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On Friday, Stifel analysts upheld their Buy rating and $300.00 price target for Alnylam Pharmaceuticals (NASDAQ:ALNY), following the U.S. Food and Drug Administration’s (FDA) approval of Amvuttra. The analysts expressed continued confidence in the stock, emphasizing the significance of the drug’s label and pricing strategy post-approval. The company’s stock has delivered an impressive 73% return over the past year, and according to InvestingPro data, analysts’ price targets range from $195 to $500, reflecting diverse market expectations.
The FDA’s nod for Amvuttra was closely watched, with particular attention on whether the label would explicitly mention cardiovascular mortality benefits and the pricing strategy for the treatment of transthyretin-mediated cardiomyopathy (TTR-CM). Alnylam decided to maintain its premium pricing for Amvuttra at launch, a move that Stifel analysts anticipated and supported due to the robust clinical data backing the drug. This pricing strategy appears well-supported by the company’s strong financial position, with InvestingPro data showing an impressive 85.6% gross profit margin and 23% revenue growth over the last twelve months.
The analysts highlighted that the pricing strategy is sensible, especially considering that the majority of the TTR-CM market consists of Medicare patients. Unlike competing drugs tafamidis and acoramidis, which are covered under Medicare Part D, Amvuttra will be reimbursed through Medicare Part B, involving a different payer channel.
Furthermore, the inclusion of HELIOS-B clinical data on mortality within the drug’s label was noted as a positive outcome. Stifel analysts had previously believed that the market might have been overly focused on the nuances of the labeling. However, they acknowledged that the mortality data would aid in differentiating Amvuttra’s marketing message from its competitors.
Alnylam Pharmaceuticals’ ability to secure FDA approval for Amvuttra with a label that includes mortality data and to launch the drug without a price cut reflects a strategic approach that aligns with the strength of the clinical evidence and the existing reimbursement landscape for Medicare patients.
In other recent news, Alnylam Pharmaceuticals has achieved a significant milestone with the FDA approval of its drug Amvuttra for treating transthyretin amyloid cardiomyopathy (ATTR-CM). This approval is notable as Amvuttra becomes the first and only FDA-approved therapy for both the cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis. The drug’s approval followed positive results from the HELIOS-B Phase 3 clinical trial, which showed a 28% reduction in all-cause mortality and recurrent cardiovascular events. Analysts from Canaccord Genuity responded by raising their price target for Alnylam to $390, maintaining a Buy rating, while Scotiabank (TSX:BNS) increased their target to $338, keeping a Sector Outperform rating. The pricing strategy for Amvuttra, set at approximately $477,000 annually, includes volume-based rebates to reduce the net cost over time. Cantor Fitzgerald reaffirmed its Neutral rating and $250 price target, noting the unique benefits of Amvuttra’s label, which includes a reduction in urgent heart failure visits. The company has also emphasized its commitment to patient access, with most patients expected to incur no out-of-pocket costs for Amvuttra. These developments position Alnylam Pharmaceuticals for potential growth in the treatment landscape for ATTR-CM.
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