REDWOOD CITY, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced updated clinical data for elironrasib, a RAS(ON) G12C-selective inhibitor, in previously treated patients with KRAS G12C non-small cell lung cancer (NSCLC) who had received a prior KRAS(OFF) G12C inhibitor. These results will be highlighted in an oral presentation at the AACR-NCI-EORTC S ...

Core Insights - Revolution Medicines, Inc. has appointed Alan Sandler, M.D. as the chief development officer to enhance its leadership in developing targeted therapies for RAS-addicted cancers [1][2] - The company has also appointed Alicia Gardner and Gerwin Winter as regional general managers for the U.S. and Europe, respectively, to strengthen its global commercial capabilities [3] Company Overview - Revolution Medicines is a late-stage clinical oncology company focused on developing novel targeted therapies for patients with RAS-addicted cancers [4] - The company's R&D pipeline includes RAS(ON) inhibitors such as daraxonrasib (RMC-6236), elironrasib (RMC-6291), and zoldonrasib (RMC-9805), which are currently in clinical development [4] - The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be the next to enter clinical development, with additional opportunities focusing on RAS(ON) mutant-selective inhibitors [4]

Core Insights - Daraxonrasib shows promising clinical activity and durability in treating metastatic pancreatic ductal adenocarcinoma (PDAC) [1][2] - The company plans to initiate a three-arm Phase 3 trial in Q4 2025 to further evaluate daraxonrasib's efficacy [1][8] Clinical Data Summary - Long-term follow-up data for daraxonrasib monotherapy in second-line metastatic PDAC indicates a confirmed objective response rate (ORR) of 35% for RAS G12X mutation and 29% for any RAS mutation, with a disease control rate (DCR) of 92% and 95% respectively [5] - Median progression-free survival (PFS) was reported at 8.5 months and 8.1 months, while median overall survival (OS) was 13.1 months and 15.6 months [5] - In first-line treatment, daraxonrasib monotherapy showed an ORR of 47% and a DCR of 89% with a median follow-up of 9.3 months [5] Safety Profile - Daraxonrasib was generally well tolerated in both second-line and first-line settings, with no new safety signals identified [5][14] - The mean dose intensity for daraxonrasib was 85% in second-line and 81% in combination with chemotherapy [5][14] Combination Therapy Insights - The combination of daraxonrasib with Gemcitabine nab-Paclitaxel (GnP) demonstrated an ORR of 55% and a DCR of 90% with a median follow-up of 6.9 months [14] - The company aims to leverage the antitumor contribution of chemotherapy while maintaining sufficient dose intensity for daraxonrasib [6][14] Future Development Plans - The ongoing Phase 3 registrational trial, RASolute 302, is expected to complete global enrollment this year, with data readout anticipated in 2026 [5] - The planned RASolute 303 trial will evaluate daraxonrasib monotherapy and its combination with GnP against a control arm [8]

Core Insights - Revolution Medicines, Inc. reported significant advancements in its clinical trials for targeted therapies aimed at RAS-addicted cancers, particularly focusing on daraxonrasib for metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) [1][2][3] Clinical Development Progress - The company is executing pivotal trials with daraxonrasib, with the RASolute 302 trial for PDAC nearing completion of U.S. enrollment and continuing globally, expecting data readout in 2026 [1][2] - Daraxonrasib has received Breakthrough Therapy Designation from the FDA for previously treated metastatic PDAC with KRAS G12 mutations [2][8] - A registrational trial for daraxonrasib as a first-line treatment for metastatic PDAC is set to initiate this year, comparing it against chemotherapy [3][4] - The company plans to initiate a Phase 3 trial in 2026 for daraxonrasib combined with pembrolizumab for RAS mutant NSCLC [5][7] Financial Highlights - As of June 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $2.1 billion, including a $250 million tranche from Royalty Pharma [16] - Research and development expenses increased to $224.1 million for Q2 2025, up from $134.9 million in Q2 2024, primarily due to clinical trial and manufacturing costs [17] - General and administrative expenses rose to $40.6 million in Q2 2025 from $21.7 million in Q2 2024, driven by personnel-related costs and commercial preparation activities [18] - The net loss for Q2 2025 was $247.8 million, compared to a net loss of $133.2 million in Q2 2024 [19] Strategic Partnerships and Funding - The company entered a $2 billion flexible funding agreement with Royalty Pharma to support its global development and commercialization efforts [8][13] - A collaboration with Iambic Therapeutics aims to enhance drug discovery through AI capabilities [12][15] Pipeline and Future Directions - The company is advancing its pipeline with mutant-selective inhibitors elironrasib and zoldonrasib, with plans for pivotal trials in 2026 [6][10] - RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track for clinical readiness in 2025 [11][22]

