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Merck in Talks to Buy Revolution Medicines Per Financial Times Report
ZACKS· 2026-01-09 18:06
Key Takeaways RVMD is in takeover talks with a valuation range of about $28B-$32B, though a deal is not yet finalized.Merck would add daraxonrasib, a late-stage RAS(ON) inhibitor being tested in pancreatic and lung cancers.MRK has pursued multiple acquisitions to offset Keytruda's 2028 loss of exclusivity.A recent Financial Times report stated that Merck (MRK) is in talks to buy Redwood City, CA-based cancer biotech, Revolution Medicines (RVMD) , in a transaction that could value RVMD for up to $32 billion. ...
RVMD Stock Hits a Record High on Rumored Takeover Interest
ZACKS· 2026-01-08 15:16
Key Takeaways RVMD stock surged nearly 29% after a WSJ report cited possible AbbVie acquisition interest.ABBV later denied takeover talks, though the report said a deal could value RVMD at $20B or more.Revolution Medicines develops RAS(ON) cancer drugs, with lead candidate daraxonrasib in late-stage studies.Shares of Revolution Medicines (RVMD) rose nearly 29% on Wednesday following a report issued by the Wall Street Journal (WSJ), as cited in a Yahoo Finance article, which stated that pharma giant AbbVie ( ...
Revolution Medicines Announces First Patient Randomized in the RASolute 304 Clinical Trial of Daraxonrasib in Resectable Pancreatic Ductal Adenocarcinoma Following Adjuvant Chemotherapy
Globenewswire· 2025-12-18 13:00
REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who have received surgery ...
Akari Therapeutics Highlights Preclinical Data Demonstrating Therapeutic Potential of Lead Candidate, AKTX-101, for Hard-to-Treat K-Ras Mutant Pancreatic Cancer
Globenewswire· 2025-12-09 13:40
Core Insights - Akari Therapeutics has announced promising preclinical data for its antibody-drug conjugate (ADC) AKTX-101, which targets Trop2 and shows potential in treating K-Ras G12V mutated pancreatic cancer, a highly lethal form of cancer with low survival rates [1][6] Industry Overview - Pancreatic cancer is one of the deadliest cancers, with approximately 60,000 new diagnoses and around 50,000 deaths annually in the U.S. The most common type, pancreatic ductal adenocarcinoma (PDAC), has limited treatment options, especially for K-Ras G12V mutation-driven tumors [2][3] Current Treatment Landscape - The standard treatments for K-Ras G12V-driven PDAC, such as FOLFIRINOX and gemcitabine plus nab-paclitaxel, yield poor outcomes with overall survival rates of 1.5 years and 1.3 years, respectively. There is a significant unmet need for targeted therapies in this area [3][4] AKTX-101 Mechanism and Efficacy - AKTX-101 is designed to deliver a novel RNA spliceosome modulating payload, PH1, to cancer cells expressing Trop2. This mechanism disrupts RNA splicing, which is crucial for cancer cell survival and proliferation. The ADC has shown significant cytotoxic potency in preclinical models, outperforming other investigational therapies [4][5] Future Development Plans - The company plans to present the preclinical data at a scientific conference and is advancing AKTX-101 towards a first-in-human trial expected to start in late 2026, with preliminary safety and efficacy data anticipated in 2027 [7]
Tango Therapeutics (NasdaqGM:TNGX) 2025 Conference Transcript
2025-11-19 17:32
Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics - **Focus**: Development of drugs based on the concept of synthetic lethality targeting tumor suppressor genes, with a lead program being vopimetostat, an MTAP-selective PRMT5 inhibitor [6][7] Key Points Product Development - **Vopimetostat**: - Developed for MTAP-deleted pancreatic ductal adenocarcinoma (PDAC) and lung cancer - Phase one/two study shows an overall response rate (ORR) of 27% across various difficult-to-treat cancers, with a specific ORR of 25% and median progression-free survival (PFS) of 7.2 months in second-line pancreatic cancer [7][8][13] - Comparison to current standard of care indicates favorable outcomes [7][8] Clinical Trials and FDA Interaction - **Second-line PDAC Pivotal Study**: - Plans to enroll approximately 300 patients, with a hierarchical design approved by the FDA allowing for fewer patients while still assessing PFS and