GlobeNewsWire
01 Jun 2026, 05:30 UTC · 1h ago
Source · https://www.globenewswire.com/news-release/2026/06/01/3304009/0/en/UCB-and-Biogen-Announce-Publication-in-The-Lancet-of-Positive-Dapirolizumab-Pegol-DZP-Phase-3-Study-Results-in-Systemic-Lupus-Erythematosus.html
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Dapirolizumab pegol (DZP) met its primary endpoint in the Phase 3 PHOENYCS GO study, showing statistically significant improvement in SLE disease activity compared to placebo. — Positive Phase 3 data for a drug targeting a high-need indication like SLE significantly increases the probability of future regulatory approval and commercial success.
+0.60DZP failed to meet its first key secondary endpoint (BICLA response at week 24). — Missing a key secondary endpoint introduces regulatory risk and suggests the drug's efficacy may take longer to manifest or be less consistent.
-0.30The drug demonstrated a glucocorticoid-sparing effect, allowing more patients to reduce their steroid dose compared to the placebo group. — Reducing steroid dependence is a highly valued clinical outcome in SLE treatment, enhancing the drug's competitive profile.
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UCB and Biogen are progressing with the confirmatory Phase 3 PHOENYCS FLY study to support future regulatory filings. — Confirms the pipeline is advancing toward the final hurdle for market entry, though the result remains speculative until the study concludes.
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Positive Phase 3 results for dapirolizumab pegol in SLE treatment were published in The Lancet.
Positive Phase 3 results for dapirolizumab pegol in SLE treatment were published in The Lancet.
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