Recursion Pharmaceuticals Reports Positive Phase 1b/2 Results for REC‑4881 in Familial Adenomatous Polyposis

RXRX
December 08, 2025

Recursion Pharmaceuticals disclosed that its investigational MEK1/2 inhibitor REC‑4881 achieved a 43% median reduction in polyp burden after 12 weeks of therapy in the TUPELO Phase 1b/2 study of patients with familial adenomatous polyposis (FAP). At week 25—12 weeks after treatment cessation—83% of evaluable patients maintained a reduction in polyp burden, underscoring the durability of the therapeutic effect.

The results are particularly striking because FAP is a hereditary condition that almost guarantees colorectal cancer without intervention, and no medical therapy has been approved to date. A durable, non‑surgical option could transform patient care, reduce the need for prophylactic colectomies, and address a substantial unmet medical need. The data also confirm Recursion’s AI‑driven platform’s ability to translate phenotypic insights into clinically relevant outcomes, reinforcing the company’s core technology proposition.

Regulatory strategy is already in motion: Recursion plans to engage the FDA in the first half of 2026 to define a registration pathway, and the drug has received Fast Track and Orphan Drug designations in the United States and Europe. The company also intends to broaden the TUPELO trial to include patients aged 18 and older, expanding the potential market. These milestones position REC‑4881 as a flagship asset that could generate future revenue streams and validate the scalability of Recursion’s discovery pipeline.

Financially, Recursion reported a Q3 2025 revenue of $5.2 million—well below analyst expectations of $16.95 million—reflecting the company’s ongoing focus on R&D and limited commercial activity. However, the firm maintains a strong cash position of approximately $785 million as of October 9 2025, providing a runway through the end of 2027. The positive clinical data are expected to bolster investor confidence in the company’s long‑term growth prospects, even as short‑term revenue remains modest.

Market reaction to the announcement was positive: the company’s shares rose 1.91% to $4.81 following the disclosure, reflecting investor enthusiasm for the durable efficacy data and the validation of Recursion’s AI platform. Analysts highlighted the significance of a first‑in‑disease result in a high‑need area and the potential for a future commercial opportunity.

"These Phase 2 results mark a meaningful validation of the Recursion OS," said CEO Chris Gibson. "An unbiased phenotypic insight from our platform has translated into rapid, substantial, and durable reductions in polyp burden in patients with FAP, a disease with no approved medical therapies." Principal Investigator Jessica Stout added, "The durable polyp burden reduction demonstrated by REC‑4881, especially the sustained effect seen at Week 25, is highly encouraging for the FAP community."

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