overall survival (OS) [10][11][18] - The study aims to demonstrate a median PFS that is at least double the current range of 2 to 3.5 months [13][15] - The FDA meeting was described as positive, with agreement on the study design [18] Combination Studies - **Combination with RAS Inhibitors**: - Ongoing studies combining vopimetostat with daraxonrasib and zoldonrasib, with rapid enrollment noted [22][23] - The goal is to establish a first-line study in pancreatic cancer based on the combination's efficacy [35] Future Expectations - **Data Updates**: - Anticipated updates on combination studies and lung cancer data in the following year [24][43] - The company aims to show a convincing improvement in ORR for the combination therapies, targeting a response rate of 45-50% [27] Financial Position - **Cash Position**: - Current cash position is $153 million, with a recent raise of $225 million, providing a runway into 2028 for ongoing studies [62] Additional Insights - **Prognostic Factors**: - MTAP deletion linked to poorer prognosis in pancreatic cancer, which may influence study outcomes [13][14] - **Safety Profile**: - Combination therapies are reported to have clean adverse event profiles with minimal overlapping toxicity [46][47] - **Strategic Collaborations**: - Collaboration with Servier for MAT2A combination studies, with data disclosures dependent on Servier [40][41] This summary encapsulates the key aspects of Tango Therapeutics' conference call, highlighting their strategic focus, clinical developments, and financial health.
Revolution Medicines (NasdaqGS:RVMD) 2025 Conference Transcript
2025-11-18 10:32
Summary of Revolution Medicines Conference Call Company Overview - **Company**: Revolution Medicines - **Focus**: Development of inhibitors targeting RAS-driven cancers, which are the most common genetic cause of cancers [3][4] Current Pipeline - **Key Compound**: Daraxonrasib (formerly RMC-6236) - **Indications**: Primarily for pancreatic cancer, also targeting colorectal and non-small cell lung cancers - **Clinical Progress**: Three compounds in clinical trials, with daraxonrasib showing significant promise [3][4][9] Regulatory Engagement - **FDA Designations**: - Received Breakthrough Therapy Designation and Orphan Drug Designation for daraxonrasib - Awarded the Commissioner's National Priority Voucher, indicating accelerated review for NDA submission [4][5][7] Clinical Trials - **Pivotal Phase 3 Trial**: - Focused on second-line pancreatic cancer with daraxonrasib - **Endpoints**: Overall survival (OS) and progression-free survival (PFS) - **Current Status**: Fully enrolled, with results expected in 2026 [8][10][13] - **Comparative Data**: - Daraxonrasib monotherapy showed median PFS of over 8 months and median OS of 13-15 months compared to standard chemotherapy's 3 months PFS and 6 months OS [9][10] - **Additional Trials**: - Initiated trials for front-line pancreatic cancer and adjuvant treatment for resectable disease [15][17][26] Market Opportunity - **Pancreatic Cancer Statistics**: - Approximately 56,000 new diagnoses annually in the U.S. - About 15% are resectable, translating to roughly 7,500 patients who could benefit from new treatments [26][27] Combination Strategies - **Combination Trials**: - Exploring daraxonrasib in combination with cytotoxic chemotherapy and other agents like zoldorasib, a G12D selective inhibitor [29][30] Financial Position - **Cash Balance**: Approximately $1.9 billion - **Partnership with Roche**: $2 billion partnership, with $250 million drawn down, leaving $1.75 billion available for clinical programs [35] Future Directions - **Lung Cancer Trials**: - Ongoing trial for daraxonrasib in non-small cell lung cancer, with plans for a first-line regimen combining daraxonrasib with pembrolizumab and chemotherapy [32][33] Conclusion - Revolution Medicines is positioned strongly in the RAS-driven cancer space with a robust pipeline, significant regulatory support, and a solid financial foundation to pursue aggressive clinical strategies. The focus on daraxonrasib across multiple indications, particularly pancreatic cancer, highlights the company's commitment to addressing unmet medical needs in oncology [3][4][35]
