Alnylam jumps as expanded US approval for heart disease drug fuels growth prospects

Audio By Carbonatix

By Sriparna Roy

(Reuters) -Alnylam Pharmaceuticals’ shares rose more than 10% on Friday after the drugmaker secured U.S. approval for its heart disease drug, setting the stage for the 23-year-old biotech’s next phase of growth.

Amvuttra, a quarterly injection, was cleared to treat ATTR-CM, a condition where faulty transthyretin proteins accumulate in the heart, potentially causing the organ to fail.

“Close to the best case scenario,” RBC analyst Luca Issi said, given the upcoming launch in a $6-billion market with 90% of patients untreated and profitability expected this year.

The approval, nearly three years after Amvuttra was first cleared for nerve damage related to the disease, makes it the first drug to treat both forms of ATTR-CM. The drug works by silencing the production of the disease-causing protein.

These factors could help set it apart in a competitive market that includes Pfizer’s blockbuster treatment Vyndaqel and BridgeBio Attruby.

“We think Amvuttra’s differentiated mechanism of action, convenient dosing, and strong clinical dataset position it to become the new standard of care in ATTR-CM,” said BofA analyst Tazeen Ahmad.

The prescribing information for all three drugs highlights their ability to reduce hospitalizations or death from heart complications. Amvuttra’s label also includes a reduction in urgent heart failure visits.

The label suggests Amvuttra could become the preferred treatment for milder, younger patients, who make up a large portion of the population, said William Blair analyst Myles Minter.

Analysts expect Amvuttra to bring in revenue of $4.47 billion by 2030, according to LSEG data.

The company expects the ATTR-CM indication to meaningfully contribute to revenue in the second half of 2025.

Alnylam maintained the list price of $119,351 per prefilled syringe for the drug. It plans to decrease Amvuttra’s net pricing over time as more patients start receiving the treatment.

The unchanged price indicates the company’s “high confidence”, said BMO Capital Markets analyst Kostas Biliouris.

However, at least three analysts said this was at a premium to rivals and could sway certain doctors and insurers toward other treatments.

(Reporting by Sriparna Roy in Bengaluru; Editing by Sriraj Kalluvila)