Revolution Medicines za poslední měsíc přidala asi 6,6 %, ale ve 2. čtvrtletí roku 2026 vykázala vyšší než očekávanou upravenou ztrátu 2,34 USD na akcii a nulové výnosy.
A month has gone by since the last earnings report for Revolution Medicines, Inc. (RVMD - Free Report) . Shares have added about 6.6% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Revolution Medicines due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.
Q2 Loss Wider Than Expected, Sales NilRevolution Medicines reported an adjusted loss of $2.34 per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of $1.93.
The adjusted figure excluded a non-cash charge of $151 million tied to a change in the fair value of warrants assumed through the EQRx acquisition, which closed in 2023. Including this item, the reported loss was $3.06 per share. The company had incurred a loss of $1.31 per share in the year-ago quarter.
Currently, the company does not have any approved product in its portfolio. It generated no revenues in the quarter.
Operating Expenses See a Significant IncreaseResearch and development expenses surged 76% year over year to around $395 million. The increase reflected higher costs associated with clinical studies and manufacturing for the company’s pipeline candidates, along with increased employee-related expenses.
General and administrative expenses increased nearly 172% to more than $110 million. The increase was caused by higher personnel and stock-based compensation costs, increased commercial preparation activities and elevated administrative expenses.
2026 Expense Outlook Moves Higher AgainThe company revised its operating expenses guidance for the second time this year. It expects the figure to be between $2.1 billion and $2.2 billion, up from the previous projection of $1.7 billion to $1.8 billion.
The updated forecast includes expected non-cash stock-based compensation expenses of $270 million to $290 million compared with the prior estimate of $260 million to $280 million.
Management intends to increase spending on commercial and clinical manufacturing, expand the company’s development programs and strengthen launch readiness in the United States and international markets.
Improved Cash PositionThe company ended June with cash, cash equivalents and marketable securities of $3.9 billion, up from $1.9 billion as of March 31, 2026.
The increase was primarily driven by $2.225 billion in gross proceeds from concurrent offerings of common stock and convertible senior notes completed in April 2026. The quarter-end balance also included a $250 million payment received from Royalty Pharma in May.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates revision.
The consensus estimate has shifted -19.12% due to these changes.
VGM ScoresAt this time, Revolution Medicines has a poor Growth Score of F, however its Momentum Score is doing a bit better with a D. Charting a somewhat similar path, the stock was allocated a score of F on the value side, putting it in the bottom 20% quintile for value investors.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Revolution Medicines has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Performance of an Industry PlayerRevolution Medicines is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Agios Pharmaceuticals (AGIO - Free Report) , a stock from the same industry, has gained 3.7%. The company reported its results for the quarter ended June 2026 more than a month ago.
Agios Pharmaceuticals reported revenues of $44.74 million in the last reported quarter, representing a year-over-year change of +259.4%. EPS of -$1.69 for the same period compares with -$1.93 a year ago.
Agios Pharmaceuticals is expected to post a loss of $1.32 per share for the current quarter, representing a year-over-year change of +25.8%. Over the last 30 days, the Zacks Consensus Estimate has changed +10.4%.
The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Agios Pharmaceuticals. Also, the stock has a VGM Score of F.
FDA schválila RASONQUE od Revolution Medicines pro metastatický pankreatický adenokarcinom. Akcie po oznámení téměř nereagovaly, protože dobré zprávy byly už započtené v ceně.
Revolution Medicines NASDAQ: RVMD just landed one of the biggest wins in oncology this year, and the stock barely blinked. On Aug. 26, the FDA approved RASONQUE (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer.
Revolution Medicines Today
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In the pivotal RASolute 302 trial, patients on RASONQUE nearly doubled their median overall survival compared to standard chemotherapy.
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This is a genuinely rare outcome in a disease that has resisted targeted therapy for decades.
By any normal standard, that's the kind of headline that sends a biotech stock soaring. Instead, RVMD shares traded roughly flat on the day of approval. The reason is simple: investors had already bought the rumor.
RASolute 302's data was presented at oncology conferences months earlier, and the stock rallied 41% in a single day.
That gap between medical significance and market reaction is the real story here. It's also a lesson in how markets price information, not just outcomes.
The Science Is the Easy Part to BelieveRAS mutations drive more than 90% of pancreatic cancer cases, and for decades, RAS was considered "undruggable." Revolution Medicines built its entire platform around cracking that problem with its RAS(ON) tri-complex inhibitor technology, which binds the active, "on" state of the RAS protein rather than the inactive state that most earlier compounds targeted.
RASONQUE's approved label reflects just how far that platform has come. The drug is cleared for adults with metastatic pancreatic adenocarcinoma who've had at least one prior therapy, with or without an identified RAS mutation, and without requiring a companion diagnostic test.
That's a notably broad population for a targeted therapy. It's also a meaningful part of why oncologists are calling this a paradigm shift rather than an incremental improvement.
Priced in, Then Priced... Where, Exactly?Here's where the RVMD story gets more interesting than a simple "sell the news" narrative. Looking at the daily chart, RVMD isn't crashing; it's consolidating near all-time highs after an extraordinary run.
Shares recently traded around $210; down about 2% since the Aug. 26 announcement, but that's a rounding error against a stock that's up over 425% over the past 12 months and still trading near its 52-week high of $224.31. The 50-day moving average continues sloping upward, and MACD remains in bullish territory. It's what's known as a beautiful chart.
Analyst behavior tells a similar story. Since the approval, the Revolution Medicines analyst forecasts on MarketBeat show multiple firms have raised price targets, with Evercore having the most bullish target of $320. That kind of response shows that analysts had already modeled approval into estimates and are now recalibrating around what comes next: first-line expansion, additional tumor types, and peak sales assumptions.
