Revolution Medicines (RVMD) Company Report

Revolution Medicines' lead compound, daraxonrasib, received a Commissioner's National Priority Voucher and Orphan Drug Designation, signaling potential accelerated FDA review for its NDA submission.
The global Phase III RASolute 302 trial for daraxonrasib in second-line pancreatic cancer has fully enrolled and is expected to have a readout in 2026.
The company has initiated two additional global Phase III trials for daraxonrasib in pancreatic cancer: one for adjuvant treatment and RASolute 303 for first-line treatment.
A Phase III trial for zoldonrasib (G12D-selective inhibitor) in pancreatic cancer is expected to be initiated in H1 2026.
Revolution Medicines reported a strong financial position with approximately $1.9 billion in cash and access to an additional $1.75 billion from a partnership with Royalty Pharma.

Nov 18, 2025, 9:30 AM

Transcript

Revolution Medicines Provides Updates on Daraxonrasib Clinical Trials and Financial Position

RVMD

New Projects/Investments

Guidance Update

Revolution Medicines' lead compound, daraxonrasib, has received Breakthrough Therapy Designation, Orphan Drug Designation, and a Commissioner's National Priority Voucher, indicating potential for an accelerated FDA review of 1-2 months for its NDA submission.
The pivotal Phase 3 trial (RASolute 302) for daraxonrasib in second-line pancreatic cancer has fully enrolled, with a readout expected in 2026.
The company has initiated two additional global Phase 3 trials for daraxonrasib in pancreatic cancer: one for adjuvant treatment and another for first-line treatment (RASolute 303).
Revolution Medicines maintains a strong financial position with a cash balance of approximately $1.9 billion, including $1.75 billion available from a partnership with Roche.
A Phase 3 trial for zoldorasib, a G12D selective inhibitor, in pancreatic cancer is expected to be initiated in H1 2026.

Nov 18, 2025, 9:30 AM

Transcript

Revolution Medicines Provides Updates on Clinical Pipeline and Financial Position

RVMD

New Projects/Investments

Guidance Update

Revolution Medicines is advancing its pipeline for RAS-driven cancers, with daraxonrasib (formerly RMC-6236) receiving Breakthrough Therapy Designation, Orphan Drug Designation, and a Commissioner's National Priority Voucher for pancreatic cancer, signaling an accelerated FDA review for its NDA.
The global Phase 3 trial for daraxonrasib in second-line pancreatic cancer (RASolute 302) has fully enrolled, with a readout expected in 2026.
The company has initiated two additional global Phase 3 trials for daraxonrasib in pancreatic cancer: one for adjuvant treatment (initiated a few weeks prior to November 18, 2025) and another for first-line treatment (RASolute 303, initiated on November 18, 2025).
Revolution Medicines maintains a strong financial position with a cash balance of approximately $1.9 billion, including $1.75 billion available from a $2 billion partnership with Roche established in June.

Nov 18, 2025, 9:30 AM

Transcript

RVMD Provides Update on Daraxonrasib Clinical Trials and Pipeline

RVMD

New Projects/Investments

Product Launch

Guidance Update

Revolution Medicines' most advanced registration study, RESOLUTE 302 for second-line pancreatic cancer, is nearing completion of enrollment, with the first registration data disclosure expected next year. Daraxonrasib has received Breakthrough Therapy Designation, Orphan Drug Designation, and a Commissioner's Priority Review Voucher, potentially accelerating regulatory review to one to two months after NDA acceptance.
The company plans to initiate the RESOLUTE 303 study in first-line pancreatic cancer in 2025, a three-arm trial evaluating daraxonrasib monotherapy and combination with chemotherapy, building on promising 47-55% ORR data in first-line patients.
Revolution Medicines is also progressing with a registration study for daraxonrasib in first-line non-small cell lung cancer (NSCLC) in combination with chemo and pembrolizumab, and has an ongoing RESOLVE 301 study in second-line NSCLC for all RAS mutations.
Beyond daraxonrasib, the company is developing elironrasib (KRAS G12C ON inhibitor), which demonstrated a response rate above 40% and PFS above six months in third-line patients who progressed on a RAS(OFF) inhibitor, and zoldonrasib (RAS G12D-selective ON inhibitor) with plans for a first-line pancreatic cancer registration study.

