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Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced that the FDA has accepted its new drug application (“NDA”) seeking approval for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”).
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Nov 26, 2022. Currently, the FDA is not planning to hold an advisory committee meeting to discuss the above application.
A priority review designation is granted to drugs the FDA considers potent in providing significant improvements in the effective and safe prevention, diagnosis or treatment of a severe disease.
Pegcetacoplan also enjoys a Fast Track designation for the treatment of GA secondary to AMD.
The above-mentioned NDA was based on data from two phase III studies — DERBY and OAKS — at 12 and 18 months, as well as data from the phase II FILLY study at 12 months. Data from these studies showed that treatment with both monthly and every-other-month pegcetacoplan led to a clinically meaningful reduction of GA lesion growth across a broad heterogenous patient population.
Also, pegcetacoplan demonstrated a favorable safety profile in all three studies.
Shares of Apellis were up 16.3% following the announcement of the news on Tuesday. The stock has rallied 10.1% so far this year against the industry’s decline of 22.3%.
Image Source: Zacks Investment Research
In June 2022, APLS filed the NDA for pegcetacoplan to treat GA secondary to AMD.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed in the second half of 2022 to the European Medicines Agency.
In May 2021, the FDA approved pegcetacoplan (marketed as Empaveli) as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria (“PNH”).
Empaveli is approved for treatment-naïve patients and for those switching from Alexion’s (now part of AstraZeneca) C5 inhibitor therapies for PNH, namely Soliris and Ultomiris.
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.
Several label expansion studies on pegcetacoplan are currently underway. Upon potential approval for GA and additional indications will boost sales and drive growth for the company in the days ahead.
The Zacks Consensus Estimate for Anika Therapeutics’ loss per share has narrowed 14.4% for 2022 and 9.1% for 2023 in the past 60 days.
Earnings of Anika Therapeutics have surpassed estimates in each of the trailing three quarters. ANIK delivered an earnings surprise of 200.45%, on average.
Celldex Therapeutics’ loss per share estimates narrowed 0.5% for 2022 and 1.2% for 2023 in the past 60 days.
Earnings of Celldex Therapeutics have surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions. CLDX delivered an earnings surprise of -1.33%, on average.
Beam Therapeutics’ loss per share estimates narrowed 0.7% for 2022 and 0.8% for 2023 in the past 60 days.
Earnings of Beam Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. BEAM delivered an earnings surprise of 1.80%, on average.
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Apellis' (APLS) Geographic Atrophy NDA Gets Priority Review
Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced that the FDA has accepted its new drug application (“NDA”) seeking approval for its targeted C3 therapy, pegcetacoplan, for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”).
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Nov 26, 2022. Currently, the FDA is not planning to hold an advisory committee meeting to discuss the above application.
A priority review designation is granted to drugs the FDA considers potent in providing significant improvements in the effective and safe prevention, diagnosis or treatment of a severe disease.
Pegcetacoplan also enjoys a Fast Track designation for the treatment of GA secondary to AMD.
The above-mentioned NDA was based on data from two phase III studies — DERBY and OAKS — at 12 and 18 months, as well as data from the phase II FILLY study at 12 months. Data from these studies showed that treatment with both monthly and every-other-month pegcetacoplan led to a clinically meaningful reduction of GA lesion growth across a broad heterogenous patient population.
Also, pegcetacoplan demonstrated a favorable safety profile in all three studies.
Shares of Apellis were up 16.3% following the announcement of the news on Tuesday. The stock has rallied 10.1% so far this year against the industry’s decline of 22.3%.
Image Source: Zacks Investment Research
In June 2022, APLS filed the NDA for pegcetacoplan to treat GA secondary to AMD.
A marketing authorization application for pegcetacoplan to treat GA is expected to be filed in the second half of 2022 to the European Medicines Agency.
In May 2021, the FDA approved pegcetacoplan (marketed as Empaveli) as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria (“PNH”).
Empaveli is approved for treatment-naïve patients and for those switching from Alexion’s (now part of AstraZeneca) C5 inhibitor therapies for PNH, namely Soliris and Ultomiris.
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.
Several label expansion studies on pegcetacoplan are currently underway. Upon potential approval for GA and additional indications will 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). Better-ranked stocks in the biotech sector are Anika Therapeutics, Inc. (ANIK - Free Report) , Celldex Therapeutics, Inc. (CLDX - Free Report) and Beam Therapeutics Inc. (BEAM - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Anika Therapeutics’ loss per share has narrowed 14.4% for 2022 and 9.1% for 2023 in the past 60 days.
Earnings of Anika Therapeutics have surpassed estimates in each of the trailing three quarters. ANIK delivered an earnings surprise of 200.45%, on average.
Celldex Therapeutics’ loss per share estimates narrowed 0.5% for 2022 and 1.2% for 2023 in the past 60 days.
Earnings of Celldex Therapeutics have surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions. CLDX delivered an earnings surprise of -1.33%, on average.
Beam Therapeutics’ loss per share estimates narrowed 0.7% for 2022 and 0.8% for 2023 in the past 60 days.
Earnings of Beam Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. BEAM delivered an earnings surprise of 1.80%, on average.