Denison Mines announces $250 million convertible notes offering
Friday, Cantor Fitzgerald reaffirmed its Neutral rating and $250.00 price target for Alnylam Pharmaceuticals (NASDAQ:ALNY), a $32.8 billion market cap biotechnology company with a strong financial health score according to InvestingPro, following the FDA’s approval of the company’s drug, Amvuttra, for the treatment of ATTR-CM, a heart condition. The company has demonstrated impressive revenue growth of 23% over the last twelve months, despite operating at a loss. The approval, which came a few days earlier than the anticipated PDUFA date, includes language on the label regarding cardiovascular mortality, which was a point of debate among industry watchers.
The new label for Amvuttra distinguishes itself from competitors by including the reduction of "urgent heart failure visits" as a benefit, a claim not present on the labels of similar drugs such as Attruby and Vyndamax. This specific language positions Amvuttra uniquely in the market and could be a differentiator for Alnylam Pharmaceuticals’ product offering.
Cantor Fitzgerald’s analyst noted that the approval was expected, despite the discussion surrounding the inclusion of mortality language on the label. The exact wording on the label states that Amvuttra is approved for "the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits."
The analyst also remarked on the statistical data related to Amvuttra, pointing out that nothing particularly stood out in the provided statistics or the All-Cause Mortality curves, which were documented up to 33 months. Notably, Alnylam’s stock has delivered a remarkable 73% return over the past year, significantly outperforming the market. For deeper insights into Alnylam’s valuation and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports. This duration of data is not unusual when compared to similar drugs from Pfizer (NYSE:PFE) (covered as Neutral) and BridgeBio Pharma (NASDAQ:BBIO) (covered with an Overweight rating by analyst J. Schimmer).
The FDA’s approval of Amvuttra ahead of the expected date is a significant regulatory milestone for Alnylam Pharmaceuticals. The company’s ability to market the drug with the specific benefits outlined in the label could potentially impact its position in the treatment landscape for ATTR-CM. With analyst price targets ranging from $195 to $500 and expectations of profitability this year, according to InvestingPro data, this approval could be a crucial catalyst for the company’s future performance.
In other recent news, Alnylam Pharmaceuticals announced the FDA approval of AMVUTTRA for treating transthyretin-mediated amyloidosis (ATTR), marking it as the first and only FDA-approved therapy for both cardiomyopathy and polyneuropathy manifestations of the condition. The approval followed positive outcomes from the HELIOS-B Phase 3 clinical trial, which showed a significant reduction in all-cause mortality and recurrent cardiovascular events. Canaccord Genuity analysts responded by raising their price target for Alnylam to $390, maintaining a Buy rating, while Scotiabank (TSX:BNS) increased its target to $338 with a Sector Outperform rating. Alnylam has set the wholesale acquisition cost of AMVUTTRA at approximately $477,000 annually, with plans for volume-based rebates to lower the net price over time.
Additionally, Alnylam co-founder Dr. Phillip A. Sharp (OTC:SHCAY) announced his retirement from the Board of Directors, effective May 2025, though he will continue to serve on the company’s Scientific Advisory Board. H.C. Wainwright reaffirmed its $500 price target and Buy rating, citing confidence in Alnylam’s RNA interference pipeline and the potential for AMVUTTRA to lead in ATTR amyloidosis treatment. The firm also highlighted Alnylam’s expansion into neurology and metabolic diseases, with promising treatments in development for Alzheimer’s Disease and Huntington’s disease. Alnylam’s strategic vision includes the potential for over $20 billion in peak annual revenues, contingent upon regulatory approval of its upcoming therapies.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.