How might multi-selective RAS inhibitors (daraxonrasib, RM-055) be positioned in first-line NSCLC, given the company's multiple mutant-selective inhibitors?

All possibilities are still on the table, as the company intentionally pursued both multi-selective and mutant-selective inhibitors to create maximum optionality for patients. It is premature to make exclusive commitments, and multiple regimens might be complementary, so the company will continue to pursue them. “We've intentionally pursued both the multi-selective as well as the mutant selective inhibitors to create the most optionality for us and then ultimately for patients. And I think all of this will play out over time.”

Any early feedback on daraxonrasib's performance in the EAP relative to clinical trials? What are the regulatory timelines in Europe given the phase review process?

EAP feedback is qualitative and anecdotal, not quantitative, as it is a clinical access program, not a trial. Institutions are enthusiastic, and patients are encouraged. EMA timelines are unclear, as the 'phase review' is intended for expedited review, but the actual meaning and duration are up to the EMA. “The EMA made it clear that the phase review is intended to be an expedited review process. What that actually ends up meaning really is a question for the EMA, and we'll just support it as well as we can.”

How will crossover of control arm patients to commercial daraxonrasib impact OS/PFS in frontline PDAC studies? Will EAP patients convert to commercial patients upon approval?

Crossover could affect overall survival analysis but not progression-free survival. The company is thoughtfully activating sites geographically and working with investigators to ensure trial integrity. EAP patients will transition to commercial supply with support services to minimize interruptions, with most expected to transition within a few months. “Once an approval occurs, our patient support services team will work very closely with treating physicians and health care providers. And the intention here, of course, is to help minimize treatment interruptions, provide seamless transition of care over to commercial supply.”

RVMD

Revolution Medicines (RVMD) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 5, 2026

Source: earnings call transcript

Executive summary

Revolution Medicines Q2 FY26 — Daraxonrasib NDA Accepted, Strong Pipeline Progress in Pancreatic and Lung Cancers

Revolution Medicines reported a transformational quarter, marked by the FDA's acceptance of daraxonrasib's NDA for pancreatic cancer and significant progress in its expanded access program. The company also showcased compelling clinical data for its RAS(ON) inhibitors in both pancreatic and non-small cell lung cancers, reinforcing its broad pipeline strategy. Despite increased operating expenses and net loss driven by accelerated development and commercialization efforts, the company maintains a strong financial position to advance its mission in RAS-addicted cancers.

Highlights

Daraxonrasib's New Drug Application (NDA) for pancreatic cancer was accepted for review by the U.S. FDA.
The European Medicines Agency (EMA) designated daraxonrasib as a high priority under its Cancer Medicines Pathfinder project, initiating a phase review.
The Expanded Access Program (EAP) for daraxonrasib has provided the drug to greater than 2,000 eligible patients across the U.S.
Zoldonrasib combined with standard of care chemotherapy showed compelling preliminary objective response rates of 82% and 61% in first-line RAS G12D pancreatic cancer.
Elironrasib in combination with pembrolizumab and chemotherapy demonstrated a highly encouraging objective response rate of 85% in first-line RAS G12C non-small cell lung cancer.

Concerns

Net loss for Q2 FY26 increased to $644 million, compared to $248 million for Q2 FY25.
Full-year 2026 GAAP operating expense expectations were updated to between $2.1 billion and $2.2 billion, reflecting increased investment.
A noncash charge of $151 million was incurred in Q2 FY26 related to a change in the fair value of warrants assumed from the EQRx acquisition.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year 2026 GAAP operating expenses	$2.1 billion to $2.2 billion high materiality	FY26	High
Full-year 2026 noncash stock-based compensation expense	$270 million to $290 million medium materiality	FY26	High
RASolve 301 initial readout	2027 high materiality	CY27	High
RMC-5127 recommended Phase II dose identification	second half of this year medium materiality	H2 2026	High
RMC-5127 initial clinical data	2027 medium materiality	CY27	High
RM-055 first-in-human study initiation	fourth quarter medium materiality	Q4 · FY26	High
RASolve 307 initiation	fourth quarter of 2026 high materiality	Q4 · FY26	High
Colorectal cancer data update and development plans	fourth quarter of this year medium materiality	Q4 · FY26	High

Deals & partnerships

Royalty Pharma Funding arrangement $250 million

Received the second royalty tranche as part of a broader funding arrangement.

Tango Therapeutics Clinical collaboration for MTA-cooperative PRMT5 inhibitors

Evaluating RAS(ON) inhibitors in combination with MTA-cooperative PRMT5 inhibitors.

Bristol Myers Squibb Clinical collaboration for MTA-cooperative PRMT5 inhibitors

Evaluating RAS(ON) inhibitors in combination with MTA-cooperative PRMT5 inhibitors.

Summit Therapeutics Clinical collaboration for daraxonrasib in combination with ivonescimab

Evaluating daraxonrasib in combination with Summit's PD-1 VEGF bispecific antibody and platinum doublet therapy in first-line non-small cell lung cancer.