The Competitive Picture Favors RVMD—For NowEli Lilly NYSE: LLY is often cited as RVMD's biggest threat in the RAS space, and it's a legitimate long-term competitor. But the comparison requires some precision. Lilly's lead RAS asset, olomorasib, is still in Phase 3 trials and targets only KRAS G12C-mutated tumors — a single mutation subtype. It isn't yet approved for pancreatic cancer at all.
RASONQUE, by contrast, launched with an approved label covering the broader RAS-mutant population, no diagnostic test required. Lilly does have earlier-stage G12D and pan-KRAS programs in development, along with rivals like Amgen NASDAQ: AMGN, Roche OTCMKTS: RHHBY, Merck NYSE: MRK, and Boehringer Ingelheim, all advancing their own RAS-pathway candidates.
The competitive field is real and will intensify. Today, though, Revolution Medicines holds the only broadly approved RAS-targeted therapy in pancreatic cancer, and that head start matters for capturing first-mover share in prescribing patterns.
The Bill for Building a Commercial BiotechThe one note of caution sits in the financials, not the clinical data. Revolution Medicines raised its 2026 GAAP operating expense guidance to a range of $2.1 billion to $2.2 billion as it scales manufacturing, clinical development, and commercial infrastructure simultaneously. Second-quarter net loss widened sharply to $644 million, up from $248 million a year earlier.
That's the cost of transitioning from a clinical-stage biotech to a commercial oncology company in real time. Furthermore, that kind of spending is not unusual for a first launch of this scale.
But it's worth noting that RASONQUE is currently doing the heavy lifting alone. The company's broader pipeline—additional RAS(ON) candidates across lung and colorectal cancer—is expanding, but nothing else appears close to its own approval in the near term. Investors betting on RVMD from here are effectively betting on one drug's commercial execution and label expansion, not a diversified product portfolio.
What Actually Moves This Stock From HereWith approval priced in and the "will it work" question answered, the next re-rating catalysts are execution-based rather than binary: first-line treatment expansion, additional trial readouts in lung and colorectal cancer, insurance reimbursement uptake at RASONQUE's $39,800 monthly list price, and evidence that the company can control spend as it scales commercially.
The medicine itself is a legitimate breakthrough for a disease for which patients have received almost nothing for decades. The stock's next move depends on something less dramatic: whether Revolution Medicines can turn a scientific win into a commercial one before cash burn outruns the launch.
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FDA schválila lék Rasonque společnosti Revolution Medicines na metastatický karcinom slinivky po předchozí léčbě nebo při nemožnosti kombinované chemoterapie. V testu zdvojnásobil přežití pacientů s pokročilým onemocněním.
The U.S. FDA has approved Revolution Medicines' (RVMD.O) groundbreaking pancreatic cancer drug after it was shown to double the survival rate of patients with advanced disease in a large trial, offering new hope to those with the deadly cancer.
The once-daily pill, to be called Rasonque, was approved for metastatic pancreatic cancer in patients who have received prior treatment or cannot receive combination chemotherapy. The drug is designed to block several forms of the RAS protein, which helps drive tumor growth in many pancreatic cancers.
Revolution said the drug is now available in the United States at $39,800 for a 30-day supply. The company added that it would make assistance available as well.
When Revolution announced the trial results in April for the drug, it set off a firestorm of demand. The FDA quickly granted early access to it under its compassionate use program, which allows patients with serious or life-threatening conditions to get experimental treatments outside clinical trials prior to authorization by the regulator.
The treatment has already offered some patients with early access to the drug a reprieve from the toll of chemotherapy.
Barbara Andes, 88, of Fullerton, California, who began taking it in July after a year of chemotherapy, said the pill allowed her to resume regular activities and caused far less nausea and fatigue.
"It's going to open this door now commercially for so many, many more people who are suffering," Andes said. "It's a godsend."
SPEEDY REVIEW
The drug was part of the Food and Drug Administration's new expedited review process, designed to shrink timelines to as little as one to two months from the usual 10 to 12.
"This approval validates more than a decade of work aimed at pancreatic cancer, primarily RAS-driven disease, and one of the most difficult challenges in medicine, cancer biology, and drug discovery," Revolution CEO Mark Goldsmith said.
Investors have flocked to Revolution on expectations that Rasonque could become a major new treatment option, driving the company's stock up 166% this year. Its approval was widely expected and Revolution shares were relatively flat at $211.70.
RBC Capital Markets analysts said the rapid approval, along with more than 2,000 patients already enrolled in the Expanded Access Program, could help drive an estimated $28 million in U.S. pancreatic cancer revenue in the third quarter. Fourth-quarter sales could reach $148 million.
Longer term, the analysts estimated the drug could generate $11.5 billion in annual global sales. The American Cancer Society estimates about 67,350 patients to be diagnosed with pancreatic cancer this year.
DOCTORS HAIL BREAKTHROUGH
Doctors expect Rasonque to transform how they tackle a disease that has been very difficult to treat.
"This is just the tip of the iceberg in terms of what we're going to see in terms of targeting the RAS pathway for pancreas cancer," said Rachna Shroff, chief of hematology and oncology at the University of Arizona Cancer Center.
"Not only did people live longer, but their quality of life improved," Shroff said, noting that patients stayed on the drug longer than they did on chemotherapy.
Peter Hosein, associate director for clinical research at the Pancreatic Cancer Research Institute at Sylvester Comprehensive Cancer Center, described it as a paradigm shift.
"Researchers have been trying to make a breakthrough in RAS inhibition for decades and, due to unrelenting persistence, this breakthrough is finally here," he said.
Revolution Medicines ve 2. čtvrtletí vykázala upravenou ztrátu 2,34 USD na akcii, vyšší, než čekal trh, a podruhé letos zvýšila výhled provozních nákladů na rok 2026 na 2,1 až 2,2 mld. USD.
