Revolution Medicines (NASDAQ: RVMD) gets FDA OK for cancer pill with list price
Rhea-AI Filing Summary
Revolution Medicines, Inc. (RVMD) announced that on August 26, 2026, the U.S. Food and Drug Administration approved RASONQUE™ (daraxonrasib) for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
The approval is based on the global, randomized Phase 3 RASolute 302 trial comparing RASONQUE with investigator’s choice of cytotoxic chemotherapy in previously treated metastatic pancreatic adenocarcinoma. Once-daily oral RASONQUE tablets are now available in the United States, with a wholesale acquisition cost of $39,800 for a 30-day supply at the recommended daily dose.
Positive
- FDA approval of RASONQUE for metastatic pancreatic adenocarcinoma provides Revolution Medicines with an approved once-daily oral therapy now available in the U.S., supported by the Phase 3 RASolute 302 trial, and creates a commercial opportunity at a wholesale acquisition cost of $39,800 for a 30-day supply.
Negative
- None.
Insights
Analyzing...
8-K Event Classification
Item 8.01 — Other Events
1 item
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Key Figures
FDA approval date: August 26, 2026
Wholesale acquisition cost: $39,800
Supply duration at stated cost: 30-day supply
+1 more
4 metrics
FDA approval date
August 26, 2026
Date RASONQUE (daraxonrasib) was approved for metastatic pancreatic adenocarcinoma
Wholesale acquisition cost
$39,800
Cost for a 30-day supply of RASONQUE at the recommended daily dose
Supply duration at stated cost
30-day supply
Duration covered by the $39,800 wholesale acquisition cost for RASONQUE
Warrants share fraction
0.1112 shares of common stock per warrant
Warrants to purchase a fraction of RVMD common stock expiring 2026
Key Terms
metastatic pancreatic adenocarcinoma, wholesale acquisition cost, Phase 3 clinical trial, cytotoxic chemotherapy, +1 more
5 terms
metastatic pancreatic adenocarcinoma medical
"for the treatment of adult patients with metastatic pancreatic adenocarcinoma"
wholesale acquisition cost financial
"The wholesale acquisition cost of RASONQUE is $39,800 for a 30-day supply"
Wholesale acquisition cost (WAC) is the manufacturer’s published price for a drug sold to wholesalers before discounts, rebates or other price concessions; think of it as the sticker price a maker sets for bulk buyers. Investors track WAC because it affects a company’s reported revenue potential, pricing power and profit margins, and because deviations between WAC and the actual net price can signal competitive pressure, reimbursement changes, or hidden costs.
Phase 3 clinical trial medical
"a global, randomized Phase 3 clinical trial evaluating RASONQUE"
A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.
cytotoxic chemotherapy medical
"evaluating RASONQUE versus investigator’s choice of cytotoxic chemotherapy"
Cytotoxic chemotherapy are drugs that kill rapidly dividing cells, commonly used to treat cancer by damaging the cells’ ability to reproduce. Think of them as a targeted weedkiller that removes fast-growing plants but can also harm surrounding healthy tissue; for investors this matters because effectiveness, side effects, and safety profiles drive clinical adoption, regulatory approval, market size, and revenue predictability for companies developing or selling these treatments.
investigator’s choice medical
"evaluating RASONQUE versus investigator’s choice of cytotoxic chemotherapy"
FAQ
What did RVMD disclose in this Form 8-K?
Revolution Medicines reported that the FDA approved RASONQUE™ (daraxonrasib) for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy, and that the drug is now commercially available in the United States.
For which patients is RASONQUE now approved according to RVMD?
RASONQUE is approved for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy, providing a new treatment option for previously treated or more fragile patients.
What clinical trial supported the FDA approval of RASONQUE for RVMD?
The approval is based on data from RASolute 302, a global, randomized Phase 3 clinical trial that evaluated RASONQUE versus investigator’s choice of cytotoxic chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.
How is RASONQUE administered according to RVMD’s 8-K?
RASONQUE is provided as once-daily oral tablets. These tablets are now available in the United States for physicians to prescribe to eligible adult patients with metastatic pancreatic adenocarcinoma under the approved indication.
What is the price of RASONQUE reported by RVMD (RVMD)?
Revolution Medicines states that the wholesale acquisition cost of RASONQUE is $39,800 for a 30-day supply, based on the recommended daily dose of the once-daily oral tablets.
When did the FDA approve RASONQUE for RVMD?
The U.S. Food and Drug Administration approved RASONQUE on August 26, 2026 for the treatment of adult patients with metastatic pancreatic adenocarcinoma under the conditions described in the approval.
AI-generated analysis. How Rhea-AI works. Not financial advice.
