Friday saw a spike in Alnylam’s shares after the pharmaceutical company received a second FDA clearance for Amvuttra.
Amvuttra was formerly authorised to treat transthyretin amyloid polyneuropathy, a rare condition where aberrant protein accumulates on the nerves and damages the entire body. The FDA has now approved it for use in individuals with cardiomyopathy, which is a far larger market.
In 2025, these three factors will influence medical stocks.
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Alnylam Pharmaceuticals (ALNY) will compete with BridgeBio Pharma’s (BBIO) new Attruby and Pfizer’s (PFE) Vyndaqel. However, Amvuttra is administered as a shot every six months, whilst Vyndaqel and Attruby are taken as daily tablets.According to a research by William Blair analyst Myles Minter, “We expect strong uptake of Amvuttra in ATTR-CM due to its impressive efficacy and safety profile, along with its differentiated treatment regimen of subcutaneous (under-the-skin dosing).”
The shares of Alnylam surged 11.8% to 283.34. According to MarketSurge, shares are bouncing off their 50-day line and are moving towards a buy target around 304.39 following a consolidation.
The First Cardiomyopathy Silencer
Amvuttra entered the ATTR cardiomyopathy market first in its class. The way that Attruby and Vyndaqel function is by stabilising the aberrant amyloid protein. Instead, Amvuttra functions by inhibiting the amyloid-producing gene.Although they had differing opinions about the pricing, analysts generally anticipated Amvuttra’s approval. Alnylam stated that it will continue to charge $477,000 year for the introduction of Amvuttra for cardiomyopathy. According to a study by Needham analyst Joseph Stringer, that is almost double the $268,000 and $245,000 yearly price tags for Vyndaqel and Attruby, respectively.
According to him, Alnylam intends to gradually lower Amvuttra’s net price “as patient uptake increases in the relatively larger ATTR-CM indication (compared to ATTR-PN).” The business restated its demand that Amvuttra generate between $1.6 billion and $1.725 billion in sales this year.
Stringer maintained his buy recommendation and price objective of 320 for Alnylam shares.Vyndaqel Launches Continue to Be Outstanding
The market is sufficiently large for all three competitors, according to Stringer.
Last year, Vyndaqel, a product of Pfizer, made $5.5 billion in sales but barely held 20% of the market. Following a patent cliff, researchers predict that Vyndaqel will generate $1.9 billion in sales in 2030, followed by Attruby with $1.7 billion and Amvuttra with $5.1 billion.
Additionally, Amvuttra seems to be beneficial for younger and healthier cardiomyopathy patients, and detection rates are increasing, according to William Blair’s Minter. Alnylam stock is rated as an outperform by him.
It “positions Amvuttra well for first-line usage in the milder and younger disease population that is reflective of the current disease population,” he stated.However, Mani Foroohar, an analyst at Leerink Partners, believes that Alnylam may face “significant” challenges because of its enormous price advantage over Vyndaqel and Attruby.
“While management prudently managed expectations — reiterating that ATTR-CM launch will be a 2H25 story — elevated long-term Street projections for market share and crowded long positioning in ALNY skew risk to the downside for the next 12-18 months,” according to the research.
His price objective for Alnylam stock is 206, and he has a market perform rating.