Revolution Medicines shares fall on new FDA review documents for Rasonque

Shares of Revolution Medicines dropped 6% on October 8, 2026 after newly disclosed FDA review documents showed varying efficacy for its pancreatic cancer drug Rasonque across KRAS mutation subgroups. While Rasonque demonstrated strong efficacy in G12V mutations, its benefit was more modest in the common G12D population and worse in G12R mutations. Analysts described the market sell-off as overdone, though some noted a potential opening for G12D-specific competitors.

Subgroup efficacy findings in FDA review

• ▪In trial enrollees with the KRAS G12D mutation, which represents the largest share of pancreatic cancer patients, Rasonque showed a lower response rate than the overall patient population and a more modest difference compared to chemotherapy
• ▪FDA review documents showed that clinical results for Rasonque were worse in pancreatic cancer patients carrying a KRAS G12R mutation compared to chemotherapy
• ▪FDA review documents revealed that tumor responses to Rasonque were markedly better than chemotherapy in trial enrollees carrying the KRAS G12V mutation
• ▪FDA review documents released on October 8, 2026 suggested that Revolution Medicines' pancreatic cancer drug Rasonque might be less effective in certain patient subgroups

Market and analyst reaction to disclosure

• ▪Leerink Partners analyst Andrew Berens stated that the modest efficacy of Rasonque in G12D mutation patients, as shown in newly disclosed FDA review documents, creates an opportunity for competitor biotechs developing G12D-specific inhibitors or next-generation therapies
• ▪Leerink Partners analyst Andrew Berens described the disclosure of FDA review documents as a crack in the armor for Rasonque
• ▪Multiple Wall Street analysts defended Revolution Medicines following its 6% share decline on October 8, 2026, describing the stock sell-off in client notes as overdone, misguided, or an investor overreaction
• ▪Revolution Medicines shares fell 6% on October 8, 2026 following the public release of the FDA review documents for Rasonque