---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-011011"
form_type: "8-K"
ticker: "RANI"
cik: "0001856725"
company_name: "Rani Therapeutics Holdings, Inc."
filed_at: "2024-02-05T23:59:59+00:00"
generated_at: "2026-06-06T09:21:36.764636+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Rani announces positive Phase 1 topline results for oral ustekinumab biosimilar RT-111

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-011011
- form_type: 8-K
- ticker: RANI
- cik: 0001856725
- company_name: Rani Therapeutics Holdings, Inc.
- filed_at: 2024-02-05T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1856725/000095017024011011/0000950170-24-011011-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1856725/000095017024011011/rani-20240205.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-011011
- JSON: https://secwatch.observer/filing/0000950170-24-011011.json
- Plain text: https://secwatch.observer/filing/0000950170-24-011011.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.