FDA Approves RASONQUE (daraxonrasib) for Metastatic Pancreatic Cancer; Priced at $39,800/Month
RVMD has more than doubled off its 52-week low of $35.62.
Summary
Revolution Medicines received FDA approval for RASONQUE (daraxonrasib) for previously treated metastatic pancreatic cancer, with a wholesale acquisition cost of $39,800 per 30-day supply. The drug is now commercially available in the U.S.
Key Events · Product Development and Regulatory · RVMD
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FDA Approves RASONQUE for Pancreatic Cancer
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.
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Commercial Launch Underway
Once-daily oral RASONQUE tablets are now available in the United States for physicians to prescribe, marking the company's first commercial product.
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Pricing Set at $39,800 per 30-Day Supply
The wholesale acquisition cost is $39,800 for a 30-day supply based on the recommended daily dose, implying approximately $478,000 annually per patient.
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Approval Based on Phase 3 RASolute 302
The approval was supported by data from the global, randomized Phase 3 RASolute 302 trial comparing RASONQUE versus investigator's choice of cytotoxic chemotherapy in previously treated metastatic pancreatic adenocarcinoma.
Analysis · RVMD · Life Sciences
The FDA approval of RASONQUE is a thesis-altering event for Revolution Medicines. The company now has its first commercial product in a high-unmet-need indication — metastatic pancreatic adenocarcinoma — with a wholesale acquisition cost of $39,800 for a 30-day supply. This converts a clinical-stage pipeline into a revenue-generating commercial enterprise. The approval follows the Phase 3 RASolute 302 data that showed daraxonrasib doubled progression-free survival, and the stock is trading near its 52-week high at $213, reflecting the market's anticipation. The pricing disclosure is the key new fact: at roughly $478,000 annually per patient, this is a premium oncology therapeutic with significant revenue potential. The company's $45 billion market cap already prices in substantial commercial success, so execution on launch and reimbursement will be the next test.
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At the time of this filing, RVMD was trading at $213.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $45.3B. The 52-week trading range was $35.62 to $220.34. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.