Vir Biotechnology's VIR-5500 Wins FDA Fast Track for Late-line mCRPC

Vir Biotechnology, Inc. (VIR) filed an SEC Form 8-K — Other Events. Exhibit 99.1 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 SAN FRANCISCO, Calif. October 6, 2026 - Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.

Vir Biotechnology (VIR) announced FDA Fast Track designation for VIR-5500, a treatment for late-line mCRPC. Phase 3 trials are expected to start in 2027, according to the company.

H.C. Wainwright raised its price target for Vir Biotechnology (VIR) to $22 from $20, maintaining a Buy rating. The stock is up over 90% year-to-date. The firm increased its success probability for VIR-5500 in prostate cancer to 40%. Vir reported Q2 2026 net income of $80.1M, driven by an Astellas collaboration payment. Raymond James reiterated a Strong Buy rating with a $19 target.

Vir Biotechnology (VIR) has appointed David Liu as executive vice president and chief medical officer, effective October 12, 2026. Liu will oversee clinical development, medical affairs, and regulatory affairs for the company.

Vir Biotechnology, Inc. (VIR) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2026 Financial Results – Phase 2 SOLSTICE data presented at the EASL Congress showed that elebsiran and tobevibart achieved undetectable HDV RNA in 88% of participants with chronic hepatitis delta

Vir Biotechnology shares (NASDAQ:VIR) fell 5.6% after CFO Jason O’Byrne announced his departure. The company appointed Brent Sabatini, Senior VP and Chief Accounting Officer, as interim principal financial officer effective July 23, with O’Byrne staying through Aug. 3. Vir said it will search for a new CFO.