Revolution Medicines stock (RVMD) moved higher on Wednesday after the FDA approved its once-daily pill Rasonque for the treatment of metastatic pancreatic adenocarcinoma. The shares rose about 1% in early trading before giving back some of those gains later in the session.

Revolution Medicines, Inc. (RVMD) has already climbed more than 165% year-to-date, making the approval the latest milestone in a strong run for the biotechnology company.

The FDA decision came months ahead of schedule. The agency had only accepted the company’s New Drug Application for review on July 22, making Wednesday’s approval a notably fast turnaround by regulatory standards.

Rasonque is the brand name for daraxonrasib, a once-daily RAS inhibitor. The drug targets RAS proteins, which function as molecular switches inside cells and are a major driver of tumor growth in most pancreatic cancer patients. KRAS, the most frequently altered member of the RAS family, is mutated in roughly 90% of pancreatic ductal adenocarcinomas, and the target was long considered “undruggable” before the first approved KRAS inhibitors reached US patients in recent years.

The medicine drew wider public attention after former Nebraska Sen. Ben Sasse, who was diagnosed with late-stage metastatic pancreatic cancer last year, called it a “miracle drug” after enrolling in a clinical trial.

The FDA had previously granted daraxonrasib Breakthrough Therapy Designation in June 2025, followed by Orphan Drug designation and priority review status — programs designed to accelerate the development and review of drugs for serious conditions — underscoring the speed of the regulatory process.

Phase 3 Trial Data

The approval was supported by a Phase 3 trial involving 500 patients, with results published in the New England Journal of Medicine. Patients treated with Rasonque lived a median of 13.2 months, compared with 6.7 months for those receiving standard chemotherapy.

The risk of death fell by 60%. More than half of the Rasonque patients were still alive at one year, compared with fewer than one in five in the chemotherapy group. The time before the disease worsened also roughly doubled, from 3.6 months to 7.2 months.

Acting FDA Commissioner Kyle Diamantas described the approval as “a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.”

Why This Market Matters

Pancreatic adenocarcinoma accounts for 90% to 95% of the roughly 67,000 new pancreatic cancer cases diagnosed in the US each year. Although pancreatic cancer represents about 3.2% of all cancer diagnoses, it is responsible for a disproportionately large number of cancer deaths because it is often detected late and has limited treatment options. The disease is currently the third-leading cause of cancer death in the US, and its five-year survival rate remains around 13%, among the lowest of all major cancer types.

Revolution Medicines first highlighted the drug’s potential in April, when Phase 3 trial results sparked a sharp move in the stock. A month later, the FDA issued a “safe to proceed” letter allowing the company to provide daraxonrasib to patients outside a clinical trial.

The company is now studying Rasonque as a first-line treatment for pancreatic cancer and in other RAS-driven cancers, including lung and colorectal cancers, where RAS mutations are also common drivers of tumor growth.

On Wall Street, RVMD carries a Strong Buy consensus from analysts, based on 18 Buy ratings and 1 Hold. The average price target is $222.89, while the highest target is $291.