Key Takeaways
- Alnylam shares fell 19% after it expanded its nucresiran heart trial for the second time this year, despite 52% growth in product revenue.
- Sizing the trial for fewer cardiovascular events than planned raises doubts about nucresiran’s benefit.
- Ionis’s eplontersen already missed its main goal in a similar trial, while rival drugs from Pfizer and BridgeBio keep growing.
- Analysts expect revenue to keep climbing through 2028 on AMVUTTRA, so the drop looks bigger than the news.
Alnylam Pharmaceuticals (ALNY) just reported its biggest quarter yet, and the stock is down 19% today anyway. The reason: it’s enlarging the Phase 3 trial of nucresiran, its next-generation heart drug, for the second time this year.
Its AMVUTTRA competes for ATTR-CM patients with tafamidis from Pfizer (PFE) and Attruby from BridgeBio Pharma (BBIO). And Ionis Pharmaceuticals (IONS) has already watched its own drug miss in a heart outcomes trial.
500 more patients, again
Third-quarter product revenue rose 52% to $1.29 billion, with AMVUTTRA up 65%.
In April, Alnylam grew the TRITON-CM trial from 1,250 to about 1,750 patients. Today it went to about 2,250, saying it stays adequately powered even under conservative estimates of cardiovascular events.
On the third-quarter call, CEO Yvonne Greenstreet said Alnylam has “a high level of conviction” in a positive result.
My read: Alnylam is bracing for fewer events than planned, which makes a benefit harder to prove. It still expects to launch nucresiran by 2030.
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A little breathing room for the rivals
Ionis has been here. Its partnered drug eplontersen missed the main goal of its CARDIO-TTRansform heart study, Ionis said in July. Ionis has little riding on the heart indication now: eplontersen’s WAINUA royalties were $16 million of its $268 million of second-quarter revenue.
Pfizer and BridgeBio stand to gain if nucresiran’s data come in weaker. Pfizer’s tafamidis family grew 8% operationally in the second quarter, and Attruby brought BridgeBio $222.4 million of US net sales. Pfizer’s report next week will show whether tafamidis keeps growing against both.
The drop looks bigger than the news
Wall Street expects Alnylam’s revenue to keep climbing fast through 2028.
Those years ride on AMVUTTRA, and nothing in today’s update should move them much. The stock traded at about 21x forward earnings at the last close, and even lower now.
My take: the market is pricing in a lot of doubt about a trial that’s years from reading out. That looks like an overreaction.
Of course, nucresiran is meant to carry the franchise beyond AMVUTTRA, so a weak readout would hurt. Next up: two-year HELIOS-B data at the American Heart Association’s meeting, Nov. 6-9.
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