Recent Updates
Recently added Catalysts
VIR Positive Sentiment

Vir Biotechnology Announces PSMA-targeted PRO-XTEN® Dual-masked T-cell Engager VIR-5500 Received FDA Fast Track Designation for the Treatment of Prostate Cancer

Key Takeaway: Vir Biotechnology announced that the FDA has granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN® dual-masked T-cell engager. This designation is specifically for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). The drug is being co-developed with Astellas Pharma, indicating a strong partnership in its advancement.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA Fast Track designation for VIR-5500 is a significant milestone.
  • VIR-5500 targets late-line metastatic castration-resistant prostate cancer.
  • Collaboration with Astellas Pharma enhances development potential.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+85%
120-day peak, hindsight
Typical move
9.5%
average across 6 past catalysts
Lead asset
Tobevibart
Phase 3 · Viral Hepatitis

Full Press Release Details

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN® dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is being co-developed by Astellas Pharma Inc. and Vir Biotechnology through a global strategic collaboration. “Receiving Fast Track designation reflects the potent

Frequently Asked Questions

What is VIR-5500?

VIR-5500 is a PSMA-targeted PRO-XTEN® dual-masked T-cell engager designed for prostate cancer treatment.

What designation did the FDA grant VIR-5500?

The FDA granted Fast Track designation to VIR-5500 for treating late-line metastatic castration-resistant prostate cancer.

Who is developing VIR-5500?

VIR-5500 is co-developed by Vir Biotechnology and Astellas Pharma through a global collaboration.

What type of cancer is VIR-5500 targeting?

VIR-5500 targets late-line metastatic castration-resistant prostate cancer (mCRPC).

Last updated: Oct 8, 2026