SignalFDA/Bio
Xencor stock surges on positive cancer drug trial data
Xencor stock surges on positive cancer drug trial data.
Context
What happened: Xencor (NASDAQ:XNCR) shares jumped 24% Monday after it presented Phase 1 dose selection data for XmAb819, a bispecific T-cell engager for advanced clear cell renal cell carcinoma and ENPP3+ tumors.
Key numbers: 400 mcg/kg selected as proposed Phase 3 dose; 45.5% confirmed objective response rate; 55% unconfirmed objective response rate; 82%
Why it matters: Xencor plans to discuss a potential accelerated approval pathway with the FDA in the first half of 2027 and a global randomized study versus tivozanib, with a registration-enabling study anticipated by the end of 2027.
Market: +0.5% today ($91.17), +17.2% YTD, 0.7x vol — as of 20:17 UTC
What changed
Xencor (NASDAQ:XNCR) shares jumped 24% Monday after it presented Phase 1 dose selection data for XmAb819, a bispecific T-cell engager for advanced clear cell renal cell carcinoma and ENPP3+ tumors.
Why it matters
Xencor plans to discuss a potential accelerated approval pathway with the FDA in the first half of 2027 and a global randomized study versus tivozanib, with a registration-enabling study anticipated by the end of 2027.
Market: +0.5% today ($91.17), +17.2% YTD, 0.7x vol — as of 20:17 UTC