AB Science delays AML, ALS trial restarts after “for-cause” GCP inspection by EU health authorities
Bitget2026/09/29 06:10- AB Science revised its development plan following a “for cause” sponsor Good Clinical Practice inspection by French, Danish, Greek authorities.
- Clinical study restarts now depend on health-authority benefit-risk assessments, pending a final inspection report expected before year-end.
- Phase 1 AB8939 trial in acute myeloid leukemia targeted to resume in Q1 2027, subject to regulator clearance.
- Masitinib Phase 3 ALS trial restart pushed to Q4 2027, subject to a new inspection and regulator clearance.
- Half-year financial report publication delayed to Oct. 9, 2026 due to resources diverted to the inspection response.
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