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Alnylam's (ALNY) Zilebesiran Meets Goals in Mid-Stage Study
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Alnylam Pharmaceuticals (ALNY - Free Report) announced positive top-line results from its mid-stage study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen in development for the treatment of hypertension in patients at high cardiovascular risk.
Alnylam is developing zilebesiran in partnership with Roche (RHHBY - Free Report) . The two-pronged phase II KARDIA program is currently evaluating the safety and efficacy of zilebesiran, either as a monotherapy (KARDIA-1) or in combination with one of three standard-of-care antihypertensive medications (KARDIA-2).
The KARDIA-1 phase II dose-ranging study is evaluating the efficacy and safety of zilebesiran as monotherapy in adults with mild-to-moderate hypertension. The study enrolled 394 adult patients who were randomly divided into five treatment arms. Each patient received either a subcutaneous biannual dose of zilebesiran (150 mg, 300 mg or 600 mg), a subcutaneous quarterly 300 mg dose of zilebesiran or placebo.
Per the data readout from the KARDIA-1 study, the primary endpoint of dose-dependent, clinically significant reduction in 24-hour mean systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) at month three, compared with treatment with placebo, was achieved with both 300 mg and 600 mg doses.
The company also reported meeting key secondary endpoints in the study, including a significant change in 24-hour mean SBP as measured by ABPM at month six, as well as a significant change in office SBP at month three and month six, for all zilebesiran arms, compared with placebo.
The encouraging results from the KARDIA-1 study reaffirm the effectiveness of zilebesiran in treating hypertension in patients at high cardiovascular risk. Alnylam further stated that the candidate demonstrated an encouraging safety and tolerability profile that supports continued development.
Year to date, shares of Alnylam have lost 15.4% compared with the industry’s 13.8% fall.
Image Source: Zacks Investment Research
Per Alnylam, the robust data from the study will help determine the optimal dose and regimen of zilebesiran for future studies.
Despite encouraging results, there was one reported case of death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the study drug. Adverse events due to treatment with zilebesiran were minimal.
In the press release, Alnylam also reported that the phase II KARDIA-2 study completed enrollment in June 2023, expecting top-line results in early 2024.
We would like to remind the investors that Alnylam announced entering into a strategic collaboration with Roche to co-develop and co-commercialize zilebesiran for the treatment of hypertension in July 2023.
Per ALNY, Roche is a well-suited partner for the development of zilebesiran with its expertise in developing and commercializing novel therapies in complex markets. The agreement also provides Alnylam access to Roche’s abundant resources and global infrastructure. The company expects that the partnership with RHHBY could potentially enable zilebesiran to reach more patients with hypertension.
Under the terms of the agreement, ALNY received an upfront cash payment of $310 million from Roche. Alnylam is also eligible to receive additional payments from Roche upon the fulfillment of certain developmental, regulatory and sales-based milestones, amounting to a potential deal value of up to $2.8 billion.
The agreement also grants Alnylam an equal profit share in the United States, where ALNY and RHHBY will co-commercialize zilebesiran. Outside the United States, the deal grants Roche exclusive right to commercialize zilebesiran, in exchange for low double-digit royalty payments to Alnylam on net sales of zilebesiran, in its territory.
A few better-ranked stocks in the same industry are Dynavax Technologies (DVAX - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 29.4%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has narrowed from $1.33 to $1.28. During the same period, Better Therapeutics’ 2024 loss per share has also narrowed from 83 cents to 80 cents. Year to date, shares of BTTX have lost 44.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
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Alnylam's (ALNY) Zilebesiran Meets Goals in Mid-Stage Study
Alnylam Pharmaceuticals (ALNY - Free Report) announced positive top-line results from its mid-stage study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen in development for the treatment of hypertension in patients at high cardiovascular risk.
Alnylam is developing zilebesiran in partnership with Roche (RHHBY - Free Report) . The two-pronged phase II KARDIA program is currently evaluating the safety and efficacy of zilebesiran, either as a monotherapy (KARDIA-1) or in combination with one of three standard-of-care antihypertensive medications (KARDIA-2).
The KARDIA-1 phase II dose-ranging study is evaluating the efficacy and safety of zilebesiran as monotherapy in adults with mild-to-moderate hypertension. The study enrolled 394 adult patients who were randomly divided into five treatment arms. Each patient received either a subcutaneous biannual dose of zilebesiran (150 mg, 300 mg or 600 mg), a subcutaneous quarterly 300 mg dose of zilebesiran or placebo.
Per the data readout from the KARDIA-1 study, the primary endpoint of dose-dependent, clinically significant reduction in 24-hour mean systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) at month three, compared with treatment with placebo, was achieved with both 300 mg and 600 mg doses.
The company also reported meeting key secondary endpoints in the study, including a significant change in 24-hour mean SBP as measured by ABPM at month six, as well as a significant change in office SBP at month three and month six, for all zilebesiran arms, compared with placebo.
The encouraging results from the KARDIA-1 study reaffirm the effectiveness of zilebesiran in treating hypertension in patients at high cardiovascular risk. Alnylam further stated that the candidate demonstrated an encouraging safety and tolerability profile that supports continued development.
Year to date, shares of Alnylam have lost 15.4% compared with the industry’s 13.8% fall.
Image Source: Zacks Investment Research
Per Alnylam, the robust data from the study will help determine the optimal dose and regimen of zilebesiran for future studies.
Despite encouraging results, there was one reported case of death due to cardiopulmonary arrest in a zilebesiran-treated patient that was considered unrelated to the study drug. Adverse events due to treatment with zilebesiran were minimal.
In the press release, Alnylam also reported that the phase II KARDIA-2 study completed enrollment in June 2023, expecting top-line results in early 2024.
We would like to remind the investors that Alnylam announced entering into a strategic collaboration with Roche to co-develop and co-commercialize zilebesiran for the treatment of hypertension in July 2023.
Per ALNY, Roche is a well-suited partner for the development of zilebesiran with its expertise in developing and commercializing novel therapies in complex markets. The agreement also provides Alnylam access to Roche’s abundant resources and global infrastructure. The company expects that the partnership with RHHBY could potentially enable zilebesiran to reach more patients with hypertension.
Under the terms of the agreement, ALNY received an upfront cash payment of $310 million from Roche. Alnylam is also eligible to receive additional payments from Roche upon the fulfillment of certain developmental, regulatory and sales-based milestones, amounting to a potential deal value of up to $2.8 billion.
The agreement also grants Alnylam an equal profit share in the United States, where ALNY and RHHBY will co-commercialize zilebesiran. Outside the United States, the deal grants Roche exclusive right to commercialize zilebesiran, in exchange for low double-digit royalty payments to Alnylam on net sales of zilebesiran, in its territory.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Alnylam currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks in the same industry are Dynavax Technologies (DVAX - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 29.4%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has narrowed from $1.33 to $1.28. During the same period, Better Therapeutics’ 2024 loss per share has also narrowed from 83 cents to 80 cents. Year to date, shares of BTTX have lost 44.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.