Key Takeaways RVMD reported a Q2 adjusted loss of $2.34 per share, wider than expectations.Revolution Medicines raised its 2026 operating expense outlook for the second time this year.RVMD advanced daraxonrasib and other RAS-targeted programs in late-stage development. Revolution Medicines (RVMD - Free Report) reported an adjusted loss of $2.34 per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of $1.93.
The adjusted figure excluded a non-cash charge of $151 million tied to a change in the fair value of warrants assumed through the EQRx acquisition, which closed in 2023. Including this item, the reported loss was $3.06 per share. The company had incurred a loss of $1.31 per share in the year-ago quarter.
Currently, RVMD does not have any approved products in its portfolio. It has yet to generate revenues.
Shares of the company fell in after-market trading yesterday as investors did not react favorably to the wider-than-expected loss. The decline also reflected concerns over management’s decision to raise its operating expense guidance for the second time this year.
The stock has skyrocketed 148% year to date compared with the industry’s nearly 3% growth.
Image Source: Zacks Investment Research
RVMD’s Operating Expenses Increase SharplyResearch and development expenses surged 76% year over year to around $395 million. The increase reflected higher costs associated with clinical studies and manufacturing for the company’s pipeline candidates, along with increased employee-related expenses.
General and administrative expenses increased nearly 172% to more than $110 million. The increase was driven by higher personnel and stock-based compensation costs, increased commercial preparation activities and elevated administrative expenses.
Revolution Medicines Raises 2026 Expense View AgainThe company revised its operating expenses guidance for the second time this year. It expects the figure to be between $2.1 billion and $2.2 billion, up from the previous projection of $1.7 billion to $1.8 billion.
The updated forecast includes expected non-cash stock-based compensation expenses of $270 million to $290 million compared with the prior estimate of $260 million to $280 million.
Management intends to increase spending on commercial and clinical manufacturing, expand the company’s development programs and strengthen launch readiness in the United States and international markets.
RVMD Strengthens Cash PositionThe company ended June with cash, cash equivalents and marketable securities of $3.9 billion, up from $1.9 billion as of March 31, 2026.
The increase was primarily driven by $2.225 billion in gross proceeds from concurrent offerings of common stock and convertible senior notes completed in April. The quarter-end balance also included a $250 million payment received from Royalty Pharma in May.
Revolution Medicines Advances Daraxonrasib in Pancreatic CancerLast month, Revolution Medicines announced that the FDA accepted a regulatory filing for its lead candidate, daraxonrasib, in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The filing is supported by data from the phase III RASolute 302 study, which showed statistically significant improvements in overall survival, progression-free survival and patient-reported quality of life versus chemotherapy.
The submission is being reviewed under the agency’s Commissioner’s National Priority Voucher (“CNPV”) pilot program, which significantly cuts down the review period to just one to two months. Revolution Medicines said its U.S. commercial infrastructure is ready to support a potential launch, including its sales organization, patient services platform, field access team and distribution network. The EMA also initiated a phased review under its Cancer Medicines Pathfinder project.
In the meantime, Revolution Medicines is evaluating daraxonrasib in two phase III studies — RASolute 303 and RASolute 304 — across earlier lines of treatment for PDAC. While RASolute 303 is assessing the drug in the first-line metastatic setting, RASolute 304 is evaluating its efficacy in the adjuvant setting.
Beyond PDAC, the company is also conducting the late-stage RASolve 301 study of daraxonrasib in patients with previously treated RAS-mutant non-small cell lung cancer (NSCLC). It expects to complete enrollment this year, supporting an initial readout in 2027.
RVMD Progresses Other Pipeline DrugsAlongside the earnings results, RVMD reported initial clinical data (as of the data cut-off of May 11, 2027) from separate studies on mutant-selective inhibitors, including elironrasib, which targets G12C, and zoldonrasib, which targets G12D.
Zoldonrasib combined with Merck’s (MRK - Free Report) Keytruda and platinum doublet chemotherapy produced an overall response rate (ORR) of 82% and a disease control rate (DCR) of 100% in evaluable patients with first-line RAS G12D NSCLC. Median follow-up was 3.4 months. Based on these results, the company recently started the phase III RASolve 308 study of this combination.
The elironrasib plus Keytruda and platinum doublet chemotherapy combination generated a confirmed ORR of 85% and a DCR of 97% in first-line RAS G12C NSCLC. At 8.7 months of median follow-up, 95% of patients remained progression-free at six months. Based on these findings, RVMD intends to start the phase III RASolve 307 study in the fourth quarter of 2026.
The company also announced that it recently started the phase III RASolute 309 study to evaluate the combination of zoldonrasib and daraxonrasib in previously treated RAS G12D PDAC. This initiation was supported by data from a phase I/II study, which showed that the regimen demonstrated compelling preliminary antitumor activity with a manageable safety and tolerability profile.
To further strengthen its position in the RAS-addicted cancer space, Revolution Medicines has entered into several agreements to accelerate the development of its pipeline. The company has established clinical collaborations with Bristol Myers (BMY - Free Report) , Summit Therapeutics (SMMT - Free Report) and Tango Therapeutics to evaluate combinations of its RAS inhibitors with their respective pipeline drugs.
RVMD’s Zacks RankThe stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Revolution Medicines oznámila, že FDA přijala k přezkumu její žádost o registraci daraxonrasibu pro dříve léčený metastatický karcinom pankreatu. Společnost zároveň uvedla, že její čistá ztráta ve 2. čtvrtletí vzrostla na 644 milionů USD.
Revolution Medicines NASDAQ: RVMD said its second-quarter 2026 results reflected continued investment in late-stage cancer programs, commercial launch preparations and manufacturing capacity as it advances daraxonrasib and other RAS-targeted therapies across pancreatic and lung cancer.
The company ended the quarter with $3.9 billion in cash and investments, including proceeds from April offerings of common stock and convertible notes that generated $2.2 billion in gross proceeds, as well as a $250 million second royalty tranche from Royalty Pharma. Revolution Medicines said up to an additional $1.5 billion remains available under that funding arrangement if specified milestones are achieved.
