Key Highlights

  • Amgen fell about 10% on September 8 after Novartis said on September 4 that pelacarsen's Lp(a)HORIZON outcomes trial missed its primary endpoint.
  • Shares rose 4.3% to $410.24 on September 22, the day Amgen reported positive Phase 3 OASIZ 301 results for dazodalibep.
  • On September 14 the FDA cut Imdelltra's monitoring time for the first two doses from 22-24 hours to 6-8 hours; olpasiran's own outcomes data are still pending.
  • Q2 2026 Revenue rose 10% year over year to $10.1 billion, with non-GAAP EPS of $6.29 and free Cash Flow of $3.5 billion.

Amgen (NASDAQ:AMGN) shares have recovered most of the ground they lost in early September. That selloff followed a failed cardiovascular outcomes trial of Novartis (NYSE:NVS)' Lp(a)-lowering drug pelacarsen, which raised doubts about Amgen's own Lp(a) candidate, olpasiran. On September 22 the stock rose 4.3% to close at $410.24, well above the roughly $394 level it hit at midday on September 8, when it fell about 10%.

Several things drove the rebound. Some Wall Street analysts argued that olpasiran has a different profile from the program that failed, which eased fears that the whole Lp(a) drug class had been undermined. Amgen also delivered two pieces of good news in the same period. On September 14, the FDA approved a label update that sharply cuts post-infusion monitoring time for its lung cancer drug Imdelltra. On September 22, the company reported a positive Phase 3 readout for dazodalibep in Sjögren's disease on the day of the bounce.

Market commentary has not attributed the recovery to any one cause, and olpasiran's own outcomes data are still pending. The fundamental question raised by the Novartis trial remains open.

How the Novartis Trial Rattled the Lp(a) Class

On September 4, Novartis announced that its Phase 3 Lp(a)HORIZON trial of pelacarsen, which enrolled 8,323 patients with elevated Lp(a) and established cardiovascular disease, did not meet its primary endpoint. That endpoint was a composite of cardiovascular death, non-fatal heart attack, non-fatal stroke and urgent coronary revascularization requiring hospitalization. "Although lower Lp(a) levels were observed with pelacarsen, the findings did not demonstrate that this translated into reduced cardiovascular risk in the overall study population," Novartis Chief Medical Officer Shreeram Aradhye said in the release. Novartis said full results would be presented at an upcoming medical congress.

When US markets reopened after the Labor Day weekend, Amgen took the hit. The stock fell about 10% on September 8, with olpasiran, which is in the Phase 3 OCEAN(a)-Outcomes trial, seen as the pipeline asset most exposed to the class re-rating. Citi analysts said the Lp(a) hypothesis "has been weakened," adding that more data were needed to tell whether the failure came from the drug's mechanism, the trial design or the underlying biology.

Why Olpasiran May Be Viewed Differently

Pelacarsen is an antisense oligonucleotide, while olpasiran is a small interfering RNA, a different way of silencing production of the protein that forms Lp(a). Some analysts have argued this distinction, along with differences in dosing and trial design, could produce different outcomes. That remains a thesis, not a demonstrated result. Only the OCEAN(a)-Outcomes data can settle whether olpasiran lowers heart attack and stroke risk, and Amgen has not said when that readout will come.

Imdelltra and Dazodalibep Add Support

The Imdelltra label update cuts recommended monitoring after each of the first two doses from 22 to 24 hours down to 6 to 8 hours for patients with extensive-stage small cell lung cancer whose disease progressed on or after platinum chemotherapy. Amgen said roughly 80% to 85% of US cancer patients are treated in community settings, where long monitoring periods had been a practical barrier. "Reducing monitoring to 6-8 hours for the initial doses may help address practical barriers," Executive Vice President of Research and Development Jay Bradner said.

In the September 22 release, Amgen said the OASIZ 301 study of dazodalibep, a CD40L antagonist, met its primary endpoint in about 621 adults with moderate-to-severe systemic Sjögren's disease. The drug showed a statistically significant improvement in disease activity at Week 48, with benefits seen as early as Week 4. A second study, OASIZ 303, is expected to complete in the fourth quarter of 2026. Citi described dazodalibep's competitive profile as an "open question."

Second-Quarter Results and 2026 Guidance

Amgen reported second-quarter revenue of $10.1 billion on August 4, up 10% year over year, with product sales of $9.537 billion. GAAP EPS was $4.37 and non-GAAP EPS was $6.29, and free cash flow was $3.5 billion. Repatha sales rose 37% to $953 million and Evenity rose 38% to $714 million. Tezspire grew 42% to $486 million, Uplizna 90% to $335 million, and Imdelltra 115% to $288 million. Biosimilar competition cut Prolia sales 32% to $759 million and Xgeva 34% to $352 million. Amgen guided 2026 revenue to $38.2 billion to $39.4 billion and non-GAAP EPS to $22.30 to $23.50.

Competitive Landscape in Cardiometabolic Drugs

Lp(a) has been one of cardiology's most closely watched targets, with several large drugmakers developing therapies. Amgen already has a strong cardiovascular Franchise in Repatha, which lowers LDL cholesterol. It is also developing MariTide for obesity, a field dominated by Eli Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO). The pelacarsen result means rival Lp(a) programs will face more scrutiny until outcomes data arrive.

Risks Investors Are Weighing

The main risk is a negative or modest olpasiran outcome, which would remove a potential large cardiovascular franchise. Biosimilar erosion of Prolia and Xgeva will continue to weigh on sales. Obesity is an expensive and competitive race. Analyst sentiment is mixed, with a consensus Hold rating from 34 analysts and an average price target of $388.03, below the September 22 close; HSBC downgraded the stock to Hold from Buy with a $425 target earlier this month. Drug pricing policy in the United States is another ongoing uncertainty.

Amgen's Next Catalysts on the Calendar

Upcoming catalysts include Novartis' full presentation of the Lp(a)HORIZON data, which could clarify why pelacarsen failed and how much it tells investors about olpasiran. Amgen's next Quarterly Report is expected around November 3, 2026, though the company had not confirmed a date. Investors will also watch the OASIZ 303 completion expected in the fourth quarter, detailed dazodalibep data at a future medical meeting, Imdelltra uptake in community clinics and MariTide Phase 3 progress. Any Amgen update on OCEAN(a)-Outcomes timing is likely to move the stock.