ASTRAZENECA PLC (AZN) Form 6-K — Sep 21, 2026
AstraZeneca's rare disease unit Alexion received a positive CHMP opinion dated 21 September 2026 recommending EU approval of Klygefa (gefurulimab) as an add-on to standard therapy for adults with AChR antibody-positive generalised myasthenia gravis. The recommendation rests on the PREVAIL Phase III trial, in which Klygefa met its primary endpoint with a statistically significant improvement in MG-ADL total score versus placebo at week 26 (treatment difference -1.6, 95% CI -2.4 to -0.8, p<0.0001), with clinically meaningful benefit visible as early as week one and sustained through week 26.
Key figures
- Ci 95
- -2.4 to -0.8
- Dosing
- once weekly subcutaneous self-administration
- P value
- <0.0001
- Trial countries
- 20
- Primary endpoint week
- 26
- Trial patients enrolled
- 260
- Gmg patients europe top5
- 82500
- Achr positive patients europe top5
- 66000
- Mg adl treatment difference week26
- -1.6
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.