TLDR
- Revolution Medicines stock surged ~38–40% in premarket trading Monday to around $134
- Phase 3 trial of daraxonrasib showed median overall survival of 13.2 months vs. 6.7 months for standard chemotherapy
- The once-daily oral pill targets RAS mutations, found in over 90% of pancreatic cancer cases
- Revolution Medicines plans to file a New Drug Application with the FDA under a priority voucher
- RBC Capital Markets estimates a $10 billion-plus market opportunity for the drug
Revolution Medicines posted one of the more eye-catching premarket moves on Monday after its Phase 3 trial results for daraxonrasib came in well above expectations.
Revolution Medicines, Inc., RVMD
The once-daily oral pill nearly doubled median overall survival compared to standard chemotherapy in previously treated patients with metastatic pancreatic ductal adenocarcinoma — 13.2 months versus 6.7 months.
That result cleared the bar analysts had set. RBC Capital Markets analyst Leonid Timashev had flagged 11–12 months as the investor benchmark for overall survival heading into the readout.
The drug targets RAS mutations, which are present in more than 90% of pancreatic cancer cases and are a known driver of tumor growth. The trial included patients with a wide range of RAS variants, as well as those without an identified RAS mutation.
Pancreatic cancer carries one of the lowest five-year survival rates of any cancer, sitting around 13%. Treatment options for patients who have already been through first-line therapy are limited.
“For patients with metastatic pancreatic cancer, new treatment options are urgently needed to increase survival time and improve quality of life,” said Brian Wolpin, professor of medicine at Harvard Medical School and the principal investigator for the trial.
FDA Submission in the Works
Revolution Medicines said it plans to submit the trial data to global regulators, including the FDA, as part of a future New Drug Application. The submission will be made under a Commissioner’s National Priority Voucher, which shortens the review timeline.
CEO Mark Goldsmith said the results “underscore daraxonrasib’s potential to redefine the treatment landscape.”
RBC Capital Markets puts the total market opportunity for daraxonrasib at more than $10 billion.
RVMD stock was up around 38–40% in premarket trading, hitting approximately $134. Coming into Monday, the stock had already gained 164% over the prior 12 months.
Acquisition Talk Resurfaces
Revolution Medicines has attracted takeover interest in recent months. AbbVie denied reports in January that it was in acquisition talks with the company. Shortly after, The Wall Street Journal reported that separate discussions with Merck had also ended.
No deal has materialized, and Revolution Medicines has not confirmed any active negotiations.
The Phase 3 trial enrolled previously treated patients whose tumors harbored a wide range of RAS variants, making the dataset broader than some earlier-stage trials in this space.
Daraxonrasib is taken orally once per day, a logistical advantage over intravenous chemotherapy for patients managing treatment on an ongoing basis.
The full data set is expected to be submitted to regulatory authorities as part of the formal marketing application process.
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