Arcus Biosciences (RCUS) Company Report

Arcus Biosciences' HIF-2α inhibitor, casdatifan (Cas), demonstrates superior efficacy over Merck's belzutifan (Bel) in late-line monotherapy for RCC, with a confirmed response rate of 35% (up to 45% for the 100mg dose) and a median PFS of approximately 12.2 months (up to 15 months for the 100mg dose), compared to Bel's just over 20% response rate and 5.6 months median PFS.
Casdatifan's PK/PD profile allows for harder target engagement and more durable suppression of erythropoietin production, lasting past 1 year, unlike belzutifan which loses its effect after about 9 weeks.
The ARC-20 umbrella study will provide key clinical updates, including data from the Cas plus cabo cohort between July and October, and initial data for Cas plus anti-PD-1 in frontline RCC, which has shown a 9% primary progressive disease rate.
The first registration study, PEAK-1, is evaluating casdatifan plus cabozantinib against cabozantinib alone in second-line RCC, with PFS as the sole primary endpoint, a strategy Arcus is confident in for regulatory approval.
HIF-2α inhibitors are expected to be used across all lines of therapy for RCC, driven by their non-toxic mechanism and lack of resistance development, indicating a large market opportunity.

1 day ago

Transcript

Arcus Biosciences Details Casdatifan's Clinical Progress and Competitive Advantages

RCUS

New Projects/Investments

Guidance Update

Arcus Biosciences highlighted its HIF-2α inhibitor, casdatifan, demonstrating superior efficacy over Merck's belzutifan in late-line monotherapy for renal cell carcinoma (RCC), with a confirmed response rate of 35% (45% for the 100mg dose) and median progression-free survival (PFS) of 12.2 months (over 15 months for the 100mg dose).
Casdatifan exhibits a non-toxic mechanism with on-target adverse events (anemia, hypoxia) comparable to belzutifan, and shows deeper and more durable suppression of erythropoietin production.
Key data readouts from the ARC-20 study are anticipated, including the Cas plus cabo cohort (relevant to the PEAK-1 Phase III study) between July and October 2026, and safety data for Cas plus anti-PD-1 plus CTLA-4 by year-end 2026.
Arcus plans to initiate its first Phase III study, likely combining casdatifan with anti-PD-1 and anti-CTLA-4, by the end of 2026, with the expectation that HIF-2α inhibition can be used in every line of therapy for RCC.

1 day ago

Transcript

Arcus Biosciences Details Casdatifan's Efficacy and Development Pipeline

RCUS

New Projects/Investments

Guidance Update

Arcus Biosciences' casdatifan (Cas) demonstrates superior efficacy over Merck's belzutifan in late-line monotherapy, with a 45% confirmed response rate for its 100mg dose compared to just over 20% for belzutifan, and a median PFS of above 15 months versus 5.6 months for belzutifan.
Casdatifan's toxicity profile, including anemia and hypoxia rates, is almost identical to Merck's belzutifan and is not expected to be a liability in Phase III studies.
Key upcoming clinical updates from the ARC-20 study include data for the Cas plus cabo cohort (relevant to the PEAK-1 Phase III study) expected between July and October 2026, and safety data for Cas plus anti-PD-1 plus CTLA-4 by the end of 2026.
The PEAK-1 registration trial, evaluating Cas plus cabozantinib versus cabozantinib alone, uses PFS as the sole primary endpoint and has no interim analyses to maximize success probability, a strategy confirmed by recent competitor data.
Arcus plans to initiate a Phase III study for casdatifan, anti-PD-1, anti-CTLA-4 by the end of 2026, anticipating that HIF-2 inhibition can be utilized across multiple lines of therapy, significantly expanding the market opportunity.

