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confidence high
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materiality 0.80
Rani announces positive Phase 1 topline results for oral ustekinumab biosimilar RT-111
Rani Therapeutics Holdings, Inc.
- RT-111 achieved 84% bioavailability vs subcutaneous Stelara injection; higher Cmax and shorter Tmax observed.
- No serious adverse events; mild transient AEs resolved without intervention; no participants withdrew.
- Celltrion holds right of first negotiation to acquire worldwide rights to RT-111 after successful Phase 1.
- This marks Rani's third successful Phase 1 trial using RaniPill technology; potential differentiated oral dosing for psoriasis.