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Net loss for the quarter ended June 30 widened to $644 million from $248 million a year earlier. The quarterly loss included a $151 million non-cash charge related to the increased fair value of warrants assumed in the EQRx acquisition, driven by an increase in Revolution Medicines’ stock price.
Daraxonrasib regulatory and access progress Chairman and Chief Executive Officer Mark Goldsmith said the company’s new drug application for daraxonrasib in previously treated metastatic pancreatic cancer has been accepted for review by the U.S. Food and Drug Administration. The application is supported by the completed Phase III RASolute 302 study, whose results were presented at the American Society of Clinical Oncology meeting and published in the New England Journal of Medicine.
Goldsmith said RASolute 302 showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival and patient-reported quality-of-life measures for daraxonrasib monotherapy compared with chemotherapy, with what the company described as a manageable safety and tolerability profile.
Revolution Medicines has also established an FDA-cleared expanded access program for eligible U.S. patients. Goldsmith said the program has activated sites in nearly all 50 states and Puerto Rico, spanning academic cancer centers and community oncology practices. The company has approved more than 90% of reviewed requests and provided daraxonrasib on behalf of more than 2,000 eligible patients.
In Europe, the European Medicines Agency has designated daraxonrasib as a high priority under its Cancer Medicines Pathfinder and started a phased review intended to accelerate assessment ahead of a full marketing authorization application. Goldsmith said the company is continuing discussions with the EMA and other regulatory authorities.
The company said its U.S. commercial infrastructure is in place for a potential launch, including a sales organization, field access team, patient services program, commercial supply and distribution network. Anthony Mancini, chief global commercialization officer, said the sales organization includes about 60 individuals and is designed to support a pancreatic cancer launch while broader commercialization infrastructure could support future indications.
Pancreatic cancer pipeline expands Revolution Medicines continues to enroll patients in the Phase III RASolute 303 study in first-line metastatic pancreatic cancer and RASolute 304 study in the adjuvant setting, both involving daraxonrasib. The company is also enrolling patients in RASolute 305, a Phase III study of zoldonrasib plus chemotherapy in first-line metastatic pancreatic cancer with RAS G12D mutations.
The company recently initiated RASolute 309, a Phase III study evaluating the combination of daraxonrasib and zoldonrasib in the first-line RAS G12D pancreatic cancer setting.
At the European Society for Medical Oncology Gastrointestinal Cancers Congress, Revolution Medicines reported preliminary data for zoldonrasib combined with chemotherapy in first-line RAS G12D pancreatic cancer. The company reported objective response rates of 82% with modified FOLFIRINOX and 61% with gemcitabine plus nab-paclitaxel, with disease control rates of 96% and 90%, respectively. It said longer follow-up is needed to assess durability.
In another study, the daraxonrasib-zoldonrasib doublet produced objective response rates of 50% in second-line patients and 47% in patients treated in the third line or later, according to the company. Median progression-free survival was 9.6 months in the second-line group and 7.6 months in the later-line group. Median overall survival had not been reached in the second-line setting, while it was 10.5 months in the third-line-or-later group.
Lung cancer programs move toward registrational studies Chief Development Officer Alan Sandler said the company is advancing mutant-selective RAS(ON) inhibitors in first-line non-small cell lung cancer. The FDA has granted breakthrough therapy designation to daraxonrasib for previously treated metastatic non-small cell lung cancer with KRAS mutations other than G12C in patients who previously received platinum chemotherapy and PD-1 or PD-L1 therapy.
Revolution Medicines expects to complete enrollment in its Phase III RASolve 301 study of daraxonrasib in previously treated RAS-mutant non-small cell lung cancer this year, supporting an initial readout in 2027.
The company also disclosed early combination data for zoldonrasib and elironrasib with pembrolizumab and platinum-based chemotherapy in previously untreated non-small cell lung cancer. In KRAS G12D disease, zoldonrasib’s combination produced an 82% objective response rate and disease control in all evaluable patients after a median 3.4 months of follow-up as of May 11.
For elironrasib in RAS G12C non-small cell lung cancer, the company reported an 85% confirmed objective response rate, a 97% disease control rate and a 95% progression-free survival rate at six months, based on median follow-up of 8.7 months. Sandler said safety findings for both regimens were broadly consistent with pembrolizumab-based chemotherapy, with no new or unexpected safety signals reported for zoldonrasib.
Revolution Medicines has initiated RASolve 308, a randomized placebo-controlled study of zoldonrasib plus pembrolizumab and platinum-doublet chemotherapy in RAS G12D non-small cell lung cancer. It expects to begin RASolve 307, a similar study of elironrasib in RAS G12C disease, in the fourth quarter of 2026.
Expenses and outlook Research and development expense increased to $395 million from $224 million a year earlier, primarily reflecting higher clinical trial and manufacturing costs for daraxonrasib and zoldonrasib, additional personnel and stock-based compensation. General and administrative expense rose to $110 million from $41 million, driven by headcount, commercialization preparations and administrative costs.
The company increased its full-year 2026 GAAP operating expense forecast to between $2.1 billion and $2.2 billion, including expected non-cash stock-based compensation of $270 million to $290 million. Chief Financial Officer Jack Anders said the higher outlook reflects accelerated manufacturing for clinical and potential commercial supply, expanded clinical development activity and increased U.S. and international commercialization investments.
Goldsmith said Revolution Medicines plans to provide a colorectal cancer data update and outline its development plans in the fourth quarter. The company also expects to identify a recommended Phase II dose for RMC-5127 in the second half of 2026 and initiate a first-in-human study of RM-055 in the fourth quarter.
About Revolution Medicines (NASDAQ:RVMD)Revolution Medicines is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapies to treat RAS-dependent cancers and other diseases driven by the RAS/MAPK pathway. The company's research efforts target historically “undruggable” proteins, aiming to inhibit critical nodes in cell signaling that promote tumor growth and therapeutic resistance.
