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RVMD News
RVMD Events
Revolution Medicines' Rasonque Approved by FDA, Priced at $39,800
Revolution Medicines disclosed that following FDA approval of Rasonque for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy, once-daily oral tablets are now available in the United States for physicians to prescribe to eligible patients. The wholesale acquisition cost of Rasonque is $39,800 for a 30-day supply, based on the recommended daily dose.
Revolution Medicines' RASONQUE Approved by FDA for Metastatic Pancreatic Cancer
Revolution Medicines announced that the U.S. Food and Drug Administration has approved RASONQUE once-daily oral tablets, for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE represents the first targeted cancer medicine to be approved from a groundbreaking new class of RAS(ON) multi-selective and mutant-selective inhibitors. The FDA approval of RASONQUE is based on data from RASolute 302, a global, randomized Phase 3 trial evaluating RASONQUE versus investigator's choice of cytotoxic chemotherapy in patients with previously treated metastatic PDAC. The trial met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat population, which included patients with or without an identified tumor RAS mutation.
RBC Capital Expects Incyte to Update KRAS G12D Data
Incyte (INCY) is expected to report updated data for KRAS G12D inhibitor '734, in combination with mFOLFIRINOX and GemNabP, at ESMO in October, with previous data showing "too little" to have drawn any meaningful conclusions, RBC Capital tells investors in a research note. The firm, which has a Sector Perform rating and $109 price target on Incyte shares, believes the update will look "very competitive" and support the ongoing phase III efforts in 1L PDAC and that initial data appears generally comparable to Revolution Medicines' (RVMD) zoldonrasib.
BeOne and Revolution Medicines Announce Multi-Part Collaboration
BeOne Medicines (ONC) and Revolution Medicines (RVMD) announced a multi-part collaboration including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines' four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets. Clinical collaboration will explore potential targeted combination approaches for patients with RAS-addicted cancers. Potential drug combinations for development as part of the clinical collaboration will include certain BeOne assets and Revolution Medicines' four clinical RAS(ON) inhibitors. Under the regional rights agreement, Revolution Medicines has granted BeOne exclusive rights in select Asian markets to develop and commercialize or solely commercialize, depending on the market, these four clinical-stage RAS(ON) inhibitors. Revolution Medicines is eligible to receive development and sales milestone payments and tiered royalties on net sales in the partnered region. Revolution Medicines retains development and commercial rights to all its assets outside of the licensed territory, including Japan and South Korea. As part of this multi-part arrangement, BeOne will fund and conduct a global registrational Phase 3 study for one of Revolution Medicines RAS(ON) inhibitors, while Revolution Medicines continues to advance a broad range of global registrational studies across its portfolio.
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