Revolution Medicines, Inc. (RVMD) Presents at Guggenheim Securities 2nd Annual Healthcare Innovation Conference Transcript
Seeking Alpha· 2025-11-11 15:51
Core Insights - The company is currently conducting pivotal studies for daraxonrasib, with significant developments expected in the near future [1] - The most advanced registration study is the RASolute 302 trial for second-line pancreatic cancer, which is nearing completion of enrollment [2] - Promising Phase II data has been reported, and there is anticipation for the first registration data disclosure next year [2] Company Developments - The ongoing RASolute 302 trial is critical for the company's future, as it represents a key step towards potential market approval [2] - Efforts are being made to ensure that the positive outcomes from the Phase II study are effectively translated into the Phase III study [2]
Revolution Medicines (NasdaqGS:RVMD) FY Conference Transcript
2025-11-11 15:02
Summary of Revolution Medicines FY Conference Call Company Overview - **Company**: Revolution Medicines (NasdaqGS:RVMD) - **Focus**: Development of daraxonrasib for pancreatic cancer and other RAS-driven cancers Key Points Industry and Product Development - **Ongoing Trials**: The company is conducting pivotal studies for daraxonrasib, particularly focusing on pancreatic cancer with the RESOLUTE 302 trial nearing completion of enrollment [1][2] - **Patient Population**: The phase one/two trial patient population is similar to those in phase three trials, with slightly worse prognostic factors, suggesting a representative sample for the upcoming phase three study [2] Trial Mechanics and Endpoints - **Primary Goal**: The main goal of the RESOLUTE 302 trial is to demonstrate an overall survival (OS) benefit, which is prioritized by the FDA for pancreatic cancer [4] - **Statistical Modeling**: The trial is powered for OS, with a high likelihood of reaching significance for progression-free survival (PFS) in interim analyses [5] - **Hierarchical Testing Strategy**: The trial will first evaluate the G12 mutation subset (85% of pancreatic cancer cases) before analyzing broader RAS mutation groups [6] Regulatory Designations - **Breakthrough Therapy Designation**: Daraxonrasib has received breakthrough therapy designation and orphan drug designation, which may accelerate the regulatory review process [9] - **Priority Review Voucher**: The company has received a priority review voucher, potentially allowing for a streamlined review process post-NDA filing [10] Future Trials and Strategies - **First-Line Pancreatic Cancer**: Plans to initiate the RESOLUTE 303 study, a three-arm trial comparing standard chemotherapy, daraxonrasib monotherapy, and daraxonrasib plus chemotherapy [11][12] - **Efficacy Data**: Phase one/two data showed promising overall response rates (ORR) of approximately 47% for monotherapy and 55% for combination therapy with gemcitabine [13] Treatment Paradigm - **RAS-Driven Cancers**: The underlying biology of pancreatic cancer is RAS-driven, leading to the design of trials that leverage effective RAS inhibitors [14] - **Patient-Centric Approach**: The company emphasizes providing multiple treatment options to cater to diverse patient needs and preferences [17][18] Other Cancer Studies - **Non-Small Cell Lung Cancer**: The RESOLVE 301 study is enrolling patients with any RAS mutation, targeting a significant portion of non-small cell lung cancer cases [25][26] - **Combination Therapies**: Plans to initiate a registration study in first-line non-small cell lung cancer combining daraxonrasib with chemotherapy and pembrolizumab [27][31] New Developments - **Zoldonrasib**: A RAS G12D-selective ON inhibitor is being developed, with potential applications in combination with daraxonrasib and aggressive chemotherapies [39][41] - **Clinical Strategy**: The company is exploring various combination regimens to maximize treatment efficacy for patients with RAS mutations [42] Additional Insights - **Market Positioning**: The company aims to differentiate its products in a competitive landscape by combining therapies that enhance patient outcomes [31][35] - **Long-Term Vision**: Revolution Medicines is focused on addressing unmet needs in RAS-driven cancers, with ongoing evaluations of its pipeline and potential new therapies [35][36]
