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Alnylam (ALNY) Posts Upbeat Data From Alzheimer's Disease Study
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Alnylam Pharmaceuticals (ALNY - Free Report) announced updated positive interim analysis data from the ongoing single-ascending dose portion of its phase I study of ALN-APP.
ALN-APP is the company’s investigational RNAi therapeutic targeting amyloid precursor protein, which is being developed to treat Alzheimer’s disease (AD) and cerebral amyloid angiopathy. The interim analysis results were reportedly presented at an ongoing medical conference. Alnylam is developing ALN-APP in collaboration with Regeneron Pharmaceuticals, Inc. (REGN - Free Report) .
It is important to note that in 2019, Alnylam and Regeneron entered into a global and strategic collaboration agreement, to co-develop and co-commercialize RNAi therapeutics for a broad range of eye and central nervous system (CNS) diseases. Following the initial agreement, in July 2020, Regeneron exercised its co-development/co-commercialization option on Alnylam’s first central nervous system targeted development candidate, ALN-APP.
However, the study on ALN-APP is being spearheaded by Alnylam. The company is also currently advancing multiple other programs with Regeneron. ALNY and REGN have named 10 targets in the CNS, in addition to ALN-APP, under its 2019 agreement.
Year to date, shares of Alnylam have declined 17% compared with the industry’s 9.9% fall.
Image Source: Zacks Investment Research
The phase I study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ALN-APP in patients with early-onset AD against treatment with placebo. The study consists of two parts, Part A and Part B. The Part A of the study is the single ascending dose phase and Part B forms the multiple-dose phase, in patients with early-onset AD. ALNY plans to enroll up to 60 patients in this early-stage study.
The Part A portion of the ongoing phase I study enrolled 20 patients in three single-dose cohorts. Per the data readout, it was observed that the single doses of ALN-APP, administered by intrathecal injection in the three cohorts, were well tolerated by the patients in the study so far.
Furthermore, no abnormalities were recorded in either the routine laboratory assessments of the patients or in preliminary data for the exploratory biomarker neurofilament light chain. The cohort of patients in Part A of the study, treated with a single dose of 75mg ALN-APP, experienced a rapid and sustained reduction in two cerebrospinal fluid (CSF) components, sAPPα and sAPPβ. These components form the biomarkers of target engagement in the study.
The Part A portion of the study is currently evaluating other single doses of ALN-APP. Additionally, Alnylam reported that the safety review committee has recommended the initiation of the multiple-dose Part B portion of the study. The Part B of the study will be enrolling patients from the Part A of the study. However, in the United States, the Part B portion of the study is currently on partial clinical hold on account of findings observed in prior non-clinical chronic toxicology studies.
To date, the safety and efficacy of ALN-APP have not been evaluated by the FDA, EMA or any other health authority.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics’ 2023 loss per share has widened from $2.58 to $2.61. During the same period, the estimate for ADC Therapeutics’ 2024 loss per share narrowed from $2.72 to $2.45. Year to date, shares of ADCT have lost 60.7%.
ADCT beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 46 cents to 38 cents. Year to date, shares of ANIX have lost 14.3%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
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Alnylam (ALNY) Posts Upbeat Data From Alzheimer's Disease Study
Alnylam Pharmaceuticals (ALNY - Free Report) announced updated positive interim analysis data from the ongoing single-ascending dose portion of its phase I study of ALN-APP.
ALN-APP is the company’s investigational RNAi therapeutic targeting amyloid precursor protein, which is being developed to treat Alzheimer’s disease (AD) and cerebral amyloid angiopathy. The interim analysis results were reportedly presented at an ongoing medical conference. Alnylam is developing ALN-APP in collaboration with Regeneron Pharmaceuticals, Inc. (REGN - Free Report) .
It is important to note that in 2019, Alnylam and Regeneron entered into a global and strategic collaboration agreement, to co-develop and co-commercialize RNAi therapeutics for a broad range of eye and central nervous system (CNS) diseases. Following the initial agreement, in July 2020, Regeneron exercised its co-development/co-commercialization option on Alnylam’s first central nervous system targeted development candidate, ALN-APP.
However, the study on ALN-APP is being spearheaded by Alnylam. The company is also currently advancing multiple other programs with Regeneron. ALNY and REGN have named 10 targets in the CNS, in addition to ALN-APP, under its 2019 agreement.
Year to date, shares of Alnylam have declined 17% compared with the industry’s 9.9% fall.
Image Source: Zacks Investment Research
The phase I study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ALN-APP in patients with early-onset AD against treatment with placebo. The study consists of two parts, Part A and Part B. The Part A of the study is the single ascending dose phase and Part B forms the multiple-dose phase, in patients with early-onset AD. ALNY plans to enroll up to 60 patients in this early-stage study.
The Part A portion of the ongoing phase I study enrolled 20 patients in three single-dose cohorts. Per the data readout, it was observed that the single doses of ALN-APP, administered by intrathecal injection in the three cohorts, were well tolerated by the patients in the study so far.
Furthermore, no abnormalities were recorded in either the routine laboratory assessments of the patients or in preliminary data for the exploratory biomarker neurofilament light chain. The cohort of patients in Part A of the study, treated with a single dose of 75mg ALN-APP, experienced a rapid and sustained reduction in two cerebrospinal fluid (CSF) components, sAPPα and sAPPβ. These components form the biomarkers of target engagement in the study.
The Part A portion of the study is currently evaluating other single doses of ALN-APP. Additionally, Alnylam reported that the safety review committee has recommended the initiation of the multiple-dose Part B portion of the study. The Part B of the study will be enrolling patients from the Part A of the study. However, in the United States, the Part B portion of the study is currently on partial clinical hold on account of findings observed in prior non-clinical chronic toxicology studies.
To date, the safety and efficacy of ALN-APP have not been evaluated by the FDA, EMA or any other health authority.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank and Other Stocks to Consider
Alnylam currently has a Zacks Rank #2 (Buy).
A couple of other top-ranked stocks in the same industry are ADC Therapeutics (ADCT - Free Report) andAnixa Biosciences (ANIX - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics’ 2023 loss per share has widened from $2.58 to $2.61. During the same period, the estimate for ADC Therapeutics’ 2024 loss per share narrowed from $2.72 to $2.45. Year to date, shares of ADCT have lost 60.7%.
ADCT beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 46 cents to 38 cents. Year to date, shares of ANIX have lost 14.3%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.