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Alnylam (ALNY) to Co-Develop Hypertension Drug With Roche
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced entering into a strategic collaboration with Roche (RHHBY - Free Report) to co-develop and co-commercialize zilebesiran for the treatment of hypertension.
Zilebesiran is Alnylam’s investigational, subcutaneously administered RNAi therapeutic targeting angiotensinogen, which is currently being studied in a mid-stage study.
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 will also provide 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, a disease that affects more than 1.2 billion patients globally.
Year to date, shares of Alnylam have fallen 15.8% compared with the industry’s 10% decline.
Image Source: Zacks Investment Research
Per the terms of the agreement, ALNY is entitled to receive an upfront cash payment of $310 million from RHHBY. 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.
The agreement also states that the company will be leading a joint clinical development plan with Roche for the first indication, which includes a cardiovascular outcomes trial before the submission of zilebesiran for regulatory approval. The cost of the development program will be shared 40% by Alnylam and 60% by Roche. RHHBY has the option to lead development for additional indications in the future.
Alnylam previously reported encouraging results from the phase I study of zilebesiran compared with placebo. In the study, patients treated with ≥200 mg single doses of zilebesiran experienced dose-dependent reductions in serum angiotensinogen. The treated patients achieved tonic blood pressure control with consistent and durable blood pressure reduction throughout a 24-hour period for six months after single doses of zilebesiran. The safety profile of the candidate was also acceptable for continuing development.
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). Alnylam believes that zilebesiran has the potential to be a best-in-disease treatment providing transformational benefit, especially to patients with hypertension at high cardiovascular risk.
Zilebesiran can also have potential effectiveness in additional cardiovascular indications with high unmet medical need. To date, the safety and efficacy of zilebesiran have not been established or evaluated by any regulatory body.
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 63%.
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 Acadia Pharmaceuticals’ 2023 loss per share has narrowed from 58 cents to 31 cents. The estimate for Acadia Pharmaceuticals’ 2024 earnings per share is pegged at 47 cents. Year to date, shares of ACAD have rallied 93.5%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average negative earnings surprise of 2.75%.
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Alnylam (ALNY) to Co-Develop Hypertension Drug With Roche
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced entering into a strategic collaboration with Roche (RHHBY - Free Report) to co-develop and co-commercialize zilebesiran for the treatment of hypertension.
Zilebesiran is Alnylam’s investigational, subcutaneously administered RNAi therapeutic targeting angiotensinogen, which is currently being studied in a mid-stage study.
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 will also provide 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, a disease that affects more than 1.2 billion patients globally.
Year to date, shares of Alnylam have fallen 15.8% compared with the industry’s 10% decline.
Image Source: Zacks Investment Research
Per the terms of the agreement, ALNY is entitled to receive an upfront cash payment of $310 million from RHHBY. 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.
The agreement also states that the company will be leading a joint clinical development plan with Roche for the first indication, which includes a cardiovascular outcomes trial before the submission of zilebesiran for regulatory approval. The cost of the development program will be shared 40% by Alnylam and 60% by Roche. RHHBY has the option to lead development for additional indications in the future.
Alnylam previously reported encouraging results from the phase I study of zilebesiran compared with placebo. In the study, patients treated with ≥200 mg single doses of zilebesiran experienced dose-dependent reductions in serum angiotensinogen. The treated patients achieved tonic blood pressure control with consistent and durable blood pressure reduction throughout a 24-hour period for six months after single doses of zilebesiran. The safety profile of the candidate was also acceptable for continuing development.
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). Alnylam believes that zilebesiran has the potential to be a best-in-disease treatment providing transformational benefit, especially to patients with hypertension at high cardiovascular risk.
Zilebesiran can also have potential effectiveness in additional cardiovascular indications with high unmet medical need. To date, the safety and efficacy of zilebesiran have not been established or evaluated by any regulatory body.
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 sports a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks in the same industry are ADC Therapeutics (ADCT - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank 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 63%.
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 Acadia Pharmaceuticals’ 2023 loss per share has narrowed from 58 cents to 31 cents. The estimate for Acadia Pharmaceuticals’ 2024 earnings per share is pegged at 47 cents. Year to date, shares of ACAD have rallied 93.5%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average negative earnings surprise of 2.75%.