1 day ago

Transcript

Arcus Biosciences Highlights Clinical Progress and Financial Runway in Q4 2025

RCUS

Earnings

Guidance Update

New Projects/Investments

Arcus Biosciences reported a strong financial position with ~$1 billion in cash, providing funding until at least 2H 2028.
The company highlighted impressive Casdatifan data in late-line ccRCC, with the 100mg QD tablet cohort showing a confirmed overall response rate (CORR) of 45% and a median progression-free survival (mPFS) of 15.1 months. The PEAK-1 Phase 3 study is enrolling, targeting full enrollment by year-end.
Enrollment is complete for the Phase 3 study of Quemliclustat in 1L pancreatic cancer, with a readout anticipated in 1H 2027. This program has a market potential exceeding $4 billion.
Arcus is expanding its oral small molecule Inflammation & Immunology (I&I) portfolio, with first-in-human studies for an MRGPRX2 antagonist expected in 2026 and a TNF inhibitor in late 2026 / early 2027.
The Domvanalimab program is undergoing a futility analysis for its Phase 3 STAR-121 study, while other studies are winding down.

Feb 25, 2026, 9:30 PM

Presentation

Arcus Biosciences Details Casdatifan's Efficacy and Multi-Billion Dollar Market Potential

RCUS

New Projects/Investments

Revenue Acceleration/Inflection

Arcus Biosciences is positioning casdatifan as a best-in-class HIF-2\u03b1 inhibitor for clear cell renal cell carcinoma (RCC), with updated data from the ARC-20 study showing a 45% confirmed Overall Response Rate (ORR) and 15.1 months median Progression-Free Survival (PFS) for the 100mg QD cohort in late-line clear cell RCC.
The company's first Phase 3 study for casdatifan, PEAK-1, is actively enrolling and evaluates CAS plus cabozantinib in immunotherapy-experienced ccRCC, representing a fast-to-market strategy.
Arcus is also pursuing a TKI-free frontline strategy for casdatifan, with plans to initiate a Phase 3 study by the end of 2026, leveraging the consistently low rate of primary progression observed with casdatifan.
Casdatifan is projected to have a substantial market opportunity, with estimated peak sales potential of $2.5 billion in the IO-experienced setting (PEAK-1) and $3 billion or more in the first-line setting, potentially making it a $5 billion drug in first and second-line RCC alone.
Arcus is advancing its immunology portfolio, with two new programs (an MRGPRX2 antagonist, a TNF inhibitor, and a CCR6 antagonist) expected to enter clinical trials within the next 12 months.

Feb 25, 2026, 9:30 PM

Transcript

Arcus Biosciences Reports Q4 2025 Financials and Casdatifan Development Progress

RCUS

Earnings

Guidance Update

New Projects/Investments

Arcus Biosciences reported Q4 2025 GAAP revenue of $33 million and ended the quarter with $1 billion in cash. The company provided 2026 GAAP revenue guidance of $45 million-$55 million and expects its cash and investments to fund operations until at least the second half of 2028.
The company highlighted casdatifan as a best-in-class HIF-2\u03b1 inhibitor, presenting updated data from ARC-20 showing a 45% confirmed Overall Response Rate (ORR) and a median PFS of 15.1 months for the 100 mg QD cohort in late-line clear cell RCC.
Arcus is actively enrolling the PEAK-1 Phase 3 study for casdatifan in IO-experienced ccRCC and plans to initiate a second Phase 3 study by year-end 2026 for a TKI-free frontline regimen.
Casdatifan is projected to have a multi-billion dollar commercial opportunity, with estimated peak sales of $2.5 billion in the PEAK-1 setting and $3 billion or more in the first-line setting, potentially reaching $5 billion in first and second-line RCC alone.
Two of the company's inflammation and immunology programs are expected to enter the clinic over the next 12 months.