Revolution Medicines Posts Wider-Than-Expected Loss in Q3, Sales Nil
ZACKS· 2025-11-06 20:01
Core Insights - Revolution Medicines (RVMD) reported a Q3 2025 loss of $1.61 per share, which was wider than the Zacks Consensus Estimate of a loss of $1.39, and compared to a loss of 94 cents in the same quarter last year [1][9] - The company currently has no approved products and has not generated any revenue [1] - Year-to-date, RVMD shares have increased by 36%, outperforming the industry growth of 10% [1] Financial Performance - Research and development expenses reached approximately $263 million, reflecting a 73% year-over-year increase, primarily due to higher clinical study and manufacturing costs, as well as increased employee-related expenses [2] - General and administrative expenses were nearly $53 million, up 120% year-over-year, mainly driven by higher employee-related costs [2] - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $1.9 billion, down from $2.1 billion as of June 30, 2025 [3] Guidance - The company reiterated its full-year operating expenses guidance, expecting a range between $1.03 billion and $1.09 billion, which includes non-cash stock-based compensation expenses of $115-$130 million [4] Pipeline Developments - Revolution Medicines is developing multiple novel drugs targeting the active, GTP-bound form of RAS proteins, with daraxonrasib as the lead pipeline drug, designed to target major RAS mutation hotspots [5] - Daraxonrasib is currently being evaluated in two late-stage registrational studies: RASolve 301 for locally advanced or metastatic RAS-mutated NSCLC and RASolute 302 for second-line metastatic PDAC, with data readout from RASolute 302 expected in 2026 [6][9] - The company is expanding daraxonrasib's development in first-line settings for both NSCLC and PDAC, with studies expected to start before the end of 2025 and in 2026, respectively [7] - Additionally, RVMD is developing mutant-selective inhibitors like elironrasib and zoldonrasib, focusing on specific RAS mutations, and pursuing a combination strategy to enhance efficacy [8][10]
Revolution Medicines Reports Third Quarter 2025 Financial Results and Update on Corporate Progress
Globenewswire· 2025-11-05 21:02
Core Insights - Revolution Medicines, Inc. reported significant advancements in its clinical programs for RAS-addicted cancers, particularly with daraxonrasib, and aims to set new global standards of care for these patients [2][3][4] Financial Highlights - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $1.93 billion, which includes a $250 million royalty monetization tranche received in June 2025 [15] - Research and development expenses for Q3 2025 were $262.5 million, up from $151.8 million in Q3 2024, primarily due to increased clinical trial and manufacturing expenses [16] - General and administrative expenses rose to $52.8 million in Q3 2025 from $24.0 million in Q3 2024, driven by personnel-related costs and legal expenses [17] - The net loss for Q3 2025 was $305.2 million, compared to a net loss of $156.3 million in Q3 2024 [18] - The company reiterated its full-year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion [19] Clinical Development Updates - The RASolute 302 trial for daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) is nearing completion of enrollment, with data readout expected in 2026 [3][7] - The FDA granted daraxonrasib Orphan Drug Designation and Breakthrough Therapy Designation, supporting its expedited review [4] - The company is set to initiate RASolute 303, a Phase 3 trial for daraxonrasib in first-line metastatic PDAC, and RASolute 304, evaluating daraxonrasib as adjuvant treatment for resectable PDAC [5][6] - New data for elironrasib presented at a recent symposium showed promising response rates in patients with RAS G12C NSCLC [8] - Zoldonrasib is being evaluated in combination regimens and is expected to enter registrational trials in the first half of 2026 [10][11] Corporate Developments - Recent leadership appointments aim to enhance global development and commercialization capabilities [14] - The company is advancing its pipeline with next-generation RAS(ON) inhibitors, including RMC-5127, which is on track for a Phase 1 trial initiation in Q1 2026 [12]