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Arcus Biosciences, Inc. (NYSE:RCUS), a $1.77 billion market cap biotechnology company, announced the first overall survival results from Arm A1 of its Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The announcement was made Sunday, according to a press release statement and details from a recent SEC filing. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, positioning it well for continued clinical development.
At the data cutoff of March 3, 2025, safety and efficacy outcomes were evaluated in all 41 patients enrolled and treated. The median follow-up period was 26.4 months. The study investigated a combination regimen of domvanalimab, zimberelimab, and chemotherapy. Efficacy was observed across all PD-L1 subgroups. With the company’s next earnings report due on November 11, 2025, InvestingPro analysts maintain a bullish consensus, with price targets ranging from $14 to $54 per share.
The median overall survival (OS) for all patients was 26.7 months, with a 24-month OS rate of 50.2% (90% confidence interval:36.3%, 62.6%). For patients with PD-L1 positive tumors (TAP ≥1%, n=29), the median OS was also 26.7 months, and the 24-month OS rate was 53.8% (90% CI:37.3%, 67.7%). In the PD-L1 high subgroup (TAP ≥5%, n=16), the median OS was not estimable, and the 24-month OS rate was 56.3% (90% CI:33.9%, 73.6%).
Median progression-free survival (PFS) for the overall group was 12.9 months (90% CI:9.8, 14.6), with a 24-month PFS rate of 25.9% (90% CI:14.8%, 38.5%). The confirmed overall response rate (ORR) was 59% (24 of 41 patients, 90% CI:45%, 72%).
No unexpected safety signals were observed at the time of data cutoff. The safety profile of the domvanalimab plus zimberelimab and chemotherapy regimen was consistent with that of anti-PD-1 plus chemotherapy. Immune-mediated treatment-emergent adverse events related to domvanalimab and/or zimberelimab occurred in 9 patients (22%), and infusion-related reactions were reported in 3 patients (7%).
All information is based on a press release statement and details disclosed in the company’s SEC filing.
In other recent news, Arcus Biosciences announced promising results from its Phase 2 EDGE-Gastric study, with patients in Arm A1 achieving a median overall survival of 26.7 months when treated with a combination of domvanalimab, zimberelimab, and chemotherapy. This data, which will be presented at the European Society for Medical Oncology Congress, marks a significant development in the treatment of gastric cancer. Additionally, Truist Securities has increased its price target for Arcus Biosciences to $39.00, citing the "best-in-class potential" of casdatifan in kidney cancer treatment. H.C. Wainwright has also reiterated its Buy rating on the stock, maintaining a price target of $24.00, following the company’s recent Investor Event that highlighted new monotherapy data for casdatifan. Cantor Fitzgerald has maintained its Overweight rating, emphasizing the company’s advancements in renal cell carcinoma treatment. These updates reflect Arcus Biosciences’ ongoing efforts to innovate in cancer therapies.
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