Piper Sandler has reaffirmed its confidence in Alnylam Pharmaceuticals, maintaining an Overweight rating and a price target of $296.00 on the company’s stock.
Alnylam has recently submitted a supplemental New Drug Application (sNDA) for AMVUTTRA to treat ATTR-CM, a cardiac condition, based on encouraging results from the Phase III HELIOS-B study.
The HELIOS-B trial data showed that AMVUTTRA led to a significant reduction in mortality and cardiovascular events among patients. Specifically, there was a 28% decrease in all-cause mortality and recurrent cardiovascular events, with a 31% reduction in all-cause mortality and a 27% decrease in recurrent cardiovascular events observed over a 36-month period.
Alnylam plans to expedite the review process of AMVUTTRA by utilizing a Priority Review Voucher (PRV), anticipating FDA approval in the first half of 2025. The company is also preparing to release more data from its Phase I ALN-TTRsc04 study within this year and will detail its Phase III development plans in 2025.
According to Piper Sandler, the positive outcomes from the HELIOS-B study, combined with Alnylam’s existing commercial infrastructure and market presence in treating hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN), set the stage for a successful launch of AMVUTTRA in the treatment of ATTR-CM. Projections suggest that AMVUTTRA’s revenue could more than double from $923 million in 2024 to $2.4 billion by 2026.
In other recent news, Alnylam Pharmaceuticals has been making headway in the biopharmaceutical sector, with an emphasis on its earnings and revenue results. The company’s Q2 earnings report surpassed expectations in both revenue and profit, leading to an updated 2024 revenue guidance of between $1.575 billion and $1.65 billion. This success is attributed to the growth of its TTR franchise and a milestone payment from a licensing agreement with Regeneron (NASDAQ:).
Alnylam has submitted a supplemental New Drug Application (sNDA) to the FDA for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy (ATTR-CM), following positive results from the HELIOS-B Phase 3 study.
Analyst firms including Goldman Sachs, TD Cowen, BofA Securities, Piper Sandler, and Canaccord Genuity have maintained positive ratings on Alnylam, reflecting these recent developments.
The company’s commercial strategy for the launch of Amvuttra in treating ATTR-CM also received positive feedback from BofA Securities. It plans to establish Amvuttra as the first-line treatment of choice for this condition, leveraging the encouraging HELIOS-B trial data and a more convenient dosing regimen. In collaboration with BridgeBio Pharma (NASDAQ:), Alnylam presented a new post hoc analysis of recurrent all-cause mortality and cardiovascular-related hospitalization events.
InvestingPro Insights
Alnylam Pharmaceuticals’ strong market position and promising drug pipeline are reflected in its recent financial performance and market valuation. According to InvestingPro data, the company’s revenue growth has been impressive, with a 107% increase in quarterly revenue as of Q2 2024. This aligns with the positive outlook for AMVUTTRA’s potential in treating ATTR-CM.
InvestingPro Tips highlight that Alnylam boasts impressive gross profit margins, which stood at 87% for the last twelve months as of Q2 2024. This strong profitability at the gross level suggests efficient production and pricing power, which could be crucial as the company expands its product offerings.
Despite the positive revenue growth and gross margins, it’s worth noting that analysts do not anticipate the company to be profitable this year, according to another InvestingPro Tip. This is not uncommon for biotech companies investing heavily in research and development, especially with promising drug candidates in the pipeline.
For investors seeking a more comprehensive analysis, InvestingPro offers 10 additional tips for Alnylam Pharmaceuticals, providing a deeper understanding of the company’s financial health and market position.
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