Nov 11, 2025, 2:00 PM

Transcript

Revolution Medicines Provides Updates on Daraxonrasib and Pipeline Programs

RVMD

New Projects/Investments

Guidance Update

Revolution Medicines (RVMD) is nearing completion of enrollment for its pivotal RESOLUTE 302 study of daraxonrasib in second-line pancreatic cancer, an OS-driven trial that has received Breakthrough Therapy Designation, Orphan Drug Designation, and a Commissioner's Priority Review Voucher, potentially accelerating the review process.
The company plans to initiate the RESOLUTE 303 study for daraxonrasib in first-line pancreatic cancer in 2025, a three-arm trial supported by encouraging phase 1/2 data showing objective response rates of approximately 47% for monotherapy and 55% for combination with chemotherapy.
RVMD is also progressing daraxonrasib in non-small cell lung cancer (NSCLC), with the RESOLVE 301 study enrolling second-line patients with any RAS mutation, and plans for a first-line NSCLC registration study combining daraxonrasib with chemotherapy and pembrolizumab.
The pipeline includes elironrasib, a KRAS G12C ON inhibitor, which has demonstrated a response rate above 40% and PFS above six months as monotherapy in third-line patients who progressed on RAS(OFF) inhibitors. Additionally, zoldonrasib, a RAS G12D-selective ON inhibitor with a favorable safety profile, is slated for a registration study in first-line pancreatic cancer.

Nov 11, 2025, 2:00 PM

Transcript

Revolution Medicines Provides Update on Daraxonrasib Pivotal Studies and Pipeline Progress

RVMD

New Projects/Investments

Guidance Update

Revolution Medicines' daraxonrasib (RAS multi-inhibitor) second-line pancreatic cancer trial, RASolute 302, is nearing enrollment completion, with the main goal of demonstrating an OS benefit and data disclosure anticipated in 2026.
Daraxonrasib holds Breakthrough Therapy Designation, Orphan Drug Designation, and a Commissioner's National Priority Voucher for pancreatic cancer, potentially streamlining regulatory review to 1-2 months after NDA acceptance.
The company plans to initiate the RASolute 303 study in first-line pancreatic cancer in 2025, supported by promising first-line data showing an ORR of approximately 47% for monotherapy and 55% in combination with gemcitabine.
Revolution Medicines is also developing mutation-selective RAS(ON) inhibitors, including elironrasib (KRAS G12C ON inhibitor), which achieved a response rate above 40% and PFS above six months in patients who progressed on prior G12C inhibitors.
A registration study for zoldonrasib (RAS G12D-selective ON inhibitor) in first-line pancreatic cancer is planned, with its safety profile noted as "indistinguishable from placebo".

Nov 11, 2025, 2:00 PM

Transcript

Revolution Medicines Reports Q3 2025 Financials and Provides Extensive Pipeline Updates

RVMD

Earnings

Guidance Update

New Projects/Investments

Revolution Medicines reported a net loss of $305.2 million for Q3 2025 and reiterated its full-year 2025 GAAP net loss guidance of $1.03 billion to $1.09 billion. The company ended Q3 2025 with $1.93 billion in cash and investments, which includes a $250 million royalty monetization tranche received in June 2025.
Diraxonrasib, a RAS-on inhibitor, received an FDA Commissioner's National Priority Voucher and Orphan Drug designation for pancreatic cancer, adding to its existing Breakthrough Therapy status. The voucher program aims to accelerate review timelines.
The company presented encouraging initial results for Diraxonrasib in first-line metastatic pancreatic cancer, showing an objective response rate of 47% for monotherapy and 55% for combination therapy with GMP chemotherapy. Updated data, including preliminary durability, is expected in H1 2026.
Enrollment for the Resolute 302 Phase III trial in second-line metastatic pancreatic cancer is nearing completion, with data expected in 2026. Additionally, two new Phase III trials, Resolute 303 (first-line metastatic PDAC) and Resolute 304 (perioperative PDAC), are on track to initiate or have initiated in 2025.
Allieronrasib, a RAS-on G12C inhibitor, demonstrated a confirmed objective response rate of 42% and a median progression-free survival of 6.2 months in heavily pretreated non-small cell lung cancer patients.

