Key Takeaways
- Xencor shares jumped 31% after its kidney cancer drug XmAb819 had a 45.5% confirmed response rate in heavily pre-treated patients at the dose it chose.
- The data gives Xencor a credible case for accelerated approval in patients who have run out of standard options.
- The response rate at that dose comes from just 11 patients, and 72.1% of patients across the expansion doses had serious side effects tied to the drug.
- Xencor will discuss accelerated approval with the FDA in the first half of 2027, the same half its full 400 mcg/kg data is due.
Xencor (XNCR) shares soared 31% this morning after its kidney cancer drug, XmAb819, shrank tumors in nearly half of heavily pre-treated patients at its chosen dose.
City of Hope’s Sumanta Pal, a study investigator who presented the data at ESMO on Sunday, put it plainly:
“XmAb819 has demonstrated impressive antitumor activity in a heavily pre-treated and difficult-to-treat patient population with advanced clear cell renal cell carcinoma.”
What exactly happened
At 400 mcg/kg, Xencor’s pick for late-stage trials:
- 45.5% of patients had a confirmed response (55% counting one more that isn’t confirmed yet)
- An estimated 82% were progression-free at six months
Tivozanib, the drug XmAb819 will be tested against, posted 10.5% and 41% on those measures in a similar group in the TiNivo-2 trial. (These are different trials, so it’s a rough guide.)
The fine print: that 45.5% comes from just 11 patients. And across all 68 patients at the three expansion doses, 72.1% had Grade 3 or worse side effects tied to the drug, mostly liver enzyme spikes and rash.
Still, only 5.9% stopped treatment because of them. Keeping patients on the drug is a big part of the test for a T-cell engager in a solid tumor.
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The road to approval
Xencor says no treatment is recommended in the guidelines for patients whose cancer has progressed after a PD-(L)1 inhibitor and at least two VEGFR TKIs. In that group, XmAb819 had a 45% confirmed response rate across 42 patients.
That’s the case Xencor will take to the FDA on accelerated approval in the first half of 2027. It also plans to start a randomized trial against tivozanib by the end of 2027. That would make XmAb819 its third XmAb 2+1 drug in late-stage trials.
Paying for it
Xencor had $486 million in cash and short-term investments at the end of June…
…and it says that money lasts into 2029. But it’s burning cash faster: free cash flow was negative $124 million in the first half of 2026, more than double the $54.5 million a year earlier.
Trials aren’t cheap, so I wouldn’t be surprised to see Xencor sell stock after a jump like this.
The upshot
The pop looks earned to me. A 45% response rate in patients who’ve run out of standard options gives Xencor a credible shot at accelerated approval for a drug it owns outright.
Of course, 11 patients is a small base. The next real test is the full 400 mcg/kg data from at least 20 patients, due in the first half of 2027.
So what is Xencor stock actually worth?
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