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Arcus Biosciences: Casdatifan Takes Center Stage After STAR-221 (NYSE:RCUS)
Seeking Alpha· 2025-12-17 14:02
Arcus Biosciences, Inc. ( RCUS ) is a biopharmaceutical company that develops drugs designed to be used in combination with other agents, rather than as standalone treatments. RCUS is undergoing a strategic reset after the discontinuation of itsMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Business M ...
Arcus Biosciences: Casdatifan Takes Center Stage After STAR-221
Seeking Alpha· 2025-12-17 14:02
Core Viewpoint - Arcus Biosciences, Inc. (RCUS) is undergoing a strategic reset following the discontinuation of its previous drug development strategy, focusing on combination therapies rather than standalone treatments [1]. Company Overview - RCUS is a biopharmaceutical company that specializes in developing drugs intended to be used in conjunction with other agents [1]. Strategic Changes - The company is implementing a strategic reset to adapt to the changing landscape of drug development and market needs [1].
RCUS Stock Down on Decision to Discontinue GILD Partnered Study
ZACKS· 2025-12-15 16:01
Key Takeaways RCUS fell 14.4% after discontinuing the phase III STAR-221 study in upper GI cancers following OS data.The domvanalimab combo failed to beat nivolumab plus chemo on survival, though safety was comparable.RCUS will pivot focus to casdatifan and other oncology and I&I programs, with cash funding into 2028.Shares of Arcus Biosciences, Inc. (RCUS) , a clinical-stage biopharmaceutical company, declined 14.4% following the announcement that its late-stage STAR-221 study was discontinued for futility ...
Arcus Biosciences, Inc. (NYSE:RCUS) Faces Setback but Remains Focused on Future Developments
Financial Modeling Prep· 2025-12-13 00:07
Core Viewpoint - Arcus Biosciences, Inc. is facing challenges following the discontinuation of its Phase 3 STAR-221 study, which has negatively impacted investor sentiment and stock performance, despite a previously strong market position. Group 1: Stock Performance - Truist Financial has set a price target of $30 for Arcus Biosciences (RCUS), indicating a potential upside of 34.74% from its current trading price of $22.27 [1][5] - Following the announcement of the study's discontinuation, RCUS stock experienced a significant decline, dropping to $21.77, a decrease of 13.42% or $3.38 from its previous value [2][3] - The stock fluctuated between $20.35 and $24 during the trading day, reflecting market volatility [3] Group 2: Study Discontinuation - Arcus announced the discontinuation of its Phase 3 STAR-221 study in collaboration with Gilead Sciences, as the Independent Data Monitoring Committee found no improvement in overall survival with the tested combination [2][5] - The decision to halt the study has adversely affected investor sentiment, despite the safety profiles being similar [2] Group 3: Future Focus - Arcus is shifting its focus to research and development investments in Casdatifan and its emerging inflammation and immunology portfolio [4][5] - The company's market capitalization is approximately $2.35 billion, with a trading volume of 5,619,062 shares on the day of the announcement [4]
Arcus Biosciences(RCUS) - 2025 FY - Earnings Call Transcript
2025-12-03 16:32
Arcus Biosciences (NYSE:RCUS) FY 2025 Conference December 03, 2025 10:30 AM ET Company ParticipantsYigal Nochomovitz - DirectorTerry Rosen - CEOJenn Jarrett - COOYigal NochomovitzOkay. Well, here we are. Another year, another conference. So welcome to the leadership team for Arcus. Very familiar faces. Terry Rosen, the CEO. Jen Jarrett, COO. Thanks for—And Pia.And Pia. Thank you. Hi, Pia. And I'm Yigal Nochomovitz. I'm a biotech analyst here at Citi. We've been covering Arcus now a long time, I think. Six y ...