Nov 5, 2025, 9:30 PM

Transcript

RVMD Announces Q3 2025 Financial Results and Pipeline Updates

RVMD

Earnings

New Projects/Investments

Guidance Update

Revolution Medicines reported a net loss of $305.2 million for Q3 2025 and reiterated its full-year 2025 GAAP net loss guidance of $1.03 billion to $1.09 billion. The company ended the quarter with $1.93 billion in cash and investments, including a $250 million royalty monetization tranche.
Diraxonrasib received Orphan Drug designation and an FDA Commissioner's National Priority Voucher for pancreatic cancer. The Phase 3 Resolute 302 trial for second-line metastatic pancreatic cancer is winding down enrollment, with data expected in 2026.
Initial results for Diraxonrasib in first-line metastatic pancreatic cancer showed an objective response rate of 47% for monotherapy and 55% for combination with chemotherapy, with updated durability data anticipated in the first half of 2026.
The company is on track to initiate the Phase 3 Resolute 303 trial for first-line metastatic pancreatic cancer in 2025 and the first-in-human trial for RMC 5127 in Q1 2026.
Allieronrasib demonstrated a confirmed objective response rate of 42% and median progression-free survival of 6.2 months in heavily pretreated G12C non-small cell lung cancer patients.

Nov 5, 2025, 9:30 PM

Transcript

Revolution Medicines Reports Q3 2025 Financials and Provides Pipeline Updates

RVMD

Earnings

Guidance Update

New Projects/Investments

Revolution Medicines reported a net loss of $305.2 million for Q3 2025 and ended the quarter with $1.93 billion in cash and investments. The company reiterated its full-year 2025 GAAP net loss guidance of $1.03 billion to $1.09 billion.
Diraxonrasib received Breakthrough Therapy status, Orphan Drug designation, and an FDA Commissioner's National Priority Voucher for pancreatic cancer. The Phase 3 Resolute 302 trial for second-line metastatic PDAC is nearing completion of enrollment with an expected data readout in 2026.
In heavily pretreated G12C non-small cell lung cancer patients, Allieronrasib monotherapy demonstrated a confirmed objective response rate of 42% and a median duration of response of 11.2 months.
The company plans to initiate a Zoledronrasib combination registration trial in first-line metastatic PDAC in the first half of 2026, and the first-in-human trial for RMC 5127 in Q1 2026.

Nov 5, 2025, 9:30 PM

Transcript

Revolution Medicines Reports Q3 2025 Financial Results and Clinical Progress

RVMD

Earnings

Guidance Update

New Projects/Investments

Revolution Medicines reported a net loss of $305.2 million for the quarter ended September 30, 2025, and reiterated its full-year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion. The company's cash, cash equivalents, and marketable securities stood at $1.93 billion as of September 30, 2025.
The company is winding down global enrollment for the RASolute 302 clinical trial studying daraxonrasib in patients with previously treated PDAC, with data readout anticipated in 2026.
Revolution Medicines has initiated RASolute 304, a Phase 3 clinical trial of daraxonrasib for adjuvant treatment in resectable PDAC, and remains on track to initiate RASolute 303 for patients with first-line metastatic PDAC this year.
Daraxonrasib has received FDA Breakthrough Therapy Designation, Orphan Drug Designation, and a Commissioner’s National Priority Voucher.
The company also made new leadership appointments to strengthen global development and commercialization capabilities.

Nov 5, 2025, 9:00 PM

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