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Arcus Biosciences (RCUS)

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Earnings summaries and quarterly performance for Arcus Biosciences.

Recent press releases and 8-K filings for RCUS.

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
Arcus Biosciences provides update at J.P. Morgan Healthcare Conference 2026
RCUS
New Projects/Investments
Guidance Update
  • Arcus Biosciences reported approximately $1 billion in cash and investments as of September 30, 2025, adjusted for November 2025 financing, providing a funding runway until at least 2H 2028.
  • The company has two Phase 3 oncology programs: Casdatifan, a wholly-owned HIF-2a inhibitor, with a new Phase 3 trial (PEAK-1) in the 1L setting targeted for YE 2026. Clinical data for casdatifan showed a median PFS of 12.2 months in ARC-20 (Phase 1b/2). Quemliclustat, a small molecule CD73 inhibitor, is in Phase 3 for 1L pancreatic cancer (PRISM-1) with enrollment completed and a readout expected in 1H 2027.
  • Arcus plans for its first immunology molecules to enter the clinic in 2026, including an MRGPRX2 antagonist (expected in clinic in the next 6-9 months) and a TNF inhibitor (expected in clinic in late 2026 / early 2027).
  • Key near-term milestones include casdatifan monotherapy data at a medical conference in February 2026, casdatifan + cabo PFS data in the next 6-9 months, and initiating the first Phase 3 study for casdatifan in 1L RCC in the next 9-12 months.
Jan 14, 2026, 11:00 PM
Arcus Biosciences provides pipeline and financial update at JPMorgan Healthcare Conference
RCUS
Guidance Update
New Projects/Investments
  • Arcus Biosciences reported a strong financial position with $1 billion in cash, extending its runway into the second half of 2028, which covers key Phase 3 readouts and early immunology program proof-of-concepts.
  • The company is advancing its wholly-owned HIF-2α inhibitor, casdatifan, for kidney cancer, targeting a $5 billion market opportunity with a fast-to-market Phase 3 study (PEAK ONE) expected to enroll by year-end 2026 and a front-line Phase 3 study planned to start by year-end 2026.
  • Its Phase 3 oncology study, PRISM-1, for pancreatic cancer with quemliclustat, fully enrolled in September and anticipates readout in the first half of 2027, representing a $4 billion-plus commercial opportunity.
  • Arcus is expanding its pipeline into immunology with two new programs, an MRGPRX2 antagonist and a selective TNF receptor 1 inhibitor, both expected to enter the clinic by early 2027, with initial proof of concept for the MRGPRX2 antagonist by early 2027.
  • The discontinuation of the anti-TIGIT Phase 3 program (STAR-221) in GI cancer, due to lack of benefit, extended the company's cash runway.
Jan 14, 2026, 11:00 PM
Arcus Biosciences Provides Strategic Update on Oncology and Immunology Pipeline at JPMorgan Healthcare Conference
RCUS
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Arcus Biosciences is well capitalized with $1 billion in cash, providing a runway into the second half of 2028, which covers initial Phase III readouts and proof of concept for early immunology programs.
  • The company's highest value program, casdatifan (HIF-2α inhibitor), is wholly owned and targets a $5 billion market opportunity in kidney cancer, with a fast-to-market Phase III study (PEAK-1) expected to enroll by the end of 2026 and a front-line Phase III study planned to start by the end of 2026.
  • Another significant oncology program, quemliclustat (CD73 inhibitor) for pancreatic cancer, has its registrational trial (PRISM-1) fully enrolled as of September, with readout expected in the first half of 2027, representing a $4 billion+ commercial opportunity.
  • Arcus is expanding into immunology with two new small molecule programs, an MRGPRX2 antagonist and a selective TNF receptor 1 inhibitor, both expected to enter the clinic by the end of 2026 or early 2027, targeting multi-billion dollar markets.
  • The recent discontinuation of the STAR-221 TIGIT program in GI cancer, following an interim analysis showing no benefit, has extended the company's cash runway.
Jan 14, 2026, 11:00 PM
Arcus Biosciences Outlines 2026 Plans and Financial Outlook
RCUS
New Projects/Investments
Guidance Update
  • Arcus Biosciences' highest priorities for 2026 include the rapid enrollment of its PEAK-1 Phase 3 study evaluating casdatifan in IO-experienced ccRCC patients and the initiation of a first-line Phase 3 study for casdatifan.
  • The company plans at least three data presentations for casdatifan in 2026, including updated data from the Phase 1/1b ARC-20 study in February, updated data for casdatifan plus cabozantinib mid-year, and data from multiple ARC-20 cohorts in the second half of the year.
  • Arcus expects its first development candidate for inflammatory and autoimmune diseases, an oral MRGPRX2 antagonist, to enter clinical development in 2026.
  • With approximately $1 billion of cash and investments, Arcus anticipates being able to fund its planned operations until at least the second half of 2028.
Jan 7, 2026, 9:05 PM
Arcus Biosciences Discontinues Phase 3 STAR-221 Study and Shifts R&D Focus
