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Apellis (APLS) Plunges on Safety Issues With Eye Treatment
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Shares of Apellis Pharmaceuticals, Inc. (APLS - Free Report) crashed 52.6% in two days after the company received reports of retinal vasculitis (or inflammation) following treatment with Syfovre (pegcetacoplan injection). Shares were down 23.75% on Jul 18.
We remind investors that the FDA approved Syfovre for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on Feb 17, 2023.
The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee collaborated with Apellis Pharmaceuticals to investigate the reported retinal vasculitis events. Out of the six reported cases, two were confirmed as occlusive, one as non-occlusive and the remaining three were undetermined due to limited information. These events occurred between 7 and 13 days after the initial administration of Syfovre, with no specific lots implicated.
The company, in close coordination with external experts and the ReST Committee, is conducting a thorough investigation into each event. Apellis Pharmaceuticals has followed up with the FDA and provided detailed information on these cases. The FDA has not recommended any immediate action in response to the reports.
The reported vasculitis events occurred at an estimated rate of 0.01% per injection, or approximately 1 in 10,000 injections. Per the company, approximately 60,000 vials of Syfovre have been distributed since approval. Apellis stated that there were no instances of retinal vasculitis reported during the clinical trials, which involved more than 23,000 injections.
The stock price decline reflects the uncertainties surrounding the safety profile and potential risks associated with Syfovre. The outcome of the investigation and subsequent actions taken by the FDA will play a crucial role in shaping the prospects of the drug. Depending on the findings, the company may need to address safety concerns and modify its treatment protocols.
Apellis’ shares have lost 23.2% in the past 12 months compared with the industry's 8.4% decline.
Image Source: Zacks Investment Research
A marketing authorization application seeking approval of intravitreal pegcetacoplan for treating GA is currently under review by the European Medicines Agency. A decision regarding the same is expected in early 2024.
Apellis’ first marketed product, Empaveli (pegcetacoplan) is approved as a monotherapy treatment for adults suffering from paroxysmal nocturnal hemoglobinuria.
The company also suffered a setback in May 2023 after the mid-stage MERIDIAN study investigating systemic pegcetacoplan for the treatment of amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival rank score at week 52. The study also did not meet key secondary efficacy endpoints. Consequently, Apellis and partner Sobi plan to discontinue the development of systemic pegcetacoplan for ALS, based on the lack of efficacy.
In April, Apellis and Sobi discontinued treatment in the open-label portion of the study, following a recommendation from an independent data monitoring committee.
Zacks Rank & Other Stocks to Consider
Apellis currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the healthcare sector are Alkermes (ALKS - Free Report) and Anixa Biosciences (ANIX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
The Zacks Consensus Estimate for Alkermes’ 2023 earnings has increased from 20 cents to $1.02 in the past 60 days. Earnings estimates for 2024 have also increased from $1.73 to $2.08 in the past 60 days. ALKS beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
In the past 90 days, the consensus estimate for Anixa Biosciences 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for 2024 loss per share has narrowed from 46 cents to 38 cents. ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
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Apellis (APLS) Plunges on Safety Issues With Eye Treatment
Shares of Apellis Pharmaceuticals, Inc. (APLS - Free Report) crashed 52.6% in two days after the company received reports of retinal vasculitis (or inflammation) following treatment with Syfovre (pegcetacoplan injection). Shares were down 23.75% on Jul 18.
We remind investors that the FDA approved Syfovre for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on Feb 17, 2023.
The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee collaborated with Apellis Pharmaceuticals to investigate the reported retinal vasculitis events. Out of the six reported cases, two were confirmed as occlusive, one as non-occlusive and the remaining three were undetermined due to limited information. These events occurred between 7 and 13 days after the initial administration of Syfovre, with no specific lots implicated.
The company, in close coordination with external experts and the ReST Committee, is conducting a thorough investigation into each event. Apellis Pharmaceuticals has followed up with the FDA and provided detailed information on these cases. The FDA has not recommended any immediate action in response to the reports.
The reported vasculitis events occurred at an estimated rate of 0.01% per injection, or approximately 1 in 10,000 injections. Per the company, approximately 60,000 vials of Syfovre have been distributed since approval. Apellis stated that there were no instances of retinal vasculitis reported during the clinical trials, which involved more than 23,000 injections.
The stock price decline reflects the uncertainties surrounding the safety profile and potential risks associated with Syfovre. The outcome of the investigation and subsequent actions taken by the FDA will play a crucial role in shaping the prospects of the drug. Depending on the findings, the company may need to address safety concerns and modify its treatment protocols.
Apellis’ shares have lost 23.2% in the past 12 months compared with the industry's 8.4% decline.
Image Source: Zacks Investment Research
A marketing authorization application seeking approval of intravitreal pegcetacoplan for treating GA is currently under review by the European Medicines Agency. A decision regarding the same is expected in early 2024.
Apellis’ first marketed product, Empaveli (pegcetacoplan) is approved as a monotherapy treatment for adults suffering from paroxysmal nocturnal hemoglobinuria.
The company also suffered a setback in May 2023 after the mid-stage MERIDIAN study investigating systemic pegcetacoplan for the treatment of amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival rank score at week 52. The study also did not meet key secondary efficacy endpoints. Consequently, Apellis and partner Sobi plan to discontinue the development of systemic pegcetacoplan for ALS, based on the lack of efficacy.
In April, Apellis and Sobi discontinued treatment in the open-label portion of the study, following a recommendation from an independent data monitoring committee.
Zacks Rank & Other Stocks to Consider
Apellis currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the healthcare sector are Alkermes (ALKS - Free Report) and Anixa Biosciences (ANIX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2023 earnings has increased from 20 cents to $1.02 in the past 60 days. Earnings estimates for 2024 have also increased from $1.73 to $2.08 in the past 60 days. ALKS beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
In the past 90 days, the consensus estimate for Anixa Biosciences 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for 2024 loss per share has narrowed from 46 cents to 38 cents. ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.