Recursion said it expects to launch its first registrational trial in the second half of 2027 for REC-4881, an oral allosteric MEK1/MEK2 inhibitor, after positive mid-stage data in oral familial adenomatous polyposis (FAP). The program is based on updated findings from the Phase Ib/II TUPELO trial. REC-4881 reduced both the number of larger, higher-risk polyps and overall lower GI polyp burden, according to the company’s latest data presentation at the Collaborative Group of the Americas on Inherited Gastrointestinal Cancer meeting. Recursion framed the readout as a proof point for what it is building to do in lifelong diseases without approved pharmacologic therapies. The company said timing for the registrational trial depends on talks with the FDA, indicating ongoing regulatory alignment work rather than a finalized path. REC-4881 is licensed from Takeda under a 2020 global licensing deal that included development and regulatory milestone payments. For the FAP market, the key event is the move from mid-stage signals to a planned registrational start—an inflection point likely to determine whether oral MEK modulation can shift standard-of-care beyond surveillance and prophylactic surgery.
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