RCUS
New Projects/Investments
Guidance Update
  • Arcus Biosciences has discontinued its Phase 3 STAR-221 study, conducted in partnership with Gilead Sciences, Inc., due to futility based on an interim analysis of overall survival in upper gastrointestinal cancers.
  • The company will now concentrate its R&D investment and resources on casdatifan, a potential best-in-class HIF-2a inhibitor, and its emerging small molecule inflammation and immunology (I&I) programs.
  • Multiple data readouts for casdatifan are anticipated in 2026, alongside the expected entry of a small molecule targeting MRGPRX2 into the clinic in the same year as part of its I&I portfolio.
  • Arcus expects to be able to fund its planned operations until at least the second half of 2028, supported by approximately $1 billion in cash and investments.
Dec 12, 2025, 1:30 PM
Arcus Highlights Casdatifan as Key Value Driver and Provides Pipeline Updates
RCUS
New Projects/Investments
Guidance Update
  • Casdatifan, Arcus's HIF-2 inhibitor, is positioned as the biggest value driver, with 100% ownership and clinical data showing PFS over 12 months in late-line settings, significantly outperforming Merck's belzutifan (5.6 months).
  • The company has three programs in Phase III, including casdatifan, an anti-TIGIT program, and a CD73 inhibitor.
  • The anti-TIGIT program (STAR-221) in upper GI cancers, fully enrolled in June 2024, is expected to read out in 2026, with Phase II data indicating overall survival greater than two years compared to 12-13 months for standard of care.
  • Arcus maintains a strong financial position with over $1 billion in cash, sufficient to fund initial Phase III readouts for all programs.
  • A decision on the optimal casdatifan combination for a frontline Phase III study is anticipated in the second half of next year (2026), following ongoing "bake-off" studies.
Dec 3, 2025, 3:30 PM
Arcus Provides Updates on Casdatifan, Anti-TIGIT, and Pipeline Programs
RCUS
New Projects/Investments
Guidance Update
  • Arcus's lead asset, Casdatifan (CAS), a HIF-2 inhibitor, is positioned as a major value driver due to its 100% ownership and demonstrated superior clinical profile compared to Merck's Belzutifan, with a PFS of over 12 months versus 5.6 months in late-line settings.
  • The company is advancing CAS into two Phase III studies for clear cell RCC, with the CAS+CABO combination study aiming to complete enrollment by the end of 2026 , and a decision on the best frontline combination for a Phase III study expected by the second half of 2026.
  • Arcus's anti-TIGIT program, Domvanalimab, has its first Phase III study (STAR-221) in upper GI cancers, which was fully enrolled in June 2024 and is expected to read out in 2026. This program features an Fc silent configuration, believed to offer a better safety profile.
  • The company also fully enrolled its Phase III study (PRISM1) for its CD73 inhibitor, Quemliclustat, in September 2025, ahead of schedule. Arcus maintains a strong financial position with over $1 billion in cash, covering initial Phase III readouts for all programs.
Dec 3, 2025, 3:30 PM
Arcus Biosciences Highlights Key Pipeline Assets and 2026 Milestones
RCUS
New Projects/Investments
Guidance Update
  • Arcus Biosciences' primary focus is casdatifan, a HIF-2 inhibitor, which has shown promising early data compared to Belzutifan, with more data expected in 2026 to inform its Phase III strategy.
  • The Phase III STAR-221 study for Domvanalimab (anti-TIGIT), which showed differentiated overall survival data in earlier studies, is anticipated to read out in 2026.
  • The Phase III study for Quemli (CD73 inhibitor) was fully enrolled in September, with a readout expected based on the typical overall survival of the control arm.
  • Arcus Biosciences has over $1 billion in capital to execute on its pipeline programs.
  • Enrollment for the Volrustomig (bispecific) combo study was paused due to adverse events, with ongoing assessment of current patients.
Dec 2, 2025, 9:40 PM
Arcus Provides Updates on Key Clinical Programs and Strategic Focus
RCUS
New Projects/Investments
Guidance Update
  • Casdatifan (HIF-2 inhibitor) is a primary focus, with significant data expected in 2026 to define its Phase 3 strategy in the second half of the year, showing superior data compared to belzutifan.
  • The anti-TIGIT program (DAM) has its Phase 3 STAR-221 study (1,050 patients) expected to read out in 2026, having been fully enrolled in June 2024. Additionally, the STAR-121 study (1,000 patients) will be fully enrolled by the end of 2025.
  • Arcus anticipates presenting more mature data for its casdatifan plus CABL combination next year, covering the full 44-patient dataset, which previously demonstrated a 40%+ response rate.
  • The company reported having $1 billion+ to execute its programs, and its CD73 inhibitor (Quemly) Phase 3 study was fully enrolled in September.
  • Enrollment for the Volroo combo was paused due to early AEs resembling CTLA-4 AEs, and the company is evaluating potential protocol amendments.
Dec 2, 2025, 9:40 PM

Quarterly earnings call transcripts for Arcus Biosciences.