Amgen Just Killed Two Programs in One Week. Should Investors Worry?
Amgen axed two clinical programs in the same week after Phase 2 disappointments, one in lung cancer and one in Sjögren's disease. The dual failures spotlight pharma's toughest development stage and raise questions about pipeline depth at a $35 billion company.
The Double Punch
Imagine training for two marathons at once, only to pull a hamstring in both legs on the same day. That's roughly what happened to Amgen this week.
The pharma giant faced setbacks in two clinical programs after Phase 2 disappointments: one in cancer, one in Sjögren's disease (an autoimmune condition that attacks moisture-producing glands, leaving patients with painfully dry eyes and mouths). Both programs hit the wall at the same development stage, and both got axed in quick succession.
The cancer program involved AMG 193, a first-in-class drug targeting a specific genetic vulnerability in non-small cell lung cancer, where Amgen ended its combination collaboration with Ideaya (AMG 193 + IDE397), though AMG 193 monotherapy trials remain active. The Sjögren's candidate, AMG 329, was a monoclonal antibody designed to tamp down inflammatory pathways. Neither combination nor AMG 329 delivered what Amgen needed to see.
For a company with $36.8 billion in total 2025 revenue, losing a combination program and a mid-stage candidate isn't an existential crisis. But it raises an uncomfortable question: is Amgen's pipeline as deep as investors think?
What AMG 193 Was Supposed to Do
AMG 193 had a clever premise. About 15% of non-small cell lung cancers carry a deletion in a gene called MTAP. When that gene is missing, cancer cells become dependent on a specific enzyme called PRMT5 to survive. AMG 193 was designed to exploit that dependency, essentially kicking away the crutch that MTAP-deleted tumors lean on.
Think of it like a thief who can only escape through one door. AMG 193 was supposed to lock that door.
The drug was a "MTA-cooperative PRMT5 inhibitor," meaning it worked alongside a naturally occurring molecule to shut down the enzyme. On paper, the science was elegant. In patients, the combination results apparently weren't compelling enough. Amgen ended the combination collaboration with Ideaya following a portfolio review and what it called "emerging clinical data," though AMG 193 monotherapy trials continue.
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No detailed efficacy numbers have been disclosed publicly.
AMG 329: When "Futility" Says It All
The Sjögren's story is more straightforward, and arguably more painful. AMG 329, a fully human antibody targeting FLT3 ligand (a protein involved in immune cell development), met pre-defined criteria for futility in its Phase 2 trial.
In clinical trial language, "futility" is the polite way of saying: even if we kept enrolling patients, this drug is statistically unlikely to work. It's like being down 40 points at halftime and your coach calling the game. The math just doesn't support continuing.
Futility stopping rules exist to protect patients from taking drugs that won't help them. They're responsible science. But they're also brutal for the companies that trigger them.
Amgen's Immunology Backup Plan
The good news for Amgen: AMG 329 wasn't their only bet on Sjögren's disease. Not even close.
The company is running two Phase 3 studies of dazodalibep, a different drug with a different mechanism, in Sjögren's patients. One trial targets patients with moderate-to-severe systemic disease activity. The other focuses on patients with high symptom burden but lower systemic involvement. Both are expected to wrap up in the second half of 2026.
Dazodalibep's primary goal is measuring improvement in patient-reported symptoms, with secondary endpoints covering salivary flow (a big deal for people whose mouths feel like sandpaper) and systemic disease markers.
So Amgen hasn't abandoned Sjögren's. They've just lost one of their two horses in the race. Whether dazodalibep crosses the finish line remains an open question.
A Crowded Race With No Winner Yet
What makes the Sjögren's setback particularly notable is the broader competitive landscape. There are currently zero approved disease-modifying therapies for Sjögren's syndrome. Every treatment on the market is purely palliative: eye drops, saliva substitutes, symptom management. Nothing addresses the underlying autoimmune attack.