Feb 25, 2026, 9:30 PM

Transcript

Arcus Biosciences Reports Q4 and Full Year 2025 Results and Provides Casdatifan Development Update

RCUS

Earnings

Guidance Update

New Projects/Investments

Arcus Biosciences (RCUS) reported its Q4 and full year 2025 financial results and pipeline updates, emphasizing that 2026 is expected to be a transformative year for the company, focusing on its HIF-2\u03b1 inhibitor, casdatifan.
Casdatifan monotherapy demonstrated strong efficacy in late-line clear cell renal cell carcinoma (RCC), with the 100-milligram QD cohort achieving a confirmed Objective Response Rate (ORR) of 45% and a median Progression-Free Survival (PFS) of 15.1 months.
The company is actively enrolling patients in its PEAK-1 Phase III study for casdatifan plus cabozantinib in IO-experienced clear cell RCC and plans to initiate a Phase III study for a TKI-free casdatifan regimen in the frontline setting by the end of 2026.
Arcus estimates a multi-billion dollar market opportunity for casdatifan in RCC, projecting peak sales of $2.5 billion in the IO-experienced setting and over $3 billion in the first-line setting, totaling $5 billion in first and second-line RCC alone.

Feb 25, 2026, 9:30 PM

Transcript

Arcus Biosciences Reports Q4 and Full-Year 2025 Financial Results and Pipeline Update

RCUS

Earnings

Guidance Update

New Projects/Investments

Arcus Biosciences reported $1.0 billion in cash, cash equivalents, and marketable securities as of December 31, 2025, with a projected cash runway until at least the second half of 2028.
Updated data for casdatifan in late-line kidney cancer demonstrated a median progression-free survival (PFS) of 15.1 months and a confirmed overall response rate (cORR) of 45% for the 100mg once-daily cohort. Arcus plans to initiate a Phase 3 study in the first-line metastatic setting by the end of 2026.
For the fourth quarter of 2025, revenues were $33 million, and the net loss was $106 million.
The company expects GAAP revenue for the full year 2026 to be between $45 million to $55 million.

Feb 25, 2026, 9:05 PM

Press Release

Arcus Biosciences Presents New Casdatifan Data Showing Extended Progression-Free Survival in Kidney Cancer

RCUS

New Projects/Investments

An updated analysis of the ARC-20 study for casdatifan showed a median progression-free survival (mPFS) of 15.1 months and a confirmed overall response rate (cORR) of 45% for the 100mg QD tablet cohort.
In a pooled analysis of all four monotherapy cohorts (n=121), casdatifan demonstrated an mPFS of 12.2 months and a cORR of 35%.
Casdatifan's efficacy measures were better than published data from studies with the only marketed HIF-2a inhibitor, with PFS being two to nearly three times longer.
New biomarker data indicated a correlation between the magnitude and durability of serum erythropoietin (sEPO) suppression and clinical benefit, including cORR and PFS.
Casdatifan maintained an acceptable and manageable safety profile across all doses, with no unexpected safety signals observed.

Feb 23, 2026, 10:00 PM

Press Release

Arcus Biosciences Provides Pipeline and Financial Update at J.P. Morgan Healthcare Conference

RCUS

New Projects/Investments

Guidance Update

Arcus Biosciences has a cash position of $1 billion, providing a runway into the second half of 2028, which covers initial phase three readouts and proof of concept for early immunology programs.
The company's lead oncology program, casdatifan, a wholly-owned HIF-2α inhibitor, targets a $5 billion market opportunity in kidney cancer, with its fast-to-market PEAK-1 study aiming for enrollment completion by the end of 2026 and a front-line phase three study planned to commence by the end of 2026.
Another significant oncology program, quemliclustat, a CD73 inhibitor for pancreatic cancer, has completed enrollment for its PRISM-1 registrational trial, with readout expected in the first half of 2027, representing a $4 billion-plus commercial opportunity.
Arcus is expanding into immunology with an MRGPRX2 antagonist and a selective TNF receptor 1 inhibitor, both expected to enter the clinic by the end of 2026 or early 2027, with potential proof of concept for the MRGPRX2 antagonist by the end of 2026.
The discontinuation of the TIGIT program (STAR-221) due to lack of benefit has extended the company's cash runway, enabling further investment in its core wholly-owned programs.

Jan 14, 2026, 11:00 PM

Transcript

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