sclerosis (ALS), a neurological disease.
However, with no approved drug in its portfolio, any delay in the approval of pegcetacoplan will be a setback for the company. The company faces competition for pegcetacoplan. The principal competitors for PNH are Soliris (eculizumab) and Ultomiris (ravulizumab), which are C5 complement inhibitors developed and marketed by Alexion.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 70% year to date.
Alkermes’ earnings per share estimates have increased from 10 cents to 39 cents for 2020 and from 46 cents to 52 cents for 2021 over the past 60 days. Share price of the company has increased 4.2% year to date.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year. These 7 were selected because of their superior potential for immediate breakout.
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Apellis' (APLS) Pipeline Candidate Pegcetacoplan Promising
We issued an updated report on Apellis Pharmaceuticals, Inc. (APLS - Free Report) on Dec 24.
The company’s lead pipeline candidate, pegcetacoplan, is being developed for subcutaneous administration in several indications.
A phase III (PEGASUS) study comparing pegcetacoplan monotherapy to Alexion’s PNT drug, Soliris, in patients with paroxysmal nocturnal hemoglobinuria (PNH) is ongoing. The company reported positive 48-week top-line data in December 2020. The PEGASUS study demonstrated sustained hematological and clinical improvements in patients with PNH who were treated with pegcetacoplan, an investigational, targeted C3 therapy. The safety profile of pegcetacoplan was consistent with previously reported data and no new safety signals were identified.
Shares of the company have increased 81.1% year to date compared with the industry’s growth of 10.3%.
In September 2020, Apellis submitted a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for pegcetacoplan for the treatment of PNH based on results from the PEGASUS study. The EMA validated the MAA in October 2020 and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in 2021. In November 2020, the FDA accepted the NDA for pegcetacoplan for the treatment of PNH and granted Priority Review designation. The FDA set an action date of May 14, 2021, and stated that it does not currently intend to hold an advisory committee meeting to discuss the application.
Two phase III studies (DERBY and OAKS) evaluating pegcetacoplan in patients with GA are ongoing and the company expects to announce data from these studies in the third quarter of 2021. In a phase II study of pegcetacoplan in patients with GA, the treatment with the drug resulted in a significant reduction in the rate of geographic atrophy in age-related macular (GA) lesion growth over 12 months. No treatments exist for thissevere late-stage disease and if pegcetacoplan is approved to treat this disease, it can bring in significant revenues for the company.
Pegcetacoplan is also being evaluated in phase II studies for the treatment of cold agglutinin disease (CAD) and warm antibody autoimmune hemolyticanemia diseases. The company is also evaluating the candidate in phase II studies to treat four types of glomerular diseases, such as C3 glomerulopathy (C3G), IgA nephropathy, primary membranous nephropathy and lupus nephritis.
Apellis entered into a collaboration with Swedish Orphan Biovitrum AB (Sobi) for global co-development and ex-U.S. commercialization of systemic pegcetacoplan for up to $1.25 billion in payments plus tiered royalties ranging from high teens to high twenties. As part of the collaboration, the companies plan to start two new registrational programs in cold agglutinin disease (CAD) and hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA) in 2021. In November 2020, Apellis along with partner Sobi dosed the first patient in the phase II MERIDIAN study, which is evaluating pegcetacoplan in adult patients with sporadic amyotrophic lateral sclerosis (ALS), a neurological disease.
However, with no approved drug in its portfolio, any delay in the approval of pegcetacoplan will be a setback for the company. The company faces competition for pegcetacoplan. The principal competitors for PNH are Soliris (eculizumab) and Ultomiris (ravulizumab), which are C5 complement inhibitors developed and marketed by Alexion.
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. and Alkermes Plc. (ALKS - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 70% year to date.
Alkermes’ earnings per share estimates have increased from 10 cents to 39 cents for 2020 and from 46 cents to 52 cents for 2021 over the past 60 days. Share price of the company has increased 4.2% year to date.
Apellis Pharmaceuticals, Inc. Price
Apellis Pharmaceuticals, Inc. price | Apellis Pharmaceuticals, Inc. Quote
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