TLDR
- Xencor (XNCR) stock rose about 25% Monday to $31.36 after Phase 1 data for XmAb819 in kidney cancer.
- The drug showed a 45.5% confirmed response rate and 82% six-month progression-free survival at the chosen dose.
- The company plans to talk to the FDA about accelerated approval in the first half of 2027.
- XNCR hit a 52-week high of $33.06 during the session, up from a $25.18 close.
- Analysts hold a “Moderate Buy” view with a $34.00 average price target.
Xencor (XNCR) stock climbed about 25% on Monday to $31.36, up $6.18 on the day. The move followed new Phase 1 data for XmAb819, its experimental cancer drug. Earlier in the session, the stock touched a 52-week high of $33.06.
The previous close was $25.18. At the intraday high, the gain was about 31%. By late morning, it had eased back to the mid-20s in percentage terms.
The data covered patients with advanced clear cell renal cell carcinoma. XmAb819 is a bispecific T-cell engager aimed at tumors that carry the ENPP3 marker. Xencor shared the results at the European Society for Medical Oncology Congress in Madrid.
The company picked 400 mcg/kg as its proposed intravenous dose for Phase 3. That choice rests on a 45.5% confirmed objective response rate. The unconfirmed rate was 55%.
What the trial showed
The six-month progression-free survival estimate came in at 82%. The study enrolled 119 patients across 11 dose levels as of September 1. Three dose levels moved into expansion cohorts covering 68 patients.
Those patients were heavily treated before joining. They had a median of three prior lines of therapy. That makes the response numbers a bit harder to dismiss.
Of 25 patients with a confirmed response, one had a complete response. The other 24 had partial responses. Nineteen of those responses were still ongoing at the data cut.
Median time on treatment was seven months. The drug was generally well tolerated, by the company’s account. About 5.9% of patients stopped treatment because of related side effects.
Grade 3 or higher related events hit 72.1% of patients. These were mostly liver enzyme increases and rash. That figure is worth a look for anyone sizing up the risk.
What comes next
Xencor plans to speak with the FDA in the first half of 2027. The talks will cover a possible accelerated approval path in key patient subgroups. The company also wants a global randomized study against tivozanib.
That study would enroll patients who progressed after PD-(L)1 and VEGFR TKI treatment. Xencor expects to start a registration-enabling study by the end of 2027. It says its cash runway stretches into 2029.
Wall Street was already leaning positive before the news. MarketBeat lists one Strong Buy, six Buy, three Hold and one Sell rating. The consensus target is $34.00.
Raymond James raised its target to $46.00 in September with a strong-buy rating. Cantor Fitzgerald lifted its target to $44.00 in August. Truist raised its target to $29.00 from $27.00.
The stock’s 50-day moving average is $25.37. Its 200-day average is $18.43. Market value stood near $2.21 billion on Monday.
In August, Xencor reported a loss of $0.29 per share, against a forecast loss of $0.80. Revenue was $51.22 million, compared with expectations of $18.89 million. As of Monday, XNCR traded at $31.36 in real-time data.
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