✦ Dazodalibep and Sjögren's DiseaseNarrow moat

Amgen (AMGN) — the future bets

Dazodalibep met its Phase 3 endpoint in a common autoimmune disease with no approved medicine, the kind of market Amgen's older drugs no longer have.

Dazodalibep is Amgen's most promising new result of 2026. On 22 September its Phase 3 OASIZ 301 study, in about 621 adults with moderate-to-severe systemic Sjögren's disease1, met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 482 on the standard disease-activity index. Improvements were observed as early as week 43.

Dazodalibep programmeOASIZ 301n=621; primaryendpoint met,Sept 2026Week 4firstimprovementsobservedOASIZ 303symptomaticpatients; completesQ4 2026OASIZ 304long-termextensionUS patent2034Amgen dazodalibep release, 22 September 2026; Form 10-K FY2025
One positive study, one to come.

The opportunity is the absence of rivals. Amgen's release says there are currently no FDA-approved medicines for Sjögren's disease4, an autoimmune disease that causes dryness, fatigue and pain and can affect organs throughout the body. The release calls it the second most common autoimmune rheumatic disease5.

Dazodalibep is a potential first-in-class CD40L antagonist fusion protein6. The safety profile in the topline report was unremarkable: the most common adverse events were generally mild to moderate, discontinuations were low and balanced, and there was no imbalance in thromboembolic events or opportunistic infections7.

A second Phase 3 study, OASIZ 303, in patients with high symptom burden but low systemic activity, is expected to complete in the fourth quarter of 20268. Its United States patent runs to 20349.

Amgen's head of research described the results as an important step forward for a condition with significant unmet need and no approved systemic treatment options10. Detailed data are to be presented at an upcoming medical meeting11, and the size of the benefit, not just its statistical significance, will decide how widely doctors use it.

Dazodalibep could be Amgen's next wholly owned franchise, one without a partner's share or a crowded class. The next test is OASIZ 303; a positive result in the symptomatic group would roughly double the eligible patients, and a miss would leave a drug for the smaller systemic population only.

Moat trajectory: Widening

Phase 3 OASIZ 301 positive (Sept 2026); OASIZ 303 due Q4 2026.

The number that tests this moat
Reported
Dazodalibep Phase 3 studies read out positive
1 of 2 (OASIZ 301, Sept 2026; OASIZ 303 due Q4 2026)

The pace of the programme; a miss in OASIZ 303 would halve the eligible market.

Source: Amgen dazodalibep Phase 3 release ↗
References
  1. ReportedOn 22 September its Phase 3 OASIZ 301 study, in about 621 adults with moderate-to-severe systemic Sjögren's disease, met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48 on the standard disease-activity index.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  2. ReportedOn 22 September its Phase 3 OASIZ 301 study, in about 621 adults with moderate-to-severe systemic Sjögren's disease, met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48 on the standard disease-activity index.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  3. ReportedImprovements were observed as early as week 4.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  4. ReportedAmgen's release says there are currently no FDA-approved medicines for Sjögren's disease, an autoimmune disease that causes dryness, fatigue and pain and can affect organs throughout the body.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  5. ReportedThe release calls it the second most common autoimmune rheumatic disease.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  6. ReportedDazodalibep is a potential first-in-class CD40L antagonist fusion protein.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  7. ReportedThe safety profile in the topline report was unremarkable: the most common adverse events were generally mild to moderate, discontinuations were low and balanced, and there was no imbalance in thromboembolic events or opportunistic infections.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  8. ReportedA second Phase 3 study, OASIZ 303, in patients with high symptom burden but low systemic activity, is expected to complete in the fourth quarter of 2026.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  9. ReportedIts United States patent runs to 2034.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
  10. ReportedAmgen's head of research described the results as an important step forward for a condition with significant unmet need and no approved systemic treatment options.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
  11. ReportedDetailed data are to be presented at an upcoming medical meeting, and the size of the benefit, not just its statistical significance, will decide how widely doctors use it.
    Amgen press release - positive topline Phase 3 results for dazodalibep in moderate-to-severe systemic Sjogren's disease. — September 2026 · publ. September 2026 · source ↗
Sources
Generated September 28, 2026