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BOSTON - Xencor, Inc. (NASDAQ:XNCR), a $922 million market cap biotechnology company, reported initial results from its ongoing Phase 1 study of XmAb819, a novel T-cell engaging bispecific antibody targeting ENPP3, in patients with advanced clear cell renal cell carcinoma (ccRCC). The company’s stock has shown strong momentum with a 36% gain over the past six months, according to InvestingPro data.
According to data presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, XmAb819 demonstrated a 25% overall response rate within the target dose range in heavily pretreated patients. The company has selected its first dose-expansion cohort and continues dose escalation to identify a second expansion cohort. While Xencor maintains a strong balance sheet with more cash than debt, InvestingPro analysis indicates the company is not yet profitable, with analysts expecting continued losses this year.
The study included 69 patients across 10 intravenous and 5 subcutaneous dose cohorts. Patients had received a median of 4 prior lines of therapy, with all having previous anti-PD1 and VEGF-TKI treatment.
Among 20 efficacy-evaluable patients treated at doses within the target range, five achieved partial responses, with a 70% disease control rate. All five responding patients remain on treatment, along with half of all evaluable patients in the target dose range.
The most common treatment-related adverse events were cytokine release syndrome, rash, and gastrointestinal issues, primarily Grade 1 or 2 in severity. Grade 3 treatment-related events included rash (16%), liver enzyme elevations (7%), and cytokine release syndrome (4%). No treatment-related neurotoxicity cases were observed.
Four patients required dose reductions due to treatment-related adverse events, while three discontinued treatment for the same reason. The company noted that early dosing errors affected 18 patients, resulting in higher than expected drug concentrations. Xencor has completed site retraining and plans to implement a low concentration formulation in the first half of 2026.
Xencor aims to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study in advanced ccRCC in 2027.
This information is based on a press release statement from Xencor.
In other recent news, Xencor, Inc. is set to present initial results from its Phase 1 study of XmAb819, a bispecific antibody for treating clear cell renal cell carcinoma, at the AACR-NCI-EORTC Conference. The company plans to discuss these preliminary findings during a webcast on October 24. Ahead of this event, Cantor Fitzgerald reiterated an Overweight rating with a $40 price target on Xencor, emphasizing a strong outlook despite early market reactions to outdated data. In contrast, Barclays initiated coverage on Xencor with an Underweight rating and a $6 price target, expressing concerns about the company’s pipeline. Additionally, RBC Capital lowered its price target for Xencor from $32 to $15, though it maintained an Outperform rating, suggesting the current share price undervalues Xencor’s business prospects. These developments underscore the varied perspectives among analysts regarding Xencor’s future performance.
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