Arcus Biosciences President Sells $2 Million in Stock Under Trading Plan
The Motley Fool· 2025-11-02 12:57
Core Insights - Juan C. Jaen, president of Arcus Biosciences, sold 96,859 shares for over $2 million, marking his largest sale in recent years [1][2][9] - The sale was executed under a structured trading plan, indicating it was not a reaction to market conditions [9][10] - Post-transaction, Jaen retains 367,220 direct shares and approximately 1.1 million indirect shares, reflecting continued investment in the company [4][10] Company Overview - Arcus Biosciences is a clinical-stage biotechnology firm focused on developing cancer immunotherapies, with a market capitalization of $2.1 billion and a revenue of $262 million over the trailing twelve months [5][6] - The company has a robust pipeline including several assets in Phase 1/2 clinical trials, such as Etrumadenant and Zimberelimab, and maintains collaborations with major biopharmaceutical firms like AstraZeneca [8][10] Financial Performance - The company reported a net income loss of $298 million over the trailing twelve months, but has a strong cash position of $841 million, positioning it well for future developments [5][11] - Arcus has experienced a 29% price change over the past year, indicating positive market sentiment [5] Market Context - The timing of Jaen's sale follows positive updates from Phase 2 and 3 trials, suggesting that the company is on a promising trajectory with its drug candidates [10] - Insider sales under structured trading plans are common in maturing biotech firms, particularly those with significant stock-based compensation [11]
Arcus Biosciences (NYSE:RCUS) 2025 Earnings Call Presentation
2025-10-06 14:00
Casdatifan Program Highlights - Arcus Biosciences has $927 million in cash to fund pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including the PEAK-1 study[13] - Casdatifan targets a $2 billion+ peak sales opportunity in IO-experienced ccRCC (PEAK-1) and a $3 billion+ peak sales opportunity in 1L ccRCC (eVOLVE-RCC002)[24] - Casdatifan monotherapy in late-line ccRCC shows a confirmed overall response rate (cORR) of 31% across all pooled cohorts (n=121), exceeding the 22% observed with belzutifan in LITESPARK-005[47] - Median progression-free survival (mPFS) for the pooled casdatifan monotherapy cohorts (n=121) is 122 months, more than double the 56 months seen with belzutifan in LITESPARK-005[67] Clinical Trial Updates - PEAK-1, a Phase 3 trial evaluating casdatifan plus cabozantinib in IO-experienced ccRCC, is currently enrolling with a target of approximately 700 patients[109] - The Phase 1b/3 eVOLVE-RCC002 study, sponsored by AstraZeneca, is evaluating casdatifan plus volrustomig in 1L advanced ccRCC, with Phase 1b currently enrolling[122] Biomarker Analysis - Serum EPO (sEPO) reduction is a strong marker for HIF-2α activity in ccRCC tumors, with a median best EPO reduction of 85% from baseline[154] - Patients with deeper sEPO reduction (>=85%) showed a cORR of 446% compared to 203% in those with less deep reduction[145] - Patients with deeper sEPO reduction (>=85%) had a mPFS of 146 months compared to 96 months in those with less deep reduction, with a hazard ratio of 060[150] Market Opportunity - The RCC market is projected to reach $13 billion by 2030, driven by increasing patient population, HIF-2α MOA introduction, and longer durations of therapy[198] - Arcus Biosciences estimates a potential $5 billion+ opportunity for casdatifan in 1L and IO-experienced ccRCC[204]
Arcus Biosciences(RCUS) - 2024 Q4 - Earnings Call Presentation
2025-07-08 05:48
Casdatifan (HIF-2α) Program - Casdatifan 100mg QD tablet showed a 33% confirmed ORR (Overall Response Rate) with short follow-up[15,19] - Casdatifan 100mg QD tablet showed a 15% primary progressive disease (PD) rate[15] - Casdatifan 50mg BID cohort showed a median Progression Free Survival (mPFS) of 9.7 months[15,25] - Casdatifan 50mg QD cohort showed mPFS not reached with 12 months follow-up[15,25] - The PEAK-1 Phase 3 study for Casdatifan is on track to initiate in Q2 2025[33] Domvanalimab (Anti-TIGIT mAb) Program - Domvanalimab plus Zimberelimab in 1L Gastric Cancer showed ~13 months mPFS vs 7-8 months for benchmark data[11] - In 1L PD-L1 High NSCLC, Domvanalimab + Zimberelimab vs Zimberelimab showed OS Hazard Ratio of 0.64[11,58] - EDGE-Gastric data showed 13.8 months median PFS in TAP ≥5% and 11.3 months median PFS in TAP < 5%[47] - STAR-221 is a Phase 3 study evaluating Domvanalimab + Zimberelimab + Chemo in 1L Gastric/GEJ/EAC, with data expected in 2026[51,52] CD73-Adenosine Axis Programs - Quemli ± Zim + G/nP in 1L Metastatic PDAC showed 15.7 months mOS vs 9.8 months for Synthetic Control Arm, representing a 37% reduction in risk of death[70]