Ultragenyx Cuts 130 Jobs After Setrusumab Fails; VERAXA Shareholders OK Financing Changes
Ultragenyx cuts 10% of staff after setrusumab Phase III misses; VERAXA Biotech shareholders approve capital and board changes at EGM.
setrusumab
DrugAlso known as: UX 143, UX143
Drug Profile
Setrusumab is an investigational anti-sclerostin monoclonal antibody being developed for osteogenesis imperfecta (OI). In June 2025, the FDA granted Breakthrough Therapy designation for setrusumab in children and adults with OI based on fracture risk reduction data from phase 2b and phase 3 studies. It is not yet approved for marketing.
- Drug Class
- Investigational anti-sclerostin monoclonal antibody
- Approval Status
- Investigational (FDA Breakthrough Therapy designation granted June 2025; no approved OI treatment)
- Mechanism of Action
- Monoclonal antibody targeting sclerostin to modulate bone formation pathways.
- \Children and adults with osteogenesis imperfecta (investigational)\
Related News
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Two securities class action lawsuits have been filed against NASDAQ-listed biopharmaceutical companies Ultragenyx and Vistagen. Both cases allege defendants made misleading statements about clinical trial results for key drug programs. Investors face deadlines in March and April 2026 to request lead plaintiff status.
Ultragenyx launches restructuring plan as class action targets setrusumab disclosures
Ultragenyx began a restructuring plan that includes a 10% workforce reduction and termination of UX143 manufacturing agreements. The company also faces a class action tied to setrusumab disclosures.
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Class action lawsuits allege false statements about clinical trial results and regulatory prospects at Atara Biotherapeutics, Ultragenyx, Mereo BioPharma, and Vistagen Therapeutics. The complaints cite failed Phase 3 studies for setrusumab in Osteogenesis Imperfecta and fasedienol for social anxiety disorder, along with manufacturing issues affecting Atara's tabelecleucel application. Investors have deadlines ranging from April to May 2026 to seek lead plaintiff status.
Ultragenyx Faces Lawsuits Over Trial Data as UX111 Gene Therapy Advances
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Ultragenyx Faces Securities Class Action After Phase 3 Setrusumab Trial Failures
Ultragenyx Pharmaceutical faces federal securities class action lawsuits following the failure of Phase 3 Orbit and Cosmic studies for setrusumab in Osteogenesis Imperfecta, with stock falling over 42% after December 2025 results announcement.
Related Clinical Trials
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06636071 |
Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05768854 |
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05312697 |
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta |
TERMINATED | PHASE2 |
| NCT05125809 |
Setrusumab vs Placebo for Osteogenesis Imperfecta |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT03118570 |
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 |
COMPLETED | PHASE2 |