The lead pipeline includes RMC-4630, a SHP2 inhibitor; RMC-6291, a selective KRAS G12C inhibitor; and RMC-6236, a pan-RAS inhibitor designed to address multiple RAS mutations.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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FDA přijala k přezkumu žádost Revolution Medicines o schválení daraxonrasibu pro dříve léčený metastatický karcinom pankreatu. Žádost stojí na výsledcích fáze 3 RASolute 302.
REDWOOD CITY, Calif., July 22, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
“The FDA’s acceptance of the daraxonrasib NDA is an important step in the regulatory review process and brings us closer to the possibility of offering patients a new targeted medicine for previously treated metastatic pancreatic cancer,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Daraxonrasib is an oral targeted medicine designed to inhibit RAS, the main cause of pancreatic cancer, and the application is supported by unprecedented results from the Phase 3 RASolute 302 trial. These findings underscore the potential for daraxonrasib to become a new standard of care and to help define a new class of RAS‑targeted medicines for this disease. We look forward to continuing to work closely with the FDA as the agency reviews the application, and with other global regulatory authorities as we advance our efforts to bring daraxonrasib to patients as quickly as possible.”
The NDA is based on results from the global, randomized Phase 3 RASolute 302 trial, evaluating daraxonrasib versus standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. The trial met all primary and key secondary endpoints, including unprecedented improvements in overall survival and progression-free survival. In addition, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy. Results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine.
Daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities. The FDA previously granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic PDAC.
The Company recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has begun a phased review of daraxonrasib, allowing data to be evaluated as they become available before submission of a full marketing authorization application. Daraxonrasib has also received orphan medicine designation for the treatment of pancreatic cancer, and high-priority status under EMA’s Cancer Medicines Pathfinder project based on its potential to address a significant unmet need.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1 Due to the lack of early symptoms and detection methods, most patients are diagnosed with pancreatic ductal adenocarcinoma (PDAC) at an advanced or metastatic stage. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.2,3
About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, noncovalent tri-complex inhibitor that works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. It is designed to target cancers driven by a broad range of common RAS genotypes, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC.
About the RASolute 302 Clinical Trial
RASolute 302 (NCT06625320) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator’s choice of four different cytotoxic chemotherapy regimens, which represent standard of care across the globe. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type).
The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.
About Revolution Medicines, Inc.
Revolution Medicines is a company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the broad potential of RAS(ON) inhibition and the potential for a new class of RAS-targeted therapy to emerge; treatment practices for pancreatic cancer and the potential for daraxonrasib to become a standard of care; the company’s regulatory interactions; the company’s ability to bring daraxonrasib to patients; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied.
Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 6, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
References
1 Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
2 Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges. Cell. 2023;186(8):1729-1754. doi:10.1016/j.cell.2023.02.014
3 American Cancer Society. Survival Rates for Pancreatic Cancer. Available at: https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html. Accessed July 2026.
EMA zahájila průběžný přezkum daraxonrasibu od Revolution Medicines, aby urychlila posouzení léku na rakovinu slinivky břišní. Firma zároveň dokončuje podání NDA u FDA.
Phased review by EMA aims to accelerate assessment of company's investigational drug daraxonrasib in pancreatic cancer based on unprecedented clinical results from pivotal Phase 3 RASolute 302 trial
Rolling submission of NDA for daraxonrasib to U.S. FDA under Commissioner’s National Priority Voucher pilot program nearing completion
REDWOOD CITY, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a phased review of data on daraxonrasib, the company's investigational RAS(ON) multi-selective inhibitor. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases as they become available, ahead of the submission of a full marketing authorization application. Daraxonrasib was designated by the EMA as an orphan medicinal product for the treatment of pancreatic cancer and has been recognized as a high priority under EMA’s Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need.
In addition, the company continues to make significant progress on its rolling submission of a New Drug Application (NDA) for daraxonrasib to the U.S. Food and Drug Administration (FDA) under the Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
“As our rolling submission of an NDA to the FDA nears completion, we are encouraged by the strong engagement we've received from health authorities around the world,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “The EMA's decision to include daraxonrasib in its new phased review process is an important step toward making this medicine available to patients globally as quickly as possible. We believe this milestone underscores both the significant unmet medical need in pancreatic cancer and the potential of daraxonrasib to address that need.”
The company continues to engage in discussions with regulatory authorities around the world as it prepares for submissions in additional territories. The ongoing FDA review and planned regulatory submissions in other territories are supported by the positive results from the pivotal Phase 3 RASolute 302 trial, which demonstrated unprecedented improvements in overall survival and progression-free survival compared to standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. In the trial, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy.
About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent tri-complex inhibitor. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC.
Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. Pancreatic ductal adenocarcinoma, or PDAC, is the most common form of pancreatic cancer.1
Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. PDAC is the most commonly RAS-driven malignancy of all major cancers, with more than 90% of patients having tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.3, 4
About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; the company’s regulatory strategy and the timing, status and progress of any regulatory submissions; discussions with regulatory agencies including the EMA and FDA; and the potential for daraxonrasib to address unmet medical needs.
Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," “continues,” “intend,” “nears,” "plan," “potential,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 6, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
1 Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
2 Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1);91. doi:10.1038/s41698-022-00334-z.
3 Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges. Cell. 2023;186(8):1729-1754. doi:10.1016/j.cell.2023.02.014
4 American Cancer Society. Survival Rates for Pancreatic Cancer. Available at: https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html. Accessed March 2026.
Revolution Medicines letos vzrostla téměř o 140 % díky pozitivním výsledkům pozdní klinické studie a blíží se podání žádosti o regulační přezkum. Daraxonrasib u metastatického karcinomu slinivky prodloužil přežití na 13,2 měsíce oproti 6,7 měsíce u standardní chemoterapie.
