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Apellis (APLS) Files MAA for Pegcetacoplan in GA in Europe
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Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced that it has submitted a marketing authorization application (“MAA”) to the European Medicines Agency seeking approval for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”), a leading cause of blindness.
If approved in Europe, pegcetacoplan will become the first and only treatment for GA to be available in the country.
The MAA was based on data from the phase III DERBY and the phase III OAKS studies, which evaluated pegcetacoplan for treating GA secondary to AMD. Data from these studies showed that treatment with both monthly and every-other-month pegcetacoplan led to a robust and clinically meaningful reduction of GA lesion growth.
Treatment with pegcetacoplan demonstrated a favorable safety profile.
Shares of Apellis have rallied 12.1% so far this year against the industry’s decline of 19.7%.
Image Source: Zacks Investment Research
Last month, the FDA accepted Apellis’ unsolicited major amendment to the new drug application (“NDA”) for pegcetacoplan, for the treatment of GA secondary to AMD.
A decision from the regulatory body is now expected on Feb 26, 2023. Shares of APLS rose on this news.
In July 2022, the FDA accepted and granted priority review to the NDA for pegcetacoplan to treat GA secondary to AMD. A decision from the regulatory body was expected on Nov 26, 2022. However, the latest major amendment to the NDA for pegcetacoplan extended the review period by three months.
In May 2021, the FDA approved pegcetacoplan (marketed as Empaveli) as a monotherapy treatment for adult patients suffering from PNH.
Empaveli is approved for treatment-naïve patients and those switching from Alexion’s [now part of AstraZeneca (AZN - Free Report) ] C5 inhibitor therapies for PNH, namely Soliris and Ultomiris.
AZN closed the acquisition of rare-disease drugmaker Alexion for $39 billion in July 2021, strengthening its immunology franchise.
The European Commission approved pegcetacoplan (marketed as Aspaveli) to treat adult patients with PNH who are anemic after treatment with a C5 inhibitor for at least three months in December 2021.
In the first nine months of 2022, Empaveli/Aspaveli generated sales worth $45.4 million.
Several label expansion studies on pegcetacoplan are currently underway. Potential approval for GA and additional indications is likely to boost sales and drive growth for the company in the days ahead.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 7.7% for 2022 and 7.4% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Immunocore have narrowed 56.8% for 2022 and 58.5% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
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Apellis (APLS) Files MAA for Pegcetacoplan in GA in Europe
Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced that it has submitted a marketing authorization application (“MAA”) to the European Medicines Agency seeking approval for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”), a leading cause of blindness.
If approved in Europe, pegcetacoplan will become the first and only treatment for GA to be available in the country.
The MAA was based on data from the phase III DERBY and the phase III OAKS studies, which evaluated pegcetacoplan for treating GA secondary to AMD. Data from these studies showed that treatment with both monthly and every-other-month pegcetacoplan led to a robust and clinically meaningful reduction of GA lesion growth.
Treatment with pegcetacoplan demonstrated a favorable safety profile.
Shares of Apellis have rallied 12.1% so far this year against the industry’s decline of 19.7%.
Image Source: Zacks Investment Research
Last month, the FDA accepted Apellis’ unsolicited major amendment to the new drug application (“NDA”) for pegcetacoplan, for the treatment of GA secondary to AMD.
A decision from the regulatory body is now expected on Feb 26, 2023. Shares of APLS rose on this news.
In July 2022, the FDA accepted and granted priority review to the NDA for pegcetacoplan to treat GA secondary to AMD. A decision from the regulatory body was expected on Nov 26, 2022. However, the latest major amendment to the NDA for pegcetacoplan extended the review period by three months.
In May 2021, the FDA approved pegcetacoplan (marketed as Empaveli) as a monotherapy treatment for adult patients suffering from PNH.
Empaveli is approved for treatment-naïve patients and those switching from Alexion’s [now part of AstraZeneca (AZN - Free Report) ] C5 inhibitor therapies for PNH, namely Soliris and Ultomiris.
AZN closed the acquisition of rare-disease drugmaker Alexion for $39 billion in July 2021, strengthening its immunology franchise.
The European Commission approved pegcetacoplan (marketed as Aspaveli) to treat adult patients with PNH who are anemic after treatment with a C5 inhibitor for at least three months in December 2021.
In the first nine months of 2022, Empaveli/Aspaveli generated sales worth $45.4 million.
Several label expansion studies on pegcetacoplan are currently underway. Potential approval for GA and additional indications is likely to boost sales and drive growth for the company in the days ahead.
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited (ASLN - Free Report) and Immunocore Holdings plc (IMCR - 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.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 7.7% for 2022 and 7.4% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Immunocore have narrowed 56.8% for 2022 and 58.5% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.