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Apellis' (APLS) Empaveli Aids Growth, Stiff Competition a Woe
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Apellis Pharmaceuticals, Inc. (APLS - Free Report) is making good progress with its lead drug, Empaveli (pegcetacoplan), which is approved by the FDA as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria (PNH). The company has seen a strong initial uptake of Empaveli since its approval in May 2021.
PNH is a rare blood disorder, which is associated with abnormally low hemoglobin levels as the disease destroys red blood cells.
Empaveli is approved for treatment-naïve patients as well as for those switching from Alexion’s [now part of AstraZeneca (AZN - Free Report) ] C5 inhibitor therapies for PNH, Soliris and Ultomiris.
AZN closed the acquisition of rare-disease drugmaker, Alexion, last July.
The buyout of Alexion strengthened AstraZeneca’s immunology franchise, adding several drugs that can boost its top line.
The European Commission approved Aspaveli (pegcetacoplan) for treating adult patients with PNH, who are anemic after treatment with a C5 inhibitor for at least three months in December 2021. The drug is marketed under the trade name Empaveli in the United States.
Shares of Apellis have rallied 23.1% so far this year against the industry’s decline of 27.6%.
Image Source: Zacks Investment Research
Additionally, Apellis is evaluating pegcetacoplan, its targeted C3 therapy for treating several other indications.
In July 2022, FDA accepted and granted priority review to APLS’ new drug application for pegcetacoplan for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration. A decision from the regulatory body is expected on Nov 26, 2022.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed later in 2022 to the European Medicines Agency.
The phase II MERIDIAN study is evaluating systemic pegcetacoplan for treating amyotrophic lateral sclerosis. Top-line data from the same is expected in mid-2023.
Potential label expansion of the drug for any of the above indications will boost the company’s top line.
Though Apellis has made steady progress so far with Empaveli, we are concerned about the lack of other candidates in the company’s pipeline. Due to the lack of a strong pipeline, the company is heavily dependent on Empaveli for growth. Any regulatory or developmental setback for the drug is likely to hurt the stock. Stiff competition in the target market also remains a headwind.
Achilles Therapeutics’ loss per share estimates narrowed 7.4% for 2022 and 9.5% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
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Apellis' (APLS) Empaveli Aids Growth, Stiff Competition a Woe
Apellis Pharmaceuticals, Inc. (APLS - Free Report) is making good progress with its lead drug, Empaveli (pegcetacoplan), which is approved by the FDA as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria (PNH). The company has seen a strong initial uptake of Empaveli since its approval in May 2021.
PNH is a rare blood disorder, which is associated with abnormally low hemoglobin levels as the disease destroys red blood cells.
Empaveli is approved for treatment-naïve patients as well as for those switching from Alexion’s [now part of AstraZeneca (AZN - Free Report) ] C5 inhibitor therapies for PNH, Soliris and Ultomiris.
AZN closed the acquisition of rare-disease drugmaker, Alexion, last July.
The buyout of Alexion strengthened AstraZeneca’s immunology franchise, adding several drugs that can boost its top line.
The European Commission approved Aspaveli (pegcetacoplan) for treating adult patients with PNH, who are anemic after treatment with a C5 inhibitor for at least three months in December 2021. The drug is marketed under the trade name Empaveli in the United States.
Shares of Apellis have rallied 23.1% so far this year against the industry’s decline of 27.6%.
Image Source: Zacks Investment Research
Additionally, Apellis is evaluating pegcetacoplan, its targeted C3 therapy for treating several other indications.
In July 2022, FDA accepted and granted priority review to APLS’ new drug application for pegcetacoplan for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration. A decision from the regulatory body is expected on Nov 26, 2022.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed later in 2022 to the European Medicines Agency.
The phase II MERIDIAN study is evaluating systemic pegcetacoplan for treating amyotrophic lateral sclerosis. Top-line data from the same is expected in mid-2023.
Potential label expansion of the drug for any of the above indications will boost the company’s top line.
Though Apellis has made steady progress so far with Empaveli, we are concerned about the lack of other candidates in the company’s pipeline. Due to the lack of a strong pipeline, the company is heavily dependent on Empaveli for growth. Any regulatory or developmental setback for the drug is likely to hurt the stock. Stiff competition in the target market also remains a headwind.
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Achilles Therapeutics plc (ACHL - Free Report) and Atara Biotherapeutics, Inc. (ATRA - Free Report) , both carrying a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 7.4% for 2022 and 9.5% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.