The Food and Drug Administration (FDA) cleared the once-daily tablet, Rasonque, for certain adults with metastatic pancreatic adenocarcinoma.
- The agency approved the drug merely weeks after the company filed its application in July.
- In an SEC filing, the company set a wholesale acquisition cost of $39,800 for a 30-day supply of Rasonque at the recommended daily dose.
- RBC Capital Markets told Reuters that the market can support premium pricing and estimated roughly $28 million in U.S. sales this quarter.
Shares of Revolution Medicines (RVMD) traded flat on Wednesday after U.S. regulators approved Rasonque (daraxonrasib) for advanced pancreatic cancer, making it the company’s first commercial drug.
The Food and Drug Administration (FDA) cleared the once-daily tablet for adults with metastatic pancreatic adenocarcinoma who have already had at least one systemic treatment, or who cannot take combination chemotherapy. The agency approved the drug merely five weeks after the agency accepted its application.
However, stock reaction stayed muted as investors focused on whether payers will cover the drug after the company set a wholesale acquisition cost of $39,800 for a 30-day supply.
What The Trial Showed
The approval rested on RASolute 302, a late-stage study of about 500 previously treated patients. Patients on Rasonque lived a median 13.2 months in the trial, versus 6.7 months on standard chemotherapy — a 60% lower risk of death. Time before the cancer worsened also roughly doubled. Side effects were common, including rash, diarrhea and mouth sores, but fewer patients quit the pill than chemotherapy.
RAS proteins act like a growth switch in most pancreatic tumors. Rasonque is designed to shut several forms of RAS at once.
Speedy Approval
The FDA gave the drug Breakthrough Therapy and Orphan Drug status, then placed it in the Commissioner’s National Priority Voucher program, which shortens review. Late-stage results landed in April. The agency opened expanded access in May, allowing the drug to be administered outside a clinical trial but before approval; more than 2,000 patients received the drug under the pathway. The formal application seeking approval was accepted in July. FDA usually takes 10-12 months on an application.
Launch And Pricing
Rasonque 300 mg tablets are immediately available by prescription in the United States. In an SEC filing, the company set a wholesale acquisition cost of $39,800 for a 30-day supply at the recommended daily dose — about $477,600 a year before rebates, discounts or patient assistance. Most of that cost typically falls to insurers, not patients.
RBC Capital Markets told Reuters that the market can support premium pricing and estimated roughly $28 million in U.S. sales this quarter, with a steeper ramp in the fourth quarter. The analyst expects the drug could generate $11.5 billion in annual sales in the longer term.
This is Revolution’s first approved product and the proof point for its RAS strategy. Chief executive Mark Goldsmith called the decision a “monumental step” and said the data positions Rasonque as a new standard of care. The company is already running studies for the drug in earlier pancreatic cancer and in RAS-driven lung cancer.
How Did RVMD Retail Traders React?
On Stocktwits, retail sentiment around RVMD stock jumped from ‘neutral’ to ‘bullish’ over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user expressed disappointment that the stock didn't rally big on the approval.
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Another user highlighted the company’s high total addressable market. According to the National Cancer Institute, about 67,000 new cases of pancreatic cancer are diagnosed in the U.S. each year, of which a majority are pancreatic adenocarcinoma.
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A third user expressed optimism for the drug also getting approved in the treatment of other tumors besides pancreatic cancer.
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RVMD stock has gained 165% year-to-date.
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