Risks & headwinds

Increased operating expenses FY26

Full-year 2026 GAAP operating expenses expected to be $2.1 billion to $2.2 billion

Mitigation:Strategic investment to accelerate manufacturing, clinical development, and commercial readiness for potential launches.

Net loss increase Q2 FY26

Net loss of $644 million for Q2 FY26

Mitigation:Driven by higher operating expenses and a noncash charge related to warrants; company maintains strong financial position.

Clinical trial crossover risk Ongoing for RASolute 303

Potential for patients in control arms of frontline PDAC studies to access commercial daraxonrasib

Mitigation:Thoughtful geographic activation of trial sites and working with investigators to ensure trial integrity and minimize impact on overall survival analysis.

What to watch in Q3 FY26

Colorectal Cancer Development Strategy

Q4 2026

Current Discussion of development plans expected

Target Clear registrational path in CRC

Why it matters

Provides clarity on the company's strategy and potential for a new indication, impacting future growth drivers.

In colorectal cancer, we look forward to providing a data update and visibility into our development plans during the fourth quarter of this year.

Find out whether RVMD delivers this. Inve re-checks your case every morning.

Q&A highlights

What does proof-of-concept look like for CRC given prior failures? How will elironrasib compete with second-gen G12C inhibitors in first-line NSCLC?

The CRC question was deferred to a later time when more concrete plans and data can be shared. For elironrasib, management believes it has a highly competitive safety and efficacy profile, supported by monotherapy and combination data, and the company's broad portfolio targets over 70% of RAS mutations in NSCLC.

“We believe that elironrasib has a very good profile, both safety and efficacy. And we're always data-driven in terms of our decision-making. And we felt that it was important to have a robust data set available in order to make this important decision.”

asked by Marc Frahm · answered by Alan Bart Sandler

2 min read 7 chapters

Detailed narrative

Daraxonrasib in Pancreatic Cancer

Revolution Medicines highlighted the transformational impact of daraxonrasib, with its New Drug Application accepted by the FDA following compelling Phase III RASolute 302 results. The EMA also recognized daraxonrasib as a high priority, initiating a phase review to accelerate assessment. The company is actively preparing for a successful launch, having established commercial infrastructure and an expanded access program to serve patients quickly and broadly.

Expanded Access Program (EAP) Success

The FDA-cleared Expanded Access Program for daraxonrasib has seen significant progress, activating sites in almost all 50 U.S. states and Puerto Rico. The company has approved over 90% of reviewed requests, providing daraxonrasib to more than 2,000 eligible patients. This rapid uptake underscores the high unmet need and interest in daraxonrasib for previously treated metastatic pancreatic cancer.

Pancreatic Cancer Pipeline Expansion

Beyond previously treated disease, Revolution Medicines is prosecuting a comprehensive development strategy in pancreatic cancer. Enrollment continues in Phase III RASolute 303 (first-line metastatic) and 304 (adjuvant) for daraxonrasib, and RASolute 305 (first-line metastatic) for zoldonrasib. The company also initiated RASolute 309, evaluating the novel doublet of daraxonrasib plus zoldonrasib in the first-line setting, reflecting a broad portfolio approach.

Zoldonrasib and Daraxonrasib Doublet Data in PDAC

New data presented at ESMO GI reinforced zoldonrasib's compelling profile. In first-line RAS G12D pancreatic cancer, zoldonrasib combined with FOLFIRINOX or gemcitabine plus nab-paclitaxel showed objective response rates of 82% and 61%, respectively. The daraxonrasib plus zoldonrasib doublet demonstrated preliminary clinical activity in second and third-line RAS G12D PDAC, with objective response rates of 50% and 47%, and median progression-free survival of 9.6 months and 7.6 months, respectively.

NSCLC Pipeline and Strategy

Non-small cell lung cancer represents another major opportunity, with RAS mutations present in approximately 30% of patients. Daraxonrasib received Breakthrough Therapy Designation for previously treated metastatic NSCLC with KRAS mutations other than G12C. The company's mutant-selective inhibitors (elironrasib, zoldonrasib, RMC-5127) have the potential to address over 70% of RAS-driven mutations in this disease, positioning Revolution Medicines uniquely to meet significant unmet needs.

Zoldonrasib and Elironrasib in First-Line NSCLC

Highly encouraging antitumor activity was observed for zoldonrasib and elironrasib in combination with pembrolizumab and chemotherapy in first-line NSCLC. Zoldonrasib achieved an 82% objective response rate and 100% disease control rate in KRAS G12D NSCLC. Elironrasib demonstrated an 85% objective response rate, 97% disease control rate, and 95% six-month progression-free survival rate in RAS G12C NSCLC, supporting their advancement into registrational development.

Financial Position and Investment Strategy

The company ended Q2 2026 with a strong cash and investments balance of $3.9 billion, including proceeds from recent public offerings and a royalty tranche. This financial strength supports an increased investment strategy, with full-year GAAP operating expenses now projected between $2.1 billion and $2.2 billion. This investment is driven by accelerated manufacturing, clinical development across multiple programs, and expanded commercial readiness efforts globally.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.