Revolution Medicines (RVMD +0.92%) spent most of its history as a publicly traded company -- that's since 2020 -- trading for less than $50 a share. The company offers a new approach to oncology treatment, aiming for targets once thought to be "undruggable." In recent months, Revolution has clearly demonstrated the potential of its technology and is rapidly approaching the finish line. So, it's no surprise that investors have been taking notice.
In fact, they've taken so much notice that the stock price has soared nearly 140% this year. This is amid positive late-stage clinical trial results and optimism about potential revenue ahead. Considering the full picture and after its triple-digit gain, is this hot biotech stock still a buy? Let's find out.
Image source: Getty Images.
Making the "undruggable" protein "druggable" We'll start off by taking a look at Revolution's technology and pipeline progress. The company focuses on treating cancers linked to the activity of RAS proteins. RAS proteins have generally been called "undruggable" because potential therapeutics can't bind to their surfaces. But Revolution, using its tri-complex inhibitor platform, has found a way, producing "druggable" sites -- the investigational therapeutics then go on to block cancer signaling.
Revolution is exploring its candidates in cancers in which RAS proteins play a key role, and the company recently reported solid results from a phase 3 trial of previously treated metastatic pancreatic cancer. Daraxonrasib delivered a survival rate of 13.2 months versus a survival rate of 6.7 months for patients treated with the standard care of chemotherapy.
The company said these results are considered final, and it's submitting them to support a request for regulatory review. Revolution is also advancing another candidate, zoldonrasib, in phase 3 trials for the same indication.
Revolution has phase 3 trials ongoing for daraxonrasib in non-small cell lung cancer, and zoldonrasib as a combination therapy with standard of care is entering phase 3.
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Results just ahead And the biotech company is conducting earlier-stage trials in colorectal cancer and aims to share results of these combination studies -- with standard of care or investigational approaches -- this year.
Meanwhile, Revolution doesn't yet have products on the market, so it isn't generating revenue -- and due to this period of heavy investment in research and development, the company's loss in the recent quarter doubled from the year-earlier period to more than $453 million. The cash position at $1.9 billion and the $2.1 billion in net proceeds from financing should help support ongoing R&D.
The company clearly has developed an interesting approach to cancer treatment and has made significant progress in pancreatic cancer -- a key area where better treatments are needed. The fact that the company's lead candidate is approaching the finish line is positive, too, as that suggests a revenue stream may be right around the corner. So, if all goes smoothly, Revolution could be very close to becoming a commercial-stage biotech. This could reduce risk as a potential regulatory nod represents a vote of confidence for the technology that's used throughout the pipeline -- and would open the door to revenue and eventually profit.
And speaking of the financial picture, it's not worrisome to see the company's R&D costs climb right now -- this is a standard pattern across biotech companies in the clinical development stage.
Now, let's consider whether the stock is a buy. If you're a cautious investor, it's best to focus on biotech players that already have at least one product on the market and either are profitable or have made steps toward profitability. Biotech companies that aren't yet commercial-stage represent a certain amount of risk.
But, if you're a growth investor who can handle this risk, Revolution, even after its big gain, represents a compelling buy. This is because the company has shown the strength of its technology and may be very close to potential product approval. A regulatory nod and revenue growth to follow could result in significant gains, and Revolution's strong pipeline could lead to more strength down the road. All of this means that, over time, the stock may have plenty of room to run.
Revolution Medicines oznámila, že zoldonrasib v kombinaci s chemoterapií nebo s daraxonrasibem vykázal u metastatického pankreatického duktálního adenokarcinomu (PDAC) s mutací RAS G12D silnou protinádorovou aktivitu a zvládnutelnou bezpečnost.
REDWOOD CITY, Calif., July 02, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced results from two Phase 1/2 clinical trials evaluating zoldonrasib, its oral RAS(ON) G12D-selective covalent inhibitor, in combination regimens for patients with RAS G12D metastatic pancreatic ductal adenocarcinoma (PDAC). The results, which will be presented today in a proffered paper session at the 2026 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress, include zoldonrasib in combination with standard of care chemotherapy in previously untreated patients and zoldonrasib in combination with daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in previously treated patients.
“The Phase 3 RASolute 302 results provided clinical validation of RAS(ON) inhibition with daraxonrasib in second line metastatic pancreatic cancer and established a strong foundation for evaluating this therapeutic approach across additional RAS genotypes, treatment settings and combination strategies. The results presented at ESMO GI demonstrate compelling proof-of-concept for two zoldonrasib-based regimens in RAS G12D disease: combination with standard of care chemotherapy in previously untreated patients and a RAS(ON) inhibitor doublet with daraxonrasib in previously treated patients. Together, these findings are the foundation of two distinct Phase 3 strategies we are pursuing in previously untreated metastatic RAS G12D pancreatic cancer: the ongoing RASolute 305 trial evaluating zoldonrasib plus standard of care chemotherapy, and the planned RASolute 309 trial evaluating the combination of zoldonrasib plus daraxonrasib,” said Alan Sandler, M.D., chief development officer of Revolution Medicines.
Safety and Efficacy of Zoldonrasib Plus Chemotherapy in Patients with First Line RAS G12D Metastatic Pancreatic Cancer (Abstract #340O)
RMC-GI-102 (NCT06445062) is an ongoing Phase 1/2 trial evaluating zoldonrasib 1200 mg once daily in combination with investigator's choice of standard of care chemotherapy in patients with previously untreated metastatic RAS G12D PDAC. Investigator's choice of chemotherapy includes modified FOLFIRINOX (mFFX) or gemcitabine plus nab-paclitaxel (GnP). As of the February 8, 2026 data cutoff, the trial enrolled 41 patients in the zoldonrasib plus mFFX arm and 40 patients in the zoldonrasib plus GnP arm.
