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Amgen shares fall 10% as rival's Lp(a) drug failure raises doubts about olpasiran

A rival heart-drug failure knocked about 10 percent off Amgen's stock, spotlighting how much of the company's growth now rests on experimental drugs that are not yet approved.

By the Semaglutides news desk·
Amgen shares fall 10% as rival's Lp(a) drug failure raises doubts about olpasiran
Image: seekingalpha.com

Amgen shares fell more than 10 percent in early trading after Novartis reported that pelacarsen, its drug for lowering lipoprotein(a), missed the primary endpoint of a Phase 3 cardiovascular outcomes study [1]. Investors read the failure across to Amgen's own Lp(a)-lowering candidate, olpasiran; the stock traded around $405 with a market value of about $213 billion at the time of the drop [1].

Both drugs are designed to lower Lp(a) [1]. The concern raised by pelacarsen's result is that lowering Lp(a) may not reduce cardiovascular risk, which undermines a key part of Amgen's pipeline thesis [1]. In a Seeking Alpha analysis, Edmund Ingham downgraded Amgen to Hold, citing increased uncertainty about olpasiran's commercial viability and the urgent need for new pipeline successes to sustain growth [1].

The financial backdrop sharpens the stakes. Amgen has roughly $13 billion in revenue exposed to patent expirations, and analysts have framed olpasiran and MariTide, the company's experimental obesity drug, as the two programs that have to deliver to offset those declines [1]. The selloff shows how much of Amgen's growth case now rests on those programs [1].

Amgen is making its obesity bet in a market that is already large and still growing. Obesity drug sales reached $66 billion last year and could climb to between $105 billion and $200 billion by 2027 and beyond, according to IQVIA [2]. Eli Lilly leads with its injectable tirzepatide products Mounjaro and Zepbound, while Novo Nordisk holds the early lead in oral obesity drugs [2].

Competition keeps expanding. Lilly's oral obesity pill Foundayo (orforglipron) is approved, and regulatory reviews for it are ongoing in more than 40 markets [2]. Novo's Wegovy pill held about 90 percent of weekly oral prescriptions as of July, roughly 1.5 million people [2]. A temporary Medicare program that began in July, the GLP-1 Bridge program, could expand coverage by an estimated 35 percent and reach around 20 million potential patients, according to the investment bank William Blair [2].

Why it matters for patients

Olpasiran and MariTide are pipeline programs, not marketed medicines [1]. Pelacarsen's failure does not establish how olpasiran will perform, and it is not yet known when or whether olpasiran will produce cardiovascular outcomes data of its own [1]. The result raises doubt about an approach — lowering Lp(a) to cut cardiovascular risk — that had been a central bet in Amgen's pipeline [1].

The wider obesity market is a different story. Sales are projected to keep growing, and analysts expect room for several competing drugs beyond the two current leaders [2]. A temporary Medicare pathway that started in July could widen coverage for obesity medications for some patients [2]. Nothing about the Amgen selloff changes which GLP-1 drugs are approved or covered today.

What happens next

No date has been reported for cardiovascular outcomes results for olpasiran. Rival obesity programs have nearer-term milestones that analysts are watching: Roche is expected to give updates at a Pharma Day on Sept. 28, and AstraZeneca is expected to present data on its amylin candidate AZD6234 at the European Association for the Study of Diabetes meeting from Sept. 28 to Oct. 2 [2]. A regulatory decision on Novo's CagriSema, a combination of cagrilintide and semaglutide, is expected in the fourth quarter [2].

Sources

  1. https://seekingalpha.com/article/4943958-amgen-why-rivals-cholesterol-drug-fail-is-bad-news-for-pharma-rating-downgrade
  2. https://www.biospace.com/drug-development/myriad-catalysts-on-deck-for-obesitys-brightest-stars-as-market-continues-to-accelerate

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