other material
confidence high
sentiment positive
materiality 0.60
Citius Oncology corporate presentation confirms LYMPHIR launch in Q4 2025; $400M+ market
CITIUS ONCOLOGY, INC.
- LYMPHIR (denileukin diftitox) FDA-approved Aug 2024 for relapsed/refractory CTCL; first new systemic therapy since 2018.
- Commercial launch readiness nearing completion; ~$90M invested to date, 12-18 month inventory manufactured.
- New permanent J-code (J9161) secured; NCCN guidelines inclusion; sales force hiring underway.
- Clinical data: 36% ORR (9% CR, 27% PR), median 1.4 months to response, 6.5 months median duration of response.
- Ongoing combo studies: with KEYTRUDA (27% ORR in solid tumors) and CAR-T; prelim data expected Q4 2025/Q1 2026.