Aug. 27 at 8:44 PM
$SLS $MRK $RVMD Rasonque FDA Approval
Drug Pricing
$39,800 Per MONTH \
$475K Rev Per Patient Per Year
- We've Estimated Gps at
$300K Y1 based on XCCO analogue comps.
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$300K Rev Per Patient May be Low for GPS
Speedy Approval RVMD
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.
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.
https://finance.yahoo.com/healthcare/articles/rvmd-stock-stays-flat-despite-195204819.html