Zoldonrasib demonstrated a manageable safety and tolerability profile in combination with standard chemotherapy. The safety profile of zoldonrasib in combination with chemotherapy was broadly consistent with the established profiles of each respective chemotherapy regimen. Grade 3 or greater treatment-related adverse events (TRAEs) occurred in 61% of patients who received the zoldonrasib plus mFFX and 80% of patients who received zoldonrasib plus GnP. The most common Grade 3 or greater TRAEs with zoldonrasib plus mFFX were decreased neutrophil count (37%), anemia (12%), and platelet count decreased (7%). The most common Grade 3 or greater TRAEs with zoldonrasib plus GnP were decreased neutrophil count (35%), anemia (28%), and fatigue (25%). No Grade 5 TRAEs were reported in either arm. The mean dose intensity was 86% with zoldonrasib plus mFFX and 90% with the zoldonrasib plus GnP.
In the trial, zoldonrasib with chemotherapy showed compelling antitumor activity, with an objective response rate (ORR) of 82% (95% confidence interval [CI]: 60, 95) and disease control rate (DCR) of 96% (95% CI: 77, 100) in the mFFX population, and an ORR of 61% (95% CI: 42, 78) and DCR of 90% (95% CI: 74, 98) in the GnP population.
These preliminary safety and clinical activity data support the ongoing RASolute 305 pivotal trial (NCT07621718), a global, randomized, double-blind placebo-controlled Phase 3 clinical trial evaluating zoldonrasib plus investigator’s choice of standard of care chemotherapy compared with placebo plus investigator’s choice of chemotherapy in patients with previously untreated metastatic RAS G12D PDAC.
Safety and Efficacy of Zoldonrasib Plus Daraxonrasib in Patients with Second Line-Plus RAS G12D Metastatic Pancreatic Cancer (Abstract #341O)
RMC-9805-001 (NCT06040541) is a Phase 1 trial evaluating zoldonrasib 1200 mg once daily plus daraxonrasib 300 mg once daily in advanced solid tumors with RAS G12D mutations. As of the February 9, 2026 data cutoff, 60 patients with RAS G12D metastatic PDAC who had previously received one or more prior lines of therapy were treated with the combination.
Zoldonrasib plus daraxonrasib demonstrated a manageable safety and tolerability profile that was broadly consistent with the established profile of daraxonrasib monotherapy. Grade 3 or greater TRAEs occurred in 35% of patients who received the combination. Among TRAEs occurring in 10% or more of all patients, the most common Grade 3 or greater events were rash (12%), anemia (10%), and stomatitis/mucositis (7%). Few patients discontinued due to TRAES; 2% discontinued zoldonrasib and 5% discontinued daraxonrasib. The mean dose intensity was 88% for zoldonrasib and 76% for daraxonrasib.
The zoldonrasib plus daraxonrasib combination demonstrated compelling antitumor activity in patients with previously treated metastatic PDAC. In the second line cohort (2L) (N=30), the ORR was 50% (95% CI: 31–69) and DCR was 97% (95% CI: 83–100). Median progression-free survival (PFS) in the 2L cohort was 9.6 months (95% CI: 7.1–NE), with a 6-month PFS rate of 71%. Median overall survival (OS) in the 2L cohort was not yet estimable, with a 6-month OS rate of 89%. In the third line and beyond (3L+) cohort (N=30), the ORR was 47% (95% CI: 28–66) and DCR was 90% (95% CI: 74–98). Median PFS in the 3L+ cohort was 7.6 months (95% CI: 4.6–10.5), with a 6-month PFS rate of 59%. Median OS in the 3L+ cohort was 10.5 months (95% CI: 6.7–NE), with a 6-month OS rate of 82%.
These safety and clinical activity data support the planned pivotal global, Phase 3 RASolute 309 clinical trial of zoldonrasib plus daraxonrasib versus GnP in patients with previously untreated RAS G12D metastatic PDAC.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. Pancreatic ductal adenocarcinoma, or PDAC, is the most common form of pancreatic cancer. Due to the lack of early symptoms and effective detection methods, approximately 80% of patients are diagnosed with advanced or metastatic disease. PDAC is the most commonly RAS-driven malignancy of all major cancers, with more than 90% of patients having tumors that harbor RAS mutations.1 RAS G12D is the most prevalent RAS mutation subtype in PDAC, occurring in 40% of patients, and has been associated with poorer outcomes than RAS wild-type disease and certain other RAS-mutant subgroups.1-4
About Zoldonrasib
Zoldonrasib is an investigational, oral RAS(ON) G12D-selective covalent tri-complex inhibitor. RAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers.1 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the U.S., and no targeted therapy is currently approved for these patients.5 Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236), as well as standard of care regimens in lung and gastrointestinal cancers.
About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent tri-complex inhibitor. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
Daraxonrasib is designed to target cancers driven by a broad range of common RAS genotypes, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC.
About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding our development strategy, including in RAS G12D pancreatic cancer; the potential of our product candidates for RAS(ON) inhibition, including in pancreatic cancer; the ability of daraxonrasib or zoldonrasib to improve patient outcomes; planned and ongoing clinical studies; and potential efficacy of the company’s product candidates being studied.
Forward-looking statements are typically, but not always, identified by the use of words such as “anticipate,” "estimate," "plan," “potential,” “proof-of-concept,” “pursuing,” "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 6, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
1 Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1);91. doi:10.1038/s41698-022-00334-z
2 Yousef, A., Yousef, M., Chowdhury, S. et al. Impact of KRAS mutations and co-mutations on clinical outcomes in pancreatic ductal adenocarcinoma. NPJ Precis Oncol. 2024;8:27. https://doi.org/10.1038/s41698-024-00505-0
3 Qian ZR, Rubinson DA, Nowak JA, et al. Association of Alterations in Main Driver Genes With Outcomes of Patients With Resected Pancreatic Ductal Adenocarcinoma. JAMA Oncol. 2018;4(3):e173420. doi:10.1001/jamaoncol.2017.3420
4 Norton C, Shaw MS, Rubnitz Z, et al. KRAS Mutation Status and Treatment Outcomes in Patients With Metastatic Pancreatic Adenocarcinoma. JAMA Netw Open. 2025;8(1):e2453588. doi:10.1001/jamanetworkopen.2024.53588
5 Estimated using tumor mutation frequencies from Foundation Medicine Insights March 2022 and scaled to estimated patient numbers using cancer incidence from ACS Cancer Facts and Figures 2023.
