Recursion, Pharmaceuticals

Recursion Pharmaceuticals Reports Promising Clinical Trial Results for FAP Treatment

10.12.2025 - 11:25:04

Recursion Pharmaceuticals US75629V1044

New clinical data from Recursion Pharmaceuticals has generated significant interest in the biotech sector. The company's recent Phase 1b/2 trial results for its drug candidate REC-4881, targeting familial adenomatous polyposis (FAP), indicate a potentially meaningful therapeutic effect. The findings, released on Monday, highlight both a measurable reduction in polyp burden and a sustained response after treatment cessation, positioning the compound as a possible first-in-class pharmacological option for this condition.

The TUPELO study evaluated REC-4881, an allosteric MEK1/2 inhibitor. Central findings from the trial include:
* A median 43% reduction in total polyp burden was observed after 12 weeks of treatment, with 75% of evaluable patients showing decreases.
* This reduction was maintained in 82% of patients through week 25. Twelve weeks after ending therapy, the median decline from baseline stood at 53%.
* The safety profile was deemed manageable, with the majority of adverse events being Grade 1 or 2. Grade 3 events were reported in 15.8% of participants, and no Grade 4 or higher events occurred.

These positive clinical developments arrive against a backdrop of the company's latest financial figures. For the third quarter, Recursion posted revenue of $5.2 million alongside a net loss of $162.3 million. A critical point of strength is the firm's cash position, which was approximately $785 million as of October 9. Management believes this provides a financial runway through the end of 2027. The balance sheet is further supported by non-dilutive funding from partnerships, including a recent $30 million milestone payment from Roche/Genentech. In total, collaborations have contributed over $500 million.

Regulatory Pathway and Leadership Transition

The data suggest REC-4881 could be the first MEK1/2 inhibitor clinically developed for FAP. The asset has already secured regulatory designations, including Fast Track and Orphan Drug status from the U.S. FDA and an Orphan designation from the European Commission. Recursion has outlined plans to engage with the FDA in the first half of 2026 to discuss potential registration pathways. The company also intends to expand the study's eligibility criteria from patients aged 55 and older to include those 18 and above.

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This period of clinical progress coincides with a planned executive transition. Founder and current CEO Chris Gibson is scheduled to become Chairman of the Board of Directors effective January 1, 2026. He will be succeeded by Dr. Najat Khan, the company's present Chief R&D and Commercial Officer, who will assume the roles of CEO and President.

Market Perspective and Forward Look

While the TUPELO trial results point to genuine therapeutic potential for REC-4881, significant steps remain, including further regulatory discussions and additional clinical data. The upcoming FDA dialogue in early 2026 and the leadership change are key near-term milestones for investors to watch.

The current analyst consensus, as of December 9, sits between "Hold" and "Moderate Buy." The average price target is around $7.25, implying an approximate 52% upside from the closing share price of $4.77 on December 9.

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