Lupus: UCB and Biogen Release Positive Phase 3 Results in The Lancet
UCB and Biogen announced on Monday the publication in The Lancet of the phase 3 results of dapirolizumab pegol (DZP) in the treatment of systemic lupus erythematosus. The PHOENYCS GO study demonstrated a statistically significant improvement in disease activity at week 48 compared to placebo, supporting the continued development of the drug candidate.
Significant Improvement in Lupus Activity by Week 48
The PHOENYCS GO trial achieved its primary endpoint: 50% of patients treated with dapirolizumab pegol in addition to standard treatment showed a BICLA response (a composite measure of clinically meaningful improvement in lupus activity) at week 48, compared to 35% in the placebo group. This measure assesses clinically meaningful improvement across all affected systems without worsening in other areas of lupus. Favorable results for dapirolizumab pegol were also observed in several secondary endpoints, including severe lupus flares, serological markers (double-stranded DNA antibodies, C3 and C4 complement), as well as joint and skin symptoms. The trial also showed clinically significant improvements in fatigue, a symptom often identified by patients as one of the most debilitating aspects of lupus.
Confirmed Glucocorticoid-Sparing Potential
Free · Every morning
Technical market signals, before the opening bell.
Bullish and bearish momentum, analyst changes, stocks to watch — automatically computed from Euronext data.
✓ Before 9 AM every morning✓ Euronext data✓ AI-powered analysis
You're in — subscription confirmed!
Your first edition is on its way. Check your spam folder and add us to your contacts.
An error occurred.
Indicative data. No investment advice. Unsubscribe at any time.
Gratuit · chaque matin
Ne ratez plus rien sur vos actions
La tendance derrière les cours. L'essentiel des valeurs Euronext en quelques minutes.
📈les valeurs en mouvement, sur la durée
🎯les objectifs d'analystes qui évoluent
📰les actualités qui font bouger les cours
tendance · 6 séances
✓ C'est fait, vous êtes inscrit !
Votre première édition arrive bientôt. Pensez à vérifier vos spams.
Une erreur est survenue.
CAC 40 · SBF 120 · données indicatives · aucun conseil en investissement · désinscription à tout moment.
By week 48, a larger proportion of patients in the dapirolizumab pegol group had successfully reduced their dose of glucocorticoids from more than 7.5 mg/day to 7.5 mg/day or less. This result suggests a glucocorticoid-sparing effect of dapirolizumab pegol and is in line with a gradual reduction according to treatment guidelines. The safety profile of dapirolizumab pegol was generally favorable. Adverse events during treatment (82.6% in the dapirolizumab pegol group versus 75.0% in the placebo group) were more frequent with the drug candidate, while serious adverse events were less frequent (10.0% versus 14.8% respectively). Discontinuations due to adverse events remained low in both groups (4.7% and 3.7%).
Continuation of the Clinical Development Program
These positive phase 3 results support the continuation of the development of dapirolizumab pegol. UCB and Biogen are continuing the PHOENYCS FLY confirmation trial, currently recruiting patients. This trial is intended to support future regulatory submissions. Additional data from the PHOENYCS GO study are to be presented at the annual European Congress of Rheumatology (EULAR) this week.
SectorPharmacie et biotechnologies›Vaccins et laboratoires de recherche
Free · every morning · before 9am
Never miss a move on your stocks
The trend behind the prices · Euronext
✓ You're in! Check your spam folder.
An error occurred.
Context
Period
Period: S1 2026
Key reported figures
Revenue: 4 270 millions d'euros
Quarterly revenue: 4 270 millions d'euros
Revenue growth: 22,5 %
EBITDA: 1 685 millions d'euros
EBITDA margin: 40,7 %
Net income: 1 111 millions d'euros
2 821 millions d'euros
Guidance from the release
Based on the continued strong growth, revenue is expected to grow in the low-teens to mid-teens percentage range; Reflecting our strong execution and confidence in the outlook
Risks mentioned
Perte d'exclusivité de BRIVIACT aux États-Unis depuis février 2026 et en Europe attendue en août 2026
Ventes de VIMPAT au Japon affectées par l'arrivée de génériques fin 2025
Expiration en 2026 de la protection brevetaire de CIMZIA au Japon
Opportunities identified
Objectif de ventes maximales de BIMZELX relevé à au moins 7 milliards d'euros
Supériorité de BIMZELX sur risankizumab dans le rhumatisme psoriasique (étude BE BOLD)
FINTEPLA déposé dans le syndrome CDKL5 auprès de la FDA et de l'EMA, Phase 3 lancée dans le syndrome de Rett
Outlook / guidance
Management commentary: revenue is expected to grow in the low-teens to mid-teens percentage range at constant exchange rates (CER). Adjusted EBITDA² is expected to grow in the mid-teens to low-twenties percentage range at CER. Excluding other operating one-offs in 2025, adjusted EBITDA² growth is expected to be in the mid-twenties to low-thirties percentage range at CER.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
