Clinical TrialJul 16, 2026, 08:01 AM
Grifols Initiates Two Phase 3 Trials for Ig Therapies
AI Summary
Grifols announced the dosing of the first patients in two separate Phase 3 clinical trials, SIGMA and XPERT. These trials aim to expand the U.S. labels for its key immunoglobulin therapies, GAMUNEX-C and XEMBIFY. The SIGMA trial will evaluate GAMUNEX-C for secondary immunodeficiency, while the XPERT trial will assess XEMBIFY's non-inferiority to GAMUNEX-C for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), potentially offering more treatment options for patients.
Key Highlights
- Grifols initiated two Phase 3 trials for GAMUNEX-C and XEMBIFY.
- SIGMA trial evaluates GAMUNEX-C for secondary immunodeficiency (SID).
- XPERT trial compares XEMBIFY to GAMUNEX-C for CIDP treatment.
- Trials aim to expand U.S. labels for both immunoglobulin therapies.
- SIGMA trial includes 50 participants with B-cell CLL, MM, or NHL.
- XPERT trial involves approximately 40 CIDP patients across 20 sites.
- XEMBIFY sales grew nearly 60% year over year in 2025.
Price Impact
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