Revolution Medicines oznámila čtyři prezentace dat z programu RAS(ON) na kongresu ESMO o gastrointestinálních nádorech 2026. Dvě se zaměří na zoldonrasib v kombinaci u pacientů s metastatickým RAS G12D pankreatickým duktálním adenokarcinomem (PDAC).
REDWOOD CITY, Calif., June 24, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that four oral and poster presentations highlighting data from its RAS(ON) pipeline will be featured at the 2026 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress, taking place July 1–4, 2026 in Munich, Germany.
The program will include two oral presentations from Phase 1/2 trials evaluating zoldonrasib, an oral RAS(ON) G12D-selective covalent inhibitor, in combination regimens for patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC). These presentations will report results from zoldonrasib plus chemotherapy in the first line setting, and zoldonrasib plus daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in patients who had received one or more prior lines of therapy.
Additional presentations will include two Phase 3 trials-in-progress posters for RASolute 303, evaluating daraxonrasib as a monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard of care gemcitabine and nab-paclitaxel as a first line treatment for patients with metastatic PDAC, and RASolute 304, evaluating adjuvant daraxonrasib in patients with PDAC who have undergone resection and completed perioperative chemotherapy.
Details of Revolution Medicines’ presentations are listed below.
Revolution Medicines Oral Presentations:
Title:Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) in Patients with 2L+ KRAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)Abstract:#341OPresenter:Nilofer Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterSession:Proffered Paper SessionDate/Time:July 2; 2:50 p.m. – 3:00 p.m. CEST Revolution Medicines Posters:
Title:RASolute 304 – A Phase 3 Multicenter, Open-label, Randomized Study of Adjuvant Daraxonrasib Versus Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Adenocarcinoma (PDAC)Abstract:#472TiPPresenter:Michel Ducreux, M.D., Ph.D., Institut Gustave RoussySession:Upper Digestive – Biliary, ampullary and pancreatic cancerDate/Time:July 3; 3:30 p.m. – 4:30 p.m. CEST About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied.
Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 6, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
Revolution Medicines zahájila fázi III studie RASolute 305 se zoldonrasibem v kombinaci s chemoterapií v první linii metastatického RAS G12D PDAC. Studie sleduje přežití bez progrese a celkové přežití.
Key Takeaways Revolution Medicines initiated phase III RASolute 305 in first-line metastatic RAS G12D PDAC.The study compares zoldonrasib plus chemotherapy against placebo plus standard chemotherapy.Co-primary endpoints are PFS and OS, with safety, efficacy and quality-of-life measures assessed. Revolution Medicines (RVMD - Free Report) announced that it has begun treating patients in the phase III RASolute 305 study, evaluating its pipeline candidate zoldonrasib in combination with chemotherapy in first-line metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC).
Zoldonrasib is RVMD’s investigational oral RAS(ON) G12D-selective inhibitor designed to suppress the active RAS G12D mutation, one of the most common oncogenic drivers across cancers. As no approved targeted therapies currently exist for RAS G12D-mutated tumors, the candidate represents a potentially significant treatment opportunity. Per management, zoldonrasib has shown encouraging antitumor activity and a favorable safety profile in early clinical studies.
Year to date, RVMD shares have skyrocketed 112.9% against the industry’s 0.1% decline.
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RVMD’s RASolute 305 Study Design & Key EndpointsIn the global late-stage RASolute 305 study, the participants are being given either zoldonrasib plus investigator-selected standard-of-care chemotherapy or placebo plus chemotherapy. Chemotherapy options include modified FOLFIRINOX or the combination of gemcitabine and nab-paclitaxel, both established frontline treatment regimens for metastatic pancreatic cancer.
The study’s co-primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints include additional measures such as antitumor efficacy, safety, tolerability and patient-reported outcomes assessing quality of life.
The study is designed to evaluate whether combining zoldonrasib with frontline chemotherapy can improve survival outcomes for patients with metastatic RAS G12D PDAC.
Pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, is often diagnosed at an advanced stage due to limited early symptoms and detection options. More than 90% of PDAC tumors harbor RAS mutations, with RAS G12D present in about 40% of patients and associated with particularly poor outcomes. Metastatic PDAC remains one of the deadliest cancers in the United States, with a five-year survival rate of around 3%.
Beyond pancreatic cancer, Zoldonrasib is being evaluated both as a standalone therapy and in combination with other treatments, including daraxonrasib and standard-of-care regimens, across multiple lung and gastrointestinal cancer indications.
RVMD Expands Late-Stage Presence in Metastatic PDACRevolution Medicines is advancing a broad pancreatic cancer portfolio built around its proprietary RAS(ON) inhibitor platform. The company's strategy spans both previously treated and first-line metastatic PDAC. In addition to the late-stage RASolute 305 study evaluating zoldonrasib in metastatic RAS G12D PDAC, the company is developing its lead pipeline candidate daraxonrasib in the ongoing phase III RASolute 303 study, as a monotherapy and in combination with chemotherapy for the first-line treatment of metastatic PDAC.
In April, the company announced positive top-line data from the phase III RASolute 302 study, which evaluated daraxonrasib, in previously treated metastatic PDAC patients. The study successfully met its primary endpoints, demonstrating significant improvements in both OS and PFS versus standard chemotherapy.
RVMD's Zacks Rank & Stocks to ConsiderRevolution Medicines currently carries a Zacks Rank #3 (Hold).
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