Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
Phase 3 PSMAddition showed that adding 177Lu-PSMA-617 to ADT plus an ARPI improved radiographic progression-free survival in PSMA-positive mHSPC. Health-related quality of life and pain were largely maintained.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07751133 |
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07503379 |
Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07389174 |
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07112612 |
Minimal Residual Disease Used in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer |
NOT_YET_RECRUITING |