That unmet need has attracted a crowd. Over 22 pipeline therapies from more than 20 companies are now in development. Novartis is advancing ianalumab. Bristol-Myers Squibb, Argenx, Astellas, and AbbVie all have programs in various stages. The first company to deliver a true disease-modifying drug will own an enormous market.
Amgen's loss of AMG 329 narrows their shot at being first across the line, though dazodalibep's Phase 3 timeline keeps them in contention.
The Bigger Picture: Phase 2 Is Where Dreams Go to Die
If there's one thing these dual setbacks illustrate, it's a truth that biotech investors often forget: Phase 2 is the graveyard stage of drug development.
Industry-wide, approximately 60% of drugs that enter Phase 2 never make it to Phase 3. In oncology specifically, the odds are even worse. Only about 5-11% of Phase 2 oncology drugs eventually reach FDA approval. The reasons are almost always the same: the drug works beautifully in early testing, then fails to produce meaningful benefits in larger, more diverse patient populations.
Phase 1 tells you if a drug is safe. Phase 2 tells you if it actually works. And "actually works" is a brutally high bar.
Amgen isn't unique in facing this attrition. Pfizer trimmed its pipeline from 271 to 257 assets recently. Strategic Phase 2 terminations across the industry spiked 42% year-over-year in 2022, and that discipline has continued. The entire biopharma R&D pipeline actually shrank 3.9% to about 22,940 drugs entering 2026, the first decline in 30 years.
Companies are getting more ruthless about killing programs early rather than throwing good money after bad. That's arguably healthy, even when it stings.
IMDELLTRA (tarlatamab), their bispecific T-cell engager for small cell lung cancer, received full FDA approval in November 2025 after Phase 3 data showed a 40% reduction in death risk compared to standard treatment. Median overall survival hit 13.6 months versus 8.3 months for the control group. Sales reached $627 million in 2025. That's a genuine win.
Their biosimilars business generated $3 billion in 2025 sales, up 37% year-over-year, with late-stage candidates targeting Opdivo, Keytruda, and Ocrevus. UPLIZNA, acquired through the Horizon deal, grew 73% to $655 million on new approvals for IgG4-related disease and myasthenia gravis.
Amgen's innovative oncology sales rose 11% to $8.7 billion last year, with total oncology sales reaching approximately $10 billion. The company's CEO has talked about "double-digit growth" heading into 2026.
So no, two Phase 2 setbacks don't sink the ship. But they do reveal the gaps.
The Strategic Calculation
Amgen is spending $2.6 billion on capital expenditure in 2026, up from $1.9 billion in 2025. They're investing heavily in manufacturing and pipeline execution. The question is whether that money is flowing toward enough shots on goal.
In immunology specifically, Amgen faces a lineup of competitors with deeper portfolios. AbbVie is expanding Skyrizi and Rinvoq across multiple new indications while exploring in vivo CAR-T therapy for autoimmune diseases. Novartis and Bristol-Myers Squibb are pushing hard in overlapping spaces.
Amgen's differentiation strategy relies on their BiTE (bispecific T-cell engager) platform, their biosimilar revenue engine, and the Horizon acquisition assets. It's a hybrid model: part innovation, part fast-follower, part volume play. Losing pipeline candidates doesn't break that model, but it does make the remaining programs carry heavier expectations.
What This Means for You
If you're an Amgen investor, these setbacks are noise, not signal. The company's revenue engine is intact, and the programs that matter most (IMDELLTRA expansion, dazodalibep, MariTide in obesity) are still running.
If you're watching the Sjögren's space, this is a reminder that the disease remains stubbornly difficult to treat. The first approved disease-modifying therapy will be a landmark moment. We're still waiting.
And if you're just someone who follows biotech, the lesson is evergreen: even companies with nearly $37 billion in revenue and world-class R&D operations fail at Phase 2. A lot. The difference between good pharma companies and great ones isn't avoiding failure; it's knowing when to walk away and where to redeploy the resources.
Amgen walked away twice this week. Now we get to watch where they point those resources next.
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