Novartis Pelacarsen Failure Jolts Lp(a) Drug Race — SkimNews
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- Novartis's pelacarsen, developed jointly with Ionis Pharmaceuticals, failed to significantly improve cardiovascular outcomes in a late-stage trial of more than 8,000 patients already on optimized care, despite reducing Lp(a) cholesterol
- Novartis stock fell 3% on Monday after the Friday after-bell announcement, while Amgen dropped about 5%, Ionis plunged 10%, and NewAmsterdam Pharma fell 12% in extended Friday trading
- Citi analysts called the result 'the first dedicated outcomes failure' that 'lowers confidence across the class,' while cautioning 'The Lp(a) hypothesis is weakened, but not disproven' pending full data
- Analysts had modeled peak annual sales of $4 billion to $5 billion for pelacarsen if it succeeded — a potential boost Novartis needed as CEO Vas Narasimhan confronts what he called 'the steepest patent cliff in its history,' with Entresto already losing key patent exclusivities
- Amgen's olpasiran faces the clearest read-through from the failure, while Lilly's lepodisiran is being tested on a broader population that includes patients without established cardiovascular disease, potentially limiting direct read-through, Citi noted
- Jefferies analysts flagged that improving standards of care are reducing cardiovascular events, potentially making it harder and more costly for experimental drugs to prove added benefit in future trials
- Lp(a) — discovered in 1963, affecting roughly one in five people worldwide, and largely unresponsive to diet or exercise — currently has no approved targeted treatment, and full pelacarsen results will be presented at an upcoming medical congress
Why it matters: Lp(a) affects roughly one in five people worldwide with no approved targeted treatment, making this a potential multibillion-dollar market. As the first dedicated outcomes test in the space, pelacarsen's failure now forces Amgen's olpasiran most directly to prove that deeper Lp(a) lowering can deliver the ~15% major adverse cardiovascular event reduction Citi says is required for class credibility — a higher bar than the moderate benefit many investors had already priced in.
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