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ALNY Down Despite Positive Data From Heart Disease Drug Study
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Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) were down 8.5% on Aug. 30, after the company announced detailed data from the phase III HELIOS-B, which evaluated its investigational RNAi therapeutic, Amvuttra (vutrisiran) for an expanded indication.
The HELIOS-B study is seeking to expand the label of Amvuttra for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
Per the company, the HELIOS-B study met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular events in the overall population as well as the monotherapy population.
However, as a component of the primary endpoint, treatment with vutrisiran led to a 30% reduction in mortality in the monotherapy population in the double-blind period. Per management, this reduction was non-significant.
This might have hurt investors’ sentiments and resulted in the stock going down.
ALNY Stock Outperforming Industry
Shares of Alnylam have gained 37.3% so far this year compared with the industry’s growth of 0.6%.
Image Source: Zacks Investment Research
Please note that vutrisiran is already approved in the United States for the treatment of adult patients with polyneuropathy of hereditary ATTR amyloidosis. This is also approved in the European Union for the same indication in adult patients with stage 1 or stage 2 polyneuropathy. Vutrisiran is marketed under the trade name Amvuttra in the United States and Europe.
In June 2024, Alnylam reported encouraging data from the phase III HELIOS-B study evaluating vutrisiran for the treatment of patients with ATTR amyloidosis with cardiomyopathy. Shares of the company soared on this news.
The phase III HELIOS-B study enrolled 655 adult patients with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy who were divided equally to receive vutrisiran 25mg or placebo subcutaneously once every three months for up to 36 months.
Alnylam is gearing up to proceed with global regulatory submissions, including filing a supplemental new drug application for vutrisiran with the FDA using a Priority Review Voucher later in 2024.
Amvuttra, a Key Revenue Driver for ALNY
Amvuttra is currently the top contributor to Alnylam’s top line. This drug generated sales worth $425.4 million in the first half of 2024, increasing 82% year over year on a reported basis. The encouraging uptake of the drug is driven by new patients starting treatment as well as patients switching from ALNY’s Onpattro(patisiran).
Onpattro is also approved in the United States and European Union to treat ATTR amyloidosis in adults.
If approved forthe new indication, Alnylam believes that vutrisiran has the potential to become the new standard of care for the treatment of ATTR amyloidosis with cardiomyopathy. This is likely to boost sales further and will expand the eligible patient population for the drug in future quarters.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 26.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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ALNY Down Despite Positive Data From Heart Disease Drug Study
Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) were down 8.5% on Aug. 30, after the company announced detailed data from the phase III HELIOS-B, which evaluated its investigational RNAi therapeutic, Amvuttra (vutrisiran) for an expanded indication.
The HELIOS-B study is seeking to expand the label of Amvuttra for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
Per the company, the HELIOS-B study met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular events in the overall population as well as the monotherapy population.
However, as a component of the primary endpoint, treatment with vutrisiran led to a 30% reduction in mortality in the monotherapy population in the double-blind period. Per management, this reduction was non-significant.
This might have hurt investors’ sentiments and resulted in the stock going down.
ALNY Stock Outperforming Industry
Shares of Alnylam have gained 37.3% so far this year compared with the industry’s growth of 0.6%.
Image Source: Zacks Investment Research
Please note that vutrisiran is already approved in the United States for the treatment of adult patients with polyneuropathy of hereditary ATTR amyloidosis. This is also approved in the European Union for the same indication in adult patients with stage 1 or stage 2 polyneuropathy. Vutrisiran is marketed under the trade name Amvuttra in the United States and Europe.
In June 2024, Alnylam reported encouraging data from the phase III HELIOS-B study evaluating vutrisiran for the treatment of patients with ATTR amyloidosis with cardiomyopathy. Shares of the company soared on this news.
The phase III HELIOS-B study enrolled 655 adult patients with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy who were divided equally to receive vutrisiran 25mg or placebo subcutaneously once every three months for up to 36 months.
Alnylam is gearing up to proceed with global regulatory submissions, including filing a supplemental new drug application for vutrisiran with the FDA using a Priority Review Voucher later in 2024.
Amvuttra, a Key Revenue Driver for ALNY
Amvuttra is currently the top contributor to Alnylam’s top line. This drug generated sales worth $425.4 million in the first half of 2024, increasing 82% year over year on a reported basis. The encouraging uptake of the drug is driven by new patients starting treatment as well as patients switching from ALNY’s Onpattro(patisiran).
Onpattro is also approved in the United States and European Union to treat ATTR amyloidosis in adults.
If approved forthe new indication, Alnylam believes that vutrisiran has the potential to become the new standard of care for the treatment of ATTR amyloidosis with cardiomyopathy. This is likely to boost sales further and will expand the eligible patient population for the drug in future quarters.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 26.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.