- Trial Phase
- Approved (Phase 4 ongoing)
- Time to Market
- Already approved and commercially available since 2010. Label expansions (methotrexate co-administration in 2022) are already in place. Any future label updates for shortened infusion time or monthly dosing would require FDA supplemental filings, but no submission has been publicly confirmed.
- Why 4/10
- KRYSTEXXA is an already-approved, commercial-stage drug with no pending PDUFA or pivotal readout. The next catalyst is real-world evidence presentations at ACR Convergence 2026 (November 2026), which is not a binary event. Per the rubric, an approved drug with no pending regulatory decision scores 3-5. KRYSTEXXA is a meaningful growth driver but represents only about 4% of Amgen's quarterly revenue, so impactScore is 4.
KRYSTEXXA is a steady commercial growth story within Amgen's portfolio, but with no pending PDUFA or pivotal readout, there is no near-term binary catalyst for the stock. Watch for potential FDA supplemental filings for monthly (Q4W) dosing or shortened 60-minute infusion, which could incrementally expand the market. Also monitor Amgen's quarterly earnings for continued sales growth trajectory. The ACR Convergence 2026 real-world evidence presentations (November 2026) are informational, not stock-moving events.
Price Chart
Executive Summary
KRYSTEXXA (pegloticase) is an FDA-approved biologic for chronic gout that is refractory to conventional oral therapies. Originally approved in 2010 and now owned by Amgen (acquired via the $27.8B Horizon Therapeutics deal in 2023), it is the first and only approved biologic for uncontrolled gout. The drug works by breaking down uric acid in the blood. Sales are growing strongly (Q3 2026: $419M, +31% YoY), driven by higher net selling price and the 2022 label expansion for co-administration with methotrexate, which improves efficacy. Phase 4 studies support shorter infusion times and monthly dosing, which could further expand use. However, KRYSTEXXA is a small part of Amgen's massive $39B+ annual revenue base, and there are no binary catalysts ahead, making it a steady commercial contributor rather than a stock-moving event driver.
How It Works
KRYSTEXXA is a lab-engineered enzyme (uricase) that breaks down uric acid in the blood. It is given as an intravenous infusion and is PEGylated (coated with a molecule called PEG) to help it stay in the body longer and reduce immune reactions. It is the first and only approved biologic for uncontrolled gout.
Trial Status
KRYSTEXXA was originally FDA-approved in September 2010 for chronic gout refractory to conventional therapy. In July 2022, the FDA approved co-administration with methotrexate to reduce anti-drug antibodies and improve response rates. Multiple Phase 4 studies are complete or ongoing: the AGILE trial (NCT04511702) showed that shortening infusion time from 120 minutes to 60 minutes is safe and effective (presented at ACR 2024). The FORWARD open-label trial (NCT04762498) showed monthly (every-4-week) dosing with higher pegloticase doses is feasible (presented at EULAR 2025). The FORWARD II double-blind non-inferiority trial (NCT06229145) comparing every-4-week vs every-2-week dosing completed primary data collection in July 2025. Real-world evidence is being presented at ACR Convergence 2026 (November 2026).
The Two-Sided Case
Upcoming Catalysts
- Real-world evidence data presentations at ACR Convergence 2026 (November 2026) - not a binary catalyst
- Potential FDA supplemental filing for monthly (Q4W) dosing regimen if FORWARD II results support it - no timeline confirmed
- Potential FDA supplemental filing for shortened 60-minute infusion time based on AGILE trial - regulatory filings reported as 'underway' as of November 2024, but no update since
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report