Core Insights - The report maintains a positive outlook on small molecule drug conjugates (SMDCs) and related companies, highlighting their potential in cancer treatment due to their ability to enhance efficacy while reducing toxicity [1][5][17] - The report emphasizes the clinical advantages of SMDCs, including better tumor penetration, reduced toxicity to normal cells, and easier control over synthesis and costs compared to antibody-drug conjugates (ADCs) [5][11][12] - The report identifies domestic biopharmaceutical companies, particularly Affinivax, as leaders in the SMDC space, showcasing significant advancements in innovative cancer drug development [5][12][17] Industry Overview - The pharmaceutical and biotechnology sector has shown a relative price-to-earnings (P/E) ratio of 51.14 as of July 25, 2025, which is significantly higher than its historical low of 24.38, indicating a premium valuation compared to the broader market [19] - The report notes that the healthcare sector's valuation is 279% higher than the Shanghai Composite Index, reflecting strong investor interest and confidence in the industry [19] - Recent market performance indicates a 1.90% increase in the pharmaceutical and biotechnology sector from July 21 to July 25, 2025, ranking it 16th among 27 sub-industries [26][29] Company Focus - The report suggests monitoring companies involved in the SMDC space, including Affinivax, and those collaborating with them, such as Innovent Biologics and others, which are expected to benefit from the growing interest in innovative cancer therapies [5][17][18] - Specific companies highlighted for their innovative drug development capabilities include Innovent Biologics, Shunyi Pharmaceutical, and others, which are positioned to capitalize on the advancements in SMDC technology [5][18]

Core Insights - Revolution Medicines, Inc. has received Breakthrough Therapy Designation from the FDA for elironrasib, a selective inhibitor targeting KRAS G12C mutations in non-small cell lung cancer (NSCLC) [1][7] - The designation is based on promising results from the Phase 1 RMC-6291-001 clinical trial, which showed competitive antitumor activity and favorable safety profiles [2][4] - Elironrasib specifically targets the oncogenic RAS(ON) form of the KRAS G12C variant, which is present in approximately 12% of NSCLC cases [3][4] Company Overview - Revolution Medicines is focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes multiple RAS(ON) inhibitors [6] - The company is advancing elironrasib along with other candidates, including daraxonrasib and zoldonrasib, to address various RAS mutations [6] - The company aims to provide innovative treatment options for patients with significant unmet medical needs in oncology [3][4] Industry Context - NSCLC accounts for 80%-85% of all lung cancers, with KRAS mutations found in nearly 30% of NSCLC cases, making it a critical area for new therapeutic developments [4][5] - There are currently no FDA-approved RAS-targeted inhibitors for treating KRAS G12C NSCLC, highlighting the potential market opportunity for elironrasib [4][5] - The Breakthrough Therapy Designation is intended to expedite the development of new medicines for serious conditions, indicating the high unmet need in this therapeutic area [4]

Core Insights - Revolution Medicines has partnered with Royalty Pharma to secure $2 billion in flexible funding aimed at supporting its global development and commercialization strategy for RAS-addicted cancers [1][2][5] - The funding agreement allows Revolution Medicines to maintain full control over the development and commercialization of its RAS(ON) inhibitor portfolio, which is crucial for establishing new standards of care [1][2][3] Funding Agreement Overview - The funding consists of up to $1.25 billion in synthetic royalty monetization on sales of daraxonrasib and up to $750 million in corporate debt [3][5] - The agreement provides significant flexibility, with $1.25 billion available at the company's discretion, contingent on achieving specific milestones [3][5] Synthetic Royalty Details - Royalty Pharma will provide up to $1.25 billion in exchange for tiered royalties over 15 years on worldwide annual net sales of daraxonrasib, with decreasing royalty rates based on sales volume [6][13] - The first two tranches of $250 million each are payable before FDA approval, with the first tranche already received [6][13] Debt Facility Details - The debt facility consists of up to $750 million in senior secured term loans, with the first tranche available after FDA approval of daraxonrasib for metastatic pancreatic ductal adenocarcinoma [13] - The interest rate for the debt is based on the 3-month Standard Overnight Financing Rate (SOFR) plus 5.75%, with a SOFR floor of 3.50% [13] Cash Runway Update - Following the funding agreement, the company has removed its cash runway end date guidance, indicating improved financial stability [9] Company Background - Revolution Medicines is focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes multiple RAS(ON) inhibitors currently in clinical development [12]

Core Insights - Revolution Medicines, Inc. reported financial results for Q1 2025, highlighting progress in clinical trials and strategic priorities for the year [1][30][31] Clinical Development - The company is executing pivotal trials for daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC), with strong enrollment in the U.S. and initiation in the EU and Japan [1][2] - Plans are underway to advance daraxonrasib into first-line metastatic and earlier-line randomized pivotal trials for PDAC, expected to start in the second half of 2025 [3] - The company anticipates initiating pivotal combination trials for elironrasib and zoldonrasib in 2026 [4] - Recent data from zoldonrasib and elironrasib monotherapy in KRAS G12D and G12C mutant NSCLC patients show promising tolerability and antitumor activity [5][16] Combination Therapies - Clinical updates indicate encouraging results for combinations of daraxonrasib with pembrolizumab and elironrasib with pembrolizumab in NSCLC [6][19] - The combination of elironrasib with daraxonrasib demonstrated preliminary antitumor activity in patients previously treated with a KRAS G12C(OFF) inhibitor, with an objective response rate (ORR) of 62% [27][29] Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $2.1 billion [31][42] - Research and development expenses increased to $205.7 million from $118.0 million year-over-year, primarily due to clinical trial and manufacturing costs [32] - General and administrative expenses rose to $35.0 million from $22.8 million, attributed to personnel-related costs and commercial preparation activities [33] - The net loss for Q1 2025 was $213.4 million, compared to a net loss of $116.0 million in Q1 2024 [34] Strategic Initiatives - The company is enhancing its commercialization capabilities, appointing Anthony Mancini as chief global commercialization officer to strengthen its strategy in the U.S. and evaluate options for international reach [10][11] - Revolution Medicines is focused on advancing its pipeline of RAS(ON) inhibitors, with plans for future clinical development of RMC-5127, a G